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- Title:
- MCTC071 Guidance | eInvestigator Site File Filing (eISF) for MCRI sponsored clinical trials
- Topic:
- Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Melbourne Children's Trials Centre
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.2
- Date of Publication:
- 01/12/2022
- Title:
- MCTC014 Guidance | Filing definitions and Principles
- Topic:
- Data Records Reporting Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.0
- Date of Publication:
- 02/03/2022
- Title:
- MCTC079 SOP | Data sharing and access procedure for the release of data from the Murdoch Children's sponsored investigator-initiated clinical trials
- Topic:
- Data Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Natalie Rose, Laura Galetta (CRDO, MCTC)
- Version #:
- 1.0
- Date of Publication:
- 20/10/2020
- Title:
- MCTC050 Guidance | Data and Safety Monitoring Boards (DSMB)
- Topic:
- Monitoring / QA Data Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 08/07/2021
- Title:
- MCTC051 Template | DSMB Charter
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 07/07/2021
- Title:
- MCTC137 Form | MCRI Sponsorship Committee Annual Progress Report
- Topic:
- Sponsorship
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Form
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 01/01/2022
- Title:
- MCTC038 Guidance | Setting up a research project budget
- Topic:
- Other Finance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 10/11/2016
- Title:
- MCTC036 Template | Budgets
- Topic:
- Other Finance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 18/05/2016
- Title:
- MCTC003 Guidance | Developing, amending and complying with research protocols
- Topic:
- Protocol
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 11/10/2017
- Title:
- MCTC063 Template | Melbourne Children's clinical trial (drug or device intervention) protocol
- Topic:
- Protocol
- Applicability:
- Intervention: drug/device
- Department:
- Function:
- Template
- Author:
- CRDO & CEBU (CRDO)
- Version #:
- 5.0
- Date of Publication:
- 19/12/2024
- Title:
- MCTC029 Template | Study/Trial Steering Committee (SSC/TSC) Charter
- Topic:
- Governance Protocol Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 22/09/2020
- Title:
- MCTC052 Template | DSMB Meeting Agenda
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC053 Template | DSMB Open Report
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC045 Workflow | Clinical Trial Contracts, Indemnities and Clinical Trial Notification Process Map
- Topic:
- Governance Approvals Reporting Other
- Applicability:
- Intervention: drug/device Other
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 19/12/2017
- Title:
- MCTC027 Form | Certificate of Sponsorship
- Topic:
- Sponsorship
- Applicability:
- Intervention: drug/device Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 24/03/2020
- Title:
- MCTC026 SOP | Clinical Trial Registration of Investigator-Initiated Trials (IITs)
- Topic:
- Governance Reporting Other
- Applicability:
- Intervention: drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.2
- Date of Publication:
- 04/07/2024
- Title:
- MCTC013 Guidance | Site Investigator File (SIF) Essential Document Filing
- Topic:
- Records
- Applicability:
- Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 02/06/2021
- Title:
- MCTC116 Template | SIF Paper binder section dividers
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC011 Guidance | Investigator Site File - Table of Contents Document Filing
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC118 Template | ISF Paper binder section dividers
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC117 Template | ISF Table of Contents
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC002 SOP | Copying and Certifying Essential Documents
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Natalie Rose (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 17/05/2018
- Title:
- MCTC106 Guidance | Principles of the General Data Protection Regulation (GDPR) & Data Protection in a Research Context
- Topic:
- Governance Reporting Data
- Applicability:
- Other Quality Assurance Intervention: no drug/device Intervention: drug/device Observational
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC107 Factsheet | GDPR Guidelines for Researchers: Information Sheet & Quick Facts
- Topic:
- Governance Reporting Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC170 SOP | Archiving Clinical Trial Investigator Site Files
- Topic:
- Data Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Angela Karandaglidis (Clinical Trial Assistant)
- Version #:
- 1.0
- Date of Publication:
- 12/04/2024
- Title:
- MCTC009 Form | Sample Protocol Feasibility Checklist
- Topic:
- Protocol
- Applicability:
- Intervention: no drug/device Intervention: drug/device
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 25/01/2023
- Title:
- MCTC049 Template | Study task timeline
- Topic:
- Other Approvals
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 12/04/2017
- Title:
- MCTC056 Form | Checklist for Trial development and Start-up
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 09/08/2021
- Title:
- MCTC016 Template | Notification of Site Activation
- Topic:
- Other Approvals Governance Protocol Reporting
- Applicability:
- Observational Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 04/01/2020
- Title:
- MCTC135 SOP | Establishing International Clinical Trials
- Topic:
- Other Governance Approvals
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 18/08/2021
- Title:
- MCTC139 SOP | Site Initiation for MCRI-Sponsored Clinical Trials
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 02/03/2022
- Title:
- MCTC139.01 Factsheet | Site Initiation for MCRI-Sponsored Trials
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Factsheet
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.1
- Date of Publication:
- 07/09/2021
- Title:
- MCTC122 Template | Site Initiation Booking Confirmation Letter
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.1
- Date of Publication:
- 23/08/2021
- Title:
- MCTC132 Template | Site Initiation Meeting Agenda
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: no drug/device Intervention: drug/device Observational
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 03/02/2022
- Title:
- MCTC140 Template | Essential document request letter prior to site initiation
- Topic:
- Approvals Governance Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC141 Template | Site Initiation Follow up Letter
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC142 Template | Site Initiation Follow up Report
- Topic:
- Approvals Governance Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC033 SOP | Regulatory Green Light Approval for Clinical Trial Site Activation
- Topic:
- Approvals Governance Other Protocol
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 08/09/2021
- Title:
- MCTC034 Template | Regulatory Green Light Approval Form
- Topic:
- Approvals Governance Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 08/09/2021
- Title:
- MCTC035 Template | Risk Assessment and Risk Management Tool for Clinical Trials
- Topic:
- Sponsorship Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- MCTC (MCTC)
- Version #:
- 2.0
- Date of Publication:
- 05/10/2020
- Title:
- MCTC061 SOP | Continuous improvement: A Corrective and Preventative Action (CAPA) Plan
- Topic:
- Safety Reporting Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC080 Template | CAPA Plan
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC081 Template | CAPA Tracking Log
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC005 SOP | Safety Monitoring and Reporting Procedure for MCRI-Sponsored IITs of Medicines/Medical Devices
- Topic:
- Monitoring / QA Other Safety Reporting
- Applicability:
- Intervention: drug/device
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Kate Scarff (CRDO Lead)
- Version #:
- 2.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC008 Template | Expedited Safety Report Form
- Topic:
- Safety Reporting
- Applicability:
- Intervention: no drug/device Intervention: drug/device
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 18/03/2020
- Title:
- MCTC018 Template | Clinical Review of Safety Events
- Topic:
- Safety Reporting Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 29/07/2022
- Title:
- MCTC094 Process Map | Responsibilities of Site PIs in MCRI-sponsored IITs: Safety Assessment, Documentation and Reporting
- Topic:
- Safety Reporting Staff
- Applicability:
- Intervention: drug/device Observational Intervention: no drug/device
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 18/03/2020
- Title:
- MCTC095 Process Map | Responsibilities of the Sponsor-Investigator in MCRI-sponsored IITs: Safety Assessment, Documentation and Reporting
- Topic:
- Safety Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 18/03/2020
- Title:
- MCTC096 Timeline | Safety Reporting Timelines: Studies with Investigational Medicinal Products (IMPs)
- Topic:
- Safety Reporting
- Applicability:
- Intervention: drug/device
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/03/2020
- Title:
- MCTC097 Timeline | Safety Reporting Timelines: Studies with Investigational Medical Devices (IMDs)
- Topic:
- Safety Reporting
- Applicability:
- Intervention: drug/device
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/03/2020
- Title:
- MCTC123 SOP | MCRI Sponsor-Investigator Management of Non-Compliance: Protocol Deviations and Serious Breaches
- Topic:
- Protocol Reporting Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Natalie Rose, Kate Scarff (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 24/03/2022
- Title:
- MCTC124 Form | Non-Compliance Report
- Topic:
- Reporting Protocol Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other Quality Assurance
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 28/03/2022
- Title:
- MCTC125 Form | Non-Compliance Review
- Topic:
- Reporting Protocol Safety Other Governance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 23/03/2022
- Title:
- MCTC127 Template | Site Non-Compliance Log
- Topic:
- Monitoring / QA Protocol Reporting Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 30/06/2021
- Title:
- MCTC126 Template | Central Non-Compliance Log
- Topic:
- Other Safety Reporting Protocol Governance
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 30/06/2021
- Title:
- MCTC128 Timeline | Non-Compliance Reporting
- Topic:
- Reporting Safety Protocol Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 23/03/2022
- Title:
- MCTC046 SOP | Monitoring Visit Activities for Clinical Trials of Investigational Products
- Topic:
- Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Kate Scarff (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 08/11/2018
- Title:
- MCTC047 Template | Clinical Monitoring Plan for IITs
- Topic:
- Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 01/05/2018
- Title:
- MCTC068 Template | Monitoring Visit Report
- Topic:
- Monitoring / QA Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 19/03/2020
- Title:
- MCTC093 Template | Participant-Level Monitoring Form for IITs
- Topic:
- Monitoring / QA Recruitment Reporting Other Consent Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 08/11/2018
- Title:
- MCTC072 Factsheet | Using Teams for Trial Monitoring
- Topic:
- Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC073 Factsheet | Access Parkville Connect for Trial Monitoring
- Topic:
- Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Factsheet
- Author:
- Iona Walton (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 21/10/2024
- Title:
- MCTC028 Template | Note to File
- Topic:
- Records Other Governance Monitoring / QA Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 4.0
- Date of Publication:
- 13/06/2023
- Title:
- MCTC042 SOP | Investigator's Brochure Content, Design, Amendments, Filing & Distribution
- Topic:
- Data Other Staff Sponsorship Records Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Fiona Williams (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 09/11/2017
- Title:
- MCTC043 Flowchart | Ethics & Governance Process for Stand Alone Sites
- Topic:
- Ethics Governance Other Approvals
- Applicability:
- Intervention: no drug/device Observational Intervention: drug/device Other
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 11/10/2017
- Title:
- MCTC044 Flowchart | Ethics & Governance Process for Lead and Accepting Sites
- Topic:
- Approvals Ethics Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 10/10/2017
- Title:
- MCTC069 Guidance | eTMF Filing Guideline
- Topic:
- Monitoring / QA Other Software Records Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 01/06/2021
- Title:
- MCTC070 Guidance | eSIF Filing Guidelines
- Topic:
- Data Monitoring / QA Records Other Software
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 01/06/2021
- Title:
- MCTC099 Form | Wet Ink Signature Page
- Topic:
- Software Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- Iona Walton (CRDO)
- Version #:
- 2.1
- Date of Publication:
- 07/03/2024
- Title:
- MCTC104 Guidance | eISF Workflows and eSignature Reference Guide for IITs
- Topic:
- Software Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 03/12/2020
- Title:
- MCTC105 Guidance | eTMF Workflows and eSignature Reference Guide for IITs
- Topic:
- Software Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 03/12/2020
- Title:
- MCTC108 Template | Data Protection Checklist
- Topic:
- Approvals Consent Ethics Data Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Template
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC065 SOP | Study Start up for Clinical Trials
- Topic:
- Approvals Governance Other Records Ethics Monitoring / QA Protocol
- Applicability:
- Intervention: drug/device Observational Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 2.0
- Date of Publication:
- 05/04/2023
- Title:
- MCTC172 Factsheet | CAAA IATA Shippers Training Course Booking Process
- Topic:
- Safety Staff Other Equipment
- Applicability:
- Intervention: drug/device Other
- Department:
- Function:
- Factsheet
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 06/02/2023
- Title:
- MCTC177 Form | eTMF Filing Index for IITs
- Topic:
- Records Other Software
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 28/02/2023
- Title:
- MCTC176 Form | eSIF Filing Index for IITs
- Topic:
- Records Software Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 28/02/2023
- Title:
- MCTC173 Form | eISF Filing Index for IITs
- Topic:
- Records Software Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 28/02/2023
- Title:
- MCTC007 Form | MCRI Sponsorship Application & Risk Matrix
- Topic:
- Sponsorship
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Form
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 13/01/2020
- Title:
- MCTC183 SOP | Delegation of Sponsor Responsibilities in MCRI-Sponsored IITs
- Topic:
- Sponsorship
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 06/04/2023
- Title:
- MCTC037b SOP | MCRI Sponsorship Application Process for IITs
- Topic:
- Sponsorship
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 27/06/2023
- Title:
- MCTC182 SOP | Sponsor-Investigator Responsibilities in MCRI-Sponsored IITs
- Topic:
- Sponsorship Staff
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 06/04/2023
- Title:
- MCTC168 Form | Roles and Responsibilities Matrix
- Topic:
- Sponsorship Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Form
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 06/04/2023
- Title:
- MCTC083 Terms of Reference | MCRI Sponsorship Committee
- Topic:
- Sponsorship
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Policy
- Author:
- Iona Walton (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 20/12/2024
- Title:
- MCTC180 Form | Protocol Approval Form
- Topic:
- Protocol Approvals
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 21/03/2023
- Title:
- MCTC179 Form | PICF Approval Form
- Topic:
- Approvals Consent Recruitment
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Form
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 21/03/2023
- Title:
- MCTC048 SOP | Submitting and updating a CTN to the TGA
- Topic:
- Reporting Governance Other
- Applicability:
- Intervention: drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Kate Scarff (CRDO Lead)
- Version #:
- 1.0
- Date of Publication:
- 21/03/2023
- Title:
- MCTC164 SOP | Management of Temperature Controlled Storage
- Topic:
- Equipment Other
- Applicability:
- Intervention: drug/device
- Department:
- Melbourne Children's Trials Centre Clinical Research
- Function:
- Standard Operating Procedure
- Author:
- Carolyn Stewart (MCTC Business and Operations Manager)
- Version #:
- 1.0
- Date of Publication:
- 18/04/2023
- Title:
- CEBU | REDCap Project User Management for Trials
- Topic:
- Data Software
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Clinical Epidemiology & Biostatistics (CEBU)
- Function:
- Standard Operating Procedure
- Author:
- Luke Stevens (Research Data Systems Manager, CEBU)
- Version #:
- 1.0
- Date of Publication:
- 06/05/2022
- Title:
- CEBU | REDCap Project Change Controls for Trials
- Topic:
- Data Software
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Clinical Epidemiology & Biostatistics (CEBU)
- Function:
- Standard Operating Procedure
- Author:
- Luke Stevens (Research Data Systems Manager, CEBU)
- Version #:
- 1.0
- Date of Publication:
- 06/05/2022
- Title:
- MCTC054.01 Template | Sample Tracking and Processing Log
- Topic:
- Records Safety Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Bio-Banking Facility
- Function:
- Template
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 19/05/2023
- Title:
- MCTC166 SOP | Management of Investigational Product
- Topic:
- Equipment Other Safety
- Applicability:
- Intervention: drug/device
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Saranga Senanayake (Research Coordinator, MCTC)
- Version #:
- 1.0
- Date of Publication:
- 20/06/2023
- Title:
- MCTC185 Template | Remote Monitoring Visit Confirmation Letter
- Topic:
- Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- Laura Galletta (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 05/07/2023
- Title:
- MCTC186 Template | Remote Monitoring Visit Follow Up Letter
- Topic:
- Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- Laura Galletta (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 05/07/2023
- Title:
- MCTC032 SOP | Archiving in Florence eBinders
- Topic:
- Data Records Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 06/07/2023
- Title:
- MCTC189 SOP | Trial Close Out for Investigator-Initiated Trials (IITs)
- Topic:
- Reporting Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 14/10/2024
- Title:
- MCTC174 Form | Sponsorship Committee Final Report
- Topic:
- Sponsorship Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Form
- Author:
- Iona Walton (Project Officer)
- Version #:
- 1.0
- Date of Publication:
- 19/09/2023
- Title:
- MCTC187 Guidance | Clinical Trial Decision Tool
- Topic:
- Protocol Sponsorship Other Governance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Guidance
- Author:
- Laura Galletta & Kate Scarff (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 17/12/2024
- Title:
- MCTC195 Template | Data Management Plan (DMP)
- Topic:
- Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- Richard Hall (MCTC Data Officer)
- Version #:
- 2.0
- Date of Publication:
- 09/08/2024
- Title:
- MCTC200 Factsheet | Documentation of Key Personnel
- Topic:
- Records Staff
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Factsheet
- Author:
- Sarah Rathjen (CRDO Education and Training Coordinator)
- Version #:
- 1.0
- Date of Publication:
- 10/01/2024
- Title:
- MCTC165 SOP | Informed Consent in Clinical Trials
- Topic:
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 14/03/2024
- Title:
- Melbourne Children's DERP User Guide for Researchers
- Topic:
- Other Governance Ethics
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance
- Department:
- Function:
- Guidance
- Author:
- Research Ethics and Governance (REG RCH)
- Version #:
- 1.0
- Date of Publication:
- 12/02/2024
- Title:
- MCTC202 Template | Archiving Box Label
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 12/04/2024
- Title:
- MCTC203 Template | GRACE Archiving Log
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 12/04/2024
- Title:
- MCTC199 SOP | Internal Auditing
- Topic:
- Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Jenny Munro & Di Tucker (Research Governance Manager & NCTGF Project Manager)
- Version #:
- 1.0
- Date of Publication:
- 01/08/2024
- Title:
- MCTC206 Factsheet | MCTC IIT Program Services List
- Topic:
- Other Finance
- Applicability:
- Intervention: drug/device Other Observational Intervention: no drug/device
- Department:
- Function:
- Factsheet
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 09/02/2024
- Title:
- MCTC196 Factsheet | IIT Trial Budget Tips
- Topic:
- Finance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Factsheet
- Author:
- Laura Galletta (MCTC)
- Version #:
- 2.0
- Date of Publication:
- 09/08/2024
- Title:
- MCTC084 SOP | Trial Master File (TMF) Quality Assurance
- Topic:
- Records Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/12/2024
- Title:
- MCTC067 Form | Trial Master File (TMF) Quality Assurance (QA) Review Checklist
- Topic:
- Monitoring / QA Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 16/08/2024
- Title:
- MCTC066 Form | SIF QA Binder Review Checklist
- Topic:
- Monitoring / QA Records Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 16/08/2024
- Title:
- MCTC064 Form | TMF QA Review Planning Form
- Topic:
- Data Monitoring / QA Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 16/08/2024
- Title:
- MCTC216 Form | eCRF Data Review and Sign Off by PI
- Topic:
- Data Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Form
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 07/02/2025
- Title:
- MCTC071 Guidance | eInvestigator Site File Filing (eISF) for MCRI sponsored clinical trials
- Topic:
- Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Melbourne Children's Trials Centre
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.2
- Date of Publication:
- 01/12/2022
- Title:
- MCTC014 Guidance | Filing definitions and Principles
- Topic:
- Data Records Reporting Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.0
- Date of Publication:
- 02/03/2022
- Title:
- MCTC079 SOP | Data sharing and access procedure for the release of data from the Murdoch Children's sponsored investigator-initiated clinical trials
- Topic:
- Data Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Natalie Rose, Laura Galetta (CRDO, MCTC)
- Version #:
- 1.0
- Date of Publication:
- 20/10/2020
- Title:
- MCTC050 Guidance | Data and Safety Monitoring Boards (DSMB)
- Topic:
- Monitoring / QA Data Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 08/07/2021
- Title:
- MCTC051 Template | DSMB Charter
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 07/07/2021
- Title:
- MCTC137 Form | MCRI Sponsorship Committee Annual Progress Report
- Topic:
- Sponsorship
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Form
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 01/01/2022
- Title:
- MCTC038 Guidance | Setting up a research project budget
- Topic:
- Other Finance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 10/11/2016
- Title:
- MCTC036 Template | Budgets
- Topic:
- Other Finance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 18/05/2016
- Title:
- MCTC003 Guidance | Developing, amending and complying with research protocols
- Topic:
- Protocol
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 11/10/2017
- Title:
- MCTC059 Template | Melbourne Children's clinical trial (non-drug, non-biological, non-device intervention) protocol
- Topic:
- Protocol
- Applicability:
- Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO, CEBU (CRDO)
- Version #:
- 5.0
- Date of Publication:
- 02/09/2019
- Title:
- MCTC029 Template | Study/Trial Steering Committee (SSC/TSC) Charter
- Topic:
- Governance Protocol Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 22/09/2020
- Title:
- MCTC052 Template | DSMB Meeting Agenda
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC053 Template | DSMB Open Report
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC013 Guidance | Site Investigator File (SIF) Essential Document Filing
- Topic:
- Records
- Applicability:
- Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 02/06/2021
- Title:
- MCTC116 Template | SIF Paper binder section dividers
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC011 Guidance | Investigator Site File - Table of Contents Document Filing
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC118 Template | ISF Paper binder section dividers
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC117 Template | ISF Table of Contents
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC002 SOP | Copying and Certifying Essential Documents
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Natalie Rose (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 17/05/2018
- Title:
- MCTC106 Guidance | Principles of the General Data Protection Regulation (GDPR) & Data Protection in a Research Context
- Topic:
- Governance Reporting Data
- Applicability:
- Other Quality Assurance Intervention: no drug/device Intervention: drug/device Observational
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC107 Factsheet | GDPR Guidelines for Researchers: Information Sheet & Quick Facts
- Topic:
- Governance Reporting Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC170 SOP | Archiving Clinical Trial Investigator Site Files
- Topic:
- Data Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Angela Karandaglidis (Clinical Trial Assistant)
- Version #:
- 1.0
- Date of Publication:
- 12/04/2024
- Title:
- MCTC009 Form | Sample Protocol Feasibility Checklist
- Topic:
- Protocol
- Applicability:
- Intervention: no drug/device Intervention: drug/device
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 25/01/2023
- Title:
- MCTC049 Template | Study task timeline
- Topic:
- Other Approvals
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 12/04/2017
- Title:
- MCTC056 Form | Checklist for Trial development and Start-up
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 09/08/2021
- Title:
- MCTC016 Template | Notification of Site Activation
- Topic:
- Other Approvals Governance Protocol Reporting
- Applicability:
- Observational Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 04/01/2020
- Title:
- MCTC135 SOP | Establishing International Clinical Trials
- Topic:
- Other Governance Approvals
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 18/08/2021
- Title:
- MCTC139 SOP | Site Initiation for MCRI-Sponsored Clinical Trials
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 02/03/2022
- Title:
- MCTC139.01 Factsheet | Site Initiation for MCRI-Sponsored Trials
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Factsheet
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.1
- Date of Publication:
- 07/09/2021
- Title:
- MCTC122 Template | Site Initiation Booking Confirmation Letter
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.1
- Date of Publication:
- 23/08/2021
- Title:
- MCTC132 Template | Site Initiation Meeting Agenda
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: no drug/device Intervention: drug/device Observational
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 03/02/2022
- Title:
- MCTC140 Template | Essential document request letter prior to site initiation
- Topic:
- Approvals Governance Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC141 Template | Site Initiation Follow up Letter
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC142 Template | Site Initiation Follow up Report
- Topic:
- Approvals Governance Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC033 SOP | Regulatory Green Light Approval for Clinical Trial Site Activation
- Topic:
- Approvals Governance Other Protocol
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 08/09/2021
- Title:
- MCTC034 Template | Regulatory Green Light Approval Form
- Topic:
- Approvals Governance Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 08/09/2021
- Title:
- MCTC035 Template | Risk Assessment and Risk Management Tool for Clinical Trials
- Topic:
- Sponsorship Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- MCTC (MCTC)
- Version #:
- 2.0
- Date of Publication:
- 05/10/2020
- Title:
- MCTC061 SOP | Continuous improvement: A Corrective and Preventative Action (CAPA) Plan
- Topic:
- Safety Reporting Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC080 Template | CAPA Plan
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC081 Template | CAPA Tracking Log
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC008 Template | Expedited Safety Report Form
- Topic:
- Safety Reporting
- Applicability:
- Intervention: no drug/device Intervention: drug/device
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 18/03/2020
- Title:
- MCTC018 Template | Clinical Review of Safety Events
- Topic:
- Safety Reporting Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 29/07/2022
- Title:
- MCTC094 Process Map | Responsibilities of Site PIs in MCRI-sponsored IITs: Safety Assessment, Documentation and Reporting
- Topic:
- Safety Reporting Staff
- Applicability:
- Intervention: drug/device Observational Intervention: no drug/device
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 18/03/2020
- Title:
- MCTC095 Process Map | Responsibilities of the Sponsor-Investigator in MCRI-sponsored IITs: Safety Assessment, Documentation and Reporting
- Topic:
- Safety Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 18/03/2020
- Title:
- MCTC123 SOP | MCRI Sponsor-Investigator Management of Non-Compliance: Protocol Deviations and Serious Breaches
- Topic:
- Protocol Reporting Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Natalie Rose, Kate Scarff (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 24/03/2022
- Title:
- MCTC124 Form | Non-Compliance Report
- Topic:
- Reporting Protocol Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other Quality Assurance
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 28/03/2022
- Title:
- MCTC125 Form | Non-Compliance Review
- Topic:
- Reporting Protocol Safety Other Governance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 23/03/2022
- Title:
- MCTC127 Template | Site Non-Compliance Log
- Topic:
- Monitoring / QA Protocol Reporting Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 30/06/2021
- Title:
- MCTC126 Template | Central Non-Compliance Log
- Topic:
- Other Safety Reporting Protocol Governance
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 30/06/2021
- Title:
- MCTC128 Timeline | Non-Compliance Reporting
- Topic:
- Reporting Safety Protocol Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 23/03/2022
- Title:
- MCTC046 SOP | Monitoring Visit Activities for Clinical Trials of Investigational Products
- Topic:
- Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Kate Scarff (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 08/11/2018
- Title:
- MCTC047 Template | Clinical Monitoring Plan for IITs
- Topic:
- Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 01/05/2018
- Title:
- MCTC068 Template | Monitoring Visit Report
- Topic:
- Monitoring / QA Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 19/03/2020
- Title:
- MCTC093 Template | Participant-Level Monitoring Form for IITs
- Topic:
- Monitoring / QA Recruitment Reporting Other Consent Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 08/11/2018
- Title:
- MCTC072 Factsheet | Using Teams for Trial Monitoring
- Topic:
- Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC073 Factsheet | Access Parkville Connect for Trial Monitoring
- Topic:
- Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Factsheet
- Author:
- Iona Walton (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 21/10/2024
- Title:
- MCTC028 Template | Note to File
- Topic:
- Records Other Governance Monitoring / QA Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 4.0
- Date of Publication:
- 13/06/2023
- Title:
- MCTC042 SOP | Investigator's Brochure Content, Design, Amendments, Filing & Distribution
- Topic:
- Data Other Staff Sponsorship Records Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Fiona Williams (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 09/11/2017
- Title:
- MCTC043 Flowchart | Ethics & Governance Process for Stand Alone Sites
- Topic:
- Ethics Governance Other Approvals
- Applicability:
- Intervention: no drug/device Observational Intervention: drug/device Other
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 11/10/2017
- Title:
- MCTC044 Flowchart | Ethics & Governance Process for Lead and Accepting Sites
- Topic:
- Approvals Ethics Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 10/10/2017
- Title:
- MCTC069 Guidance | eTMF Filing Guideline
- Topic:
- Monitoring / QA Other Software Records Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 01/06/2021
- Title:
- MCTC070 Guidance | eSIF Filing Guidelines
- Topic:
- Data Monitoring / QA Records Other Software
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 01/06/2021
- Title:
- MCTC099 Form | Wet Ink Signature Page
- Topic:
- Software Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- Iona Walton (CRDO)
- Version #:
- 2.1
- Date of Publication:
- 07/03/2024
- Title:
- MCTC104 Guidance | eISF Workflows and eSignature Reference Guide for IITs
- Topic:
- Software Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 03/12/2020
- Title:
- MCTC105 Guidance | eTMF Workflows and eSignature Reference Guide for IITs
- Topic:
- Software Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 03/12/2020
- Title:
- MCTC108 Template | Data Protection Checklist
- Topic:
- Approvals Consent Ethics Data Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Template
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC065 SOP | Study Start up for Clinical Trials
- Topic:
- Approvals Governance Other Records Ethics Monitoring / QA Protocol
- Applicability:
- Intervention: drug/device Observational Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 2.0
- Date of Publication:
- 05/04/2023
- Title:
- MCTC177 Form | eTMF Filing Index for IITs
- Topic:
- Records Other Software
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 28/02/2023
- Title:
- MCTC176 Form | eSIF Filing Index for IITs
- Topic:
- Records Software Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 28/02/2023
- Title:
- MCTC173 Form | eISF Filing Index for IITs
- Topic:
- Records Software Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 28/02/2023
- Title:
- MCTC007 Form | MCRI Sponsorship Application & Risk Matrix
- Topic:
- Sponsorship
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Form
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 13/01/2020
- Title:
- MCTC183 SOP | Delegation of Sponsor Responsibilities in MCRI-Sponsored IITs
- Topic:
- Sponsorship
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 06/04/2023
- Title:
- MCTC037b SOP | MCRI Sponsorship Application Process for IITs
- Topic:
- Sponsorship
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 27/06/2023
- Title:
- MCTC182 SOP | Sponsor-Investigator Responsibilities in MCRI-Sponsored IITs
- Topic:
- Sponsorship Staff
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 06/04/2023
- Title:
- MCTC168 Form | Roles and Responsibilities Matrix
- Topic:
- Sponsorship Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Form
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 06/04/2023
- Title:
- MCTC083 Terms of Reference | MCRI Sponsorship Committee
- Topic:
- Sponsorship
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Policy
- Author:
- Iona Walton (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 20/12/2024
- Title:
- MCTC180 Form | Protocol Approval Form
- Topic:
- Protocol Approvals
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 21/03/2023
- Title:
- MCTC179 Form | PICF Approval Form
- Topic:
- Approvals Consent Recruitment
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Form
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 21/03/2023
- Title:
- CEBU | REDCap Project User Management for Trials
- Topic:
- Data Software
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Clinical Epidemiology & Biostatistics (CEBU)
- Function:
- Standard Operating Procedure
- Author:
- Luke Stevens (Research Data Systems Manager, CEBU)
- Version #:
- 1.0
- Date of Publication:
- 06/05/2022
- Title:
- CEBU | REDCap Project Change Controls for Trials
- Topic:
- Data Software
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Clinical Epidemiology & Biostatistics (CEBU)
- Function:
- Standard Operating Procedure
- Author:
- Luke Stevens (Research Data Systems Manager, CEBU)
- Version #:
- 1.0
- Date of Publication:
- 06/05/2022
- Title:
- MCTC054.01 Template | Sample Tracking and Processing Log
- Topic:
- Records Safety Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Bio-Banking Facility
- Function:
- Template
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 19/05/2023
- Title:
- MCTC185 Template | Remote Monitoring Visit Confirmation Letter
- Topic:
- Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- Laura Galletta (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 05/07/2023
- Title:
- MCTC186 Template | Remote Monitoring Visit Follow Up Letter
- Topic:
- Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- Laura Galletta (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 05/07/2023
- Title:
- MCTC032 SOP | Archiving in Florence eBinders
- Topic:
- Data Records Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 06/07/2023
- Title:
- MCTC189 SOP | Trial Close Out for Investigator-Initiated Trials (IITs)
- Topic:
- Reporting Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 14/10/2024
- Title:
- MCTC174 Form | Sponsorship Committee Final Report
- Topic:
- Sponsorship Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Form
- Author:
- Iona Walton (Project Officer)
- Version #:
- 1.0
- Date of Publication:
- 19/09/2023
- Title:
- MCTC187 Guidance | Clinical Trial Decision Tool
- Topic:
- Protocol Sponsorship Other Governance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Guidance
- Author:
- Laura Galletta & Kate Scarff (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 17/12/2024
- Title:
- MCTC195 Template | Data Management Plan (DMP)
- Topic:
- Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- Richard Hall (MCTC Data Officer)
- Version #:
- 2.0
- Date of Publication:
- 09/08/2024
- Title:
- MCTC200 Factsheet | Documentation of Key Personnel
- Topic:
- Records Staff
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Factsheet
- Author:
- Sarah Rathjen (CRDO Education and Training Coordinator)
- Version #:
- 1.0
- Date of Publication:
- 10/01/2024
- Title:
- MCTC165 SOP | Informed Consent in Clinical Trials
- Topic:
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 14/03/2024
- Title:
- Melbourne Children's DERP User Guide for Researchers
- Topic:
- Other Governance Ethics
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance
- Department:
- Function:
- Guidance
- Author:
- Research Ethics and Governance (REG RCH)
- Version #:
- 1.0
- Date of Publication:
- 12/02/2024
- Title:
- MCTC202 Template | Archiving Box Label
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 12/04/2024
- Title:
- MCTC203 Template | GRACE Archiving Log
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 12/04/2024
- Title:
- MCTC199 SOP | Internal Auditing
- Topic:
- Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Jenny Munro & Di Tucker (Research Governance Manager & NCTGF Project Manager)
- Version #:
- 1.0
- Date of Publication:
- 01/08/2024
- Title:
- MCTC194a SOP | Trial-Specific Qualification, Education, and Training – Clinical Trials Team Members
- Topic:
- Records Staff Other
- Applicability:
- Intervention: no drug/device N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Sarah Rathjen (Project Officer – Education and Training Coordinator)
- Version #:
- 1.1
- Date of Publication:
- 22/11/2024
- Title:
- MCTC206 Factsheet | MCTC IIT Program Services List
- Topic:
- Other Finance
- Applicability:
- Intervention: drug/device Other Observational Intervention: no drug/device
- Department:
- Function:
- Factsheet
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 09/02/2024
- Title:
- MCTC196 Factsheet | IIT Trial Budget Tips
- Topic:
- Finance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Factsheet
- Author:
- Laura Galletta (MCTC)
- Version #:
- 2.0
- Date of Publication:
- 09/08/2024
- Title:
- MCTC084 SOP | Trial Master File (TMF) Quality Assurance
- Topic:
- Records Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/12/2024
- Title:
- MCTC067 Form | Trial Master File (TMF) Quality Assurance (QA) Review Checklist
- Topic:
- Monitoring / QA Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 16/08/2024
- Title:
- MCTC066 Form | SIF QA Binder Review Checklist
- Topic:
- Monitoring / QA Records Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 16/08/2024
- Title:
- MCTC064 Form | TMF QA Review Planning Form
- Topic:
- Data Monitoring / QA Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 16/08/2024
- Title:
- MCTC216 Form | eCRF Data Review and Sign Off by PI
- Topic:
- Data Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Form
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 07/02/2025
- Title:
- MCTC071 Guidance | eInvestigator Site File Filing (eISF) for MCRI sponsored clinical trials
- Topic:
- Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Melbourne Children's Trials Centre
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.2
- Date of Publication:
- 01/12/2022
- Title:
- MCTC014 Guidance | Filing definitions and Principles
- Topic:
- Data Records Reporting Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.0
- Date of Publication:
- 02/03/2022
- Title:
- MCTC050 Guidance | Data and Safety Monitoring Boards (DSMB)
- Topic:
- Monitoring / QA Data Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 08/07/2021
- Title:
- MCTC003 Guidance | Developing, amending and complying with research protocols
- Topic:
- Protocol
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 11/10/2017
- Title:
- MCTC060 Template | Melbourne Children's observational studies protocol
- Topic:
- Protocol
- Applicability:
- Observational
- Department:
- Function:
- Template
- Author:
- CRDO, CEBU (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 04/06/2019
- Title:
- MCTC029 Template | Study/Trial Steering Committee (SSC/TSC) Charter
- Topic:
- Governance Protocol Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 22/09/2020
- Title:
- MCTC052 Template | DSMB Meeting Agenda
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC053 Template | DSMB Open Report
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC002 SOP | Copying and Certifying Essential Documents
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Natalie Rose (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 17/05/2018
- Title:
- MCTC106 Guidance | Principles of the General Data Protection Regulation (GDPR) & Data Protection in a Research Context
- Topic:
- Governance Reporting Data
- Applicability:
- Other Quality Assurance Intervention: no drug/device Intervention: drug/device Observational
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC107 Factsheet | GDPR Guidelines for Researchers: Information Sheet & Quick Facts
- Topic:
- Governance Reporting Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC170 SOP | Archiving Clinical Trial Investigator Site Files
- Topic:
- Data Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Angela Karandaglidis (Clinical Trial Assistant)
- Version #:
- 1.0
- Date of Publication:
- 12/04/2024
- Title:
- MCTC049 Template | Study task timeline
- Topic:
- Other Approvals
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 12/04/2017
- Title:
- MCTC056 Form | Checklist for Trial development and Start-up
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 09/08/2021
- Title:
- MCTC016 Template | Notification of Site Activation
- Topic:
- Other Approvals Governance Protocol Reporting
- Applicability:
- Observational Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 04/01/2020
- Title:
- MCTC139 SOP | Site Initiation for MCRI-Sponsored Clinical Trials
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 02/03/2022
- Title:
- MCTC139.01 Factsheet | Site Initiation for MCRI-Sponsored Trials
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Factsheet
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.1
- Date of Publication:
- 07/09/2021
- Title:
- MCTC122 Template | Site Initiation Booking Confirmation Letter
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.1
- Date of Publication:
- 23/08/2021
- Title:
- MCTC132 Template | Site Initiation Meeting Agenda
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: no drug/device Intervention: drug/device Observational
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 03/02/2022
- Title:
- MCTC141 Template | Site Initiation Follow up Letter
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC142 Template | Site Initiation Follow up Report
- Topic:
- Approvals Governance Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC061 SOP | Continuous improvement: A Corrective and Preventative Action (CAPA) Plan
- Topic:
- Safety Reporting Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC094 Process Map | Responsibilities of Site PIs in MCRI-sponsored IITs: Safety Assessment, Documentation and Reporting
- Topic:
- Safety Reporting Staff
- Applicability:
- Intervention: drug/device Observational Intervention: no drug/device
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 18/03/2020
- Title:
- MCTC095 Process Map | Responsibilities of the Sponsor-Investigator in MCRI-sponsored IITs: Safety Assessment, Documentation and Reporting
- Topic:
- Safety Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 18/03/2020
- Title:
- MCTC123 SOP | MCRI Sponsor-Investigator Management of Non-Compliance: Protocol Deviations and Serious Breaches
- Topic:
- Protocol Reporting Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Natalie Rose, Kate Scarff (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 24/03/2022
- Title:
- MCTC124 Form | Non-Compliance Report
- Topic:
- Reporting Protocol Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other Quality Assurance
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 28/03/2022
- Title:
- MCTC125 Form | Non-Compliance Review
- Topic:
- Reporting Protocol Safety Other Governance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 23/03/2022
- Title:
- MCTC043 Flowchart | Ethics & Governance Process for Stand Alone Sites
- Topic:
- Ethics Governance Other Approvals
- Applicability:
- Intervention: no drug/device Observational Intervention: drug/device Other
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 11/10/2017
- Title:
- MCTC044 Flowchart | Ethics & Governance Process for Lead and Accepting Sites
- Topic:
- Approvals Ethics Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 10/10/2017
- Title:
- MCTC069 Guidance | eTMF Filing Guideline
- Topic:
- Monitoring / QA Other Software Records Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 01/06/2021
- Title:
- MCTC070 Guidance | eSIF Filing Guidelines
- Topic:
- Data Monitoring / QA Records Other Software
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 01/06/2021
- Title:
- MCTC099 Form | Wet Ink Signature Page
- Topic:
- Software Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- Iona Walton (CRDO)
- Version #:
- 2.1
- Date of Publication:
- 07/03/2024
- Title:
- MCTC104 Guidance | eISF Workflows and eSignature Reference Guide for IITs
- Topic:
- Software Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 03/12/2020
- Title:
- MCTC105 Guidance | eTMF Workflows and eSignature Reference Guide for IITs
- Topic:
- Software Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 03/12/2020
- Title:
- MCTC108 Template | Data Protection Checklist
- Topic:
- Approvals Consent Ethics Data Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Template
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC065 SOP | Study Start up for Clinical Trials
- Topic:
- Approvals Governance Other Records Ethics Monitoring / QA Protocol
- Applicability:
- Intervention: drug/device Observational Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 2.0
- Date of Publication:
- 05/04/2023
- Title:
- MCTC177 Form | eTMF Filing Index for IITs
- Topic:
- Records Other Software
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 28/02/2023
- Title:
- MCTC176 Form | eSIF Filing Index for IITs
- Topic:
- Records Software Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 28/02/2023
- Title:
- MCTC173 Form | eISF Filing Index for IITs
- Topic:
- Records Software Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 28/02/2023
- Title:
- MCTC007 Form | MCRI Sponsorship Application & Risk Matrix
- Topic:
- Sponsorship
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Form
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 13/01/2020
- Title:
- MCTC183 SOP | Delegation of Sponsor Responsibilities in MCRI-Sponsored IITs
- Topic:
- Sponsorship
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 06/04/2023
- Title:
- MCTC083 Terms of Reference | MCRI Sponsorship Committee
- Topic:
- Sponsorship
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Policy
- Author:
- Iona Walton (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 20/12/2024
- Title:
- CEBU | REDCap Project User Management for Trials
- Topic:
- Data Software
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Clinical Epidemiology & Biostatistics (CEBU)
- Function:
- Standard Operating Procedure
- Author:
- Luke Stevens (Research Data Systems Manager, CEBU)
- Version #:
- 1.0
- Date of Publication:
- 06/05/2022
- Title:
- CEBU | REDCap Project Change Controls for Trials
- Topic:
- Data Software
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Clinical Epidemiology & Biostatistics (CEBU)
- Function:
- Standard Operating Procedure
- Author:
- Luke Stevens (Research Data Systems Manager, CEBU)
- Version #:
- 1.0
- Date of Publication:
- 06/05/2022
- Title:
- MCTC054.01 Template | Sample Tracking and Processing Log
- Topic:
- Records Safety Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Bio-Banking Facility
- Function:
- Template
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 19/05/2023
- Title:
- MCTC032 SOP | Archiving in Florence eBinders
- Topic:
- Data Records Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 06/07/2023
- Title:
- MCTC187 Guidance | Clinical Trial Decision Tool
- Topic:
- Protocol Sponsorship Other Governance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Guidance
- Author:
- Laura Galletta & Kate Scarff (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 17/12/2024
- Title:
- MCTC200 Factsheet | Documentation of Key Personnel
- Topic:
- Records Staff
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Factsheet
- Author:
- Sarah Rathjen (CRDO Education and Training Coordinator)
- Version #:
- 1.0
- Date of Publication:
- 10/01/2024
- Title:
- Melbourne Children's DERP User Guide for Researchers
- Topic:
- Other Governance Ethics
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance
- Department:
- Function:
- Guidance
- Author:
- Research Ethics and Governance (REG RCH)
- Version #:
- 1.0
- Date of Publication:
- 12/02/2024
- Title:
- MCTC199 SOP | Internal Auditing
- Topic:
- Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Jenny Munro & Di Tucker (Research Governance Manager & NCTGF Project Manager)
- Version #:
- 1.0
- Date of Publication:
- 01/08/2024
- Title:
- MCTC206 Factsheet | MCTC IIT Program Services List
- Topic:
- Other Finance
- Applicability:
- Intervention: drug/device Other Observational Intervention: no drug/device
- Department:
- Function:
- Factsheet
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 09/02/2024
- Title:
- MCTC066 Form | SIF QA Binder Review Checklist
- Topic:
- Monitoring / QA Records Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 16/08/2024
- Title:
- MCTC064 Form | TMF QA Review Planning Form
- Topic:
- Data Monitoring / QA Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 16/08/2024
- Title:
- Qualitative Research Community of Practice Terms of Reference
- Topic:
- Other
- Applicability:
- Qualitative
- Department:
- Function:
- Policy
- Author:
- Kate Paton (QRCoP Lead)
- Version #:
- 2.0
- Date of Publication:
- 26/07/2023
- Title:
- MCTC191 Factsheet | Qualitative Research Virtual Focus Groups and Interviews
- Topic:
- Other
- Applicability:
- Qualitative
- Department:
- Function:
- Factsheet
- Author:
- Kate Paton (QRCoP)
- Version #:
- 1.0
- Date of Publication:
- 17/10/2023
- Title:
- MCTC071 Guidance | eInvestigator Site File Filing (eISF) for MCRI sponsored clinical trials
- Topic:
- Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Melbourne Children's Trials Centre
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.2
- Date of Publication:
- 01/12/2022
- Title:
- MCTC014 Guidance | Filing definitions and Principles
- Topic:
- Data Records Reporting Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.0
- Date of Publication:
- 02/03/2022
- Title:
- MCTC050 Guidance | Data and Safety Monitoring Boards (DSMB)
- Topic:
- Monitoring / QA Data Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 08/07/2021
- Title:
- MCTC002 SOP | Copying and Certifying Essential Documents
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Natalie Rose (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 17/05/2018
- Title:
- MCTC106 Guidance | Principles of the General Data Protection Regulation (GDPR) & Data Protection in a Research Context
- Topic:
- Governance Reporting Data
- Applicability:
- Other Quality Assurance Intervention: no drug/device Intervention: drug/device Observational
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC107 Factsheet | GDPR Guidelines for Researchers: Information Sheet & Quick Facts
- Topic:
- Governance Reporting Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC124 Form | Non-Compliance Report
- Topic:
- Reporting Protocol Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other Quality Assurance
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 28/03/2022
- Title:
- MCTC054.01 Template | Sample Tracking and Processing Log
- Topic:
- Records Safety Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Bio-Banking Facility
- Function:
- Template
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 19/05/2023
- Title:
- Melbourne Children's DERP User Guide for Researchers
- Topic:
- Other Governance Ethics
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance
- Department:
- Function:
- Guidance
- Author:
- Research Ethics and Governance (REG RCH)
- Version #:
- 1.0
- Date of Publication:
- 12/02/2024
- Title:
- MCTC071 Guidance | eInvestigator Site File Filing (eISF) for MCRI sponsored clinical trials
- Topic:
- Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Melbourne Children's Trials Centre
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.2
- Date of Publication:
- 01/12/2022
- Title:
- MCTC014 Guidance | Filing definitions and Principles
- Topic:
- Data Records Reporting Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.0
- Date of Publication:
- 02/03/2022
- Title:
- MCTC050 Guidance | Data and Safety Monitoring Boards (DSMB)
- Topic:
- Monitoring / QA Data Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 08/07/2021
- Title:
- MCTC051 Template | DSMB Charter
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 07/07/2021
- Title:
- MCTC038 Guidance | Setting up a research project budget
- Topic:
- Other Finance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 10/11/2016
- Title:
- MCTC036 Template | Budgets
- Topic:
- Other Finance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 18/05/2016
- Title:
- MCTC003 Guidance | Developing, amending and complying with research protocols
- Topic:
- Protocol
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 11/10/2017
- Title:
- MCTC029 Template | Study/Trial Steering Committee (SSC/TSC) Charter
- Topic:
- Governance Protocol Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 22/09/2020
- Title:
- MCTC052 Template | DSMB Meeting Agenda
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC053 Template | DSMB Open Report
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC045 Workflow | Clinical Trial Contracts, Indemnities and Clinical Trial Notification Process Map
- Topic:
- Governance Approvals Reporting Other
- Applicability:
- Intervention: drug/device Other
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 19/12/2017
- Title:
- MCTC027 Form | Certificate of Sponsorship
- Topic:
- Sponsorship
- Applicability:
- Intervention: drug/device Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 24/03/2020
- Title:
- MCTC026 SOP | Clinical Trial Registration of Investigator-Initiated Trials (IITs)
- Topic:
- Governance Reporting Other
- Applicability:
- Intervention: drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.2
- Date of Publication:
- 04/07/2024
- Title:
- MCTC013 Guidance | Site Investigator File (SIF) Essential Document Filing
- Topic:
- Records
- Applicability:
- Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 02/06/2021
- Title:
- MCTC116 Template | SIF Paper binder section dividers
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC011 Guidance | Investigator Site File - Table of Contents Document Filing
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC118 Template | ISF Paper binder section dividers
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC117 Template | ISF Table of Contents
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC002 SOP | Copying and Certifying Essential Documents
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Natalie Rose (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 17/05/2018
- Title:
- MCTC106 Guidance | Principles of the General Data Protection Regulation (GDPR) & Data Protection in a Research Context
- Topic:
- Governance Reporting Data
- Applicability:
- Other Quality Assurance Intervention: no drug/device Intervention: drug/device Observational
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC107 Factsheet | GDPR Guidelines for Researchers: Information Sheet & Quick Facts
- Topic:
- Governance Reporting Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC170 SOP | Archiving Clinical Trial Investigator Site Files
- Topic:
- Data Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Angela Karandaglidis (Clinical Trial Assistant)
- Version #:
- 1.0
- Date of Publication:
- 12/04/2024
- Title:
- MCTC056 Form | Checklist for Trial development and Start-up
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 09/08/2021
- Title:
- MCTC016 Template | Notification of Site Activation
- Topic:
- Other Approvals Governance Protocol Reporting
- Applicability:
- Observational Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 04/01/2020
- Title:
- MCTC140 Template | Essential document request letter prior to site initiation
- Topic:
- Approvals Governance Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC141 Template | Site Initiation Follow up Letter
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC142 Template | Site Initiation Follow up Report
- Topic:
- Approvals Governance Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC033 SOP | Regulatory Green Light Approval for Clinical Trial Site Activation
- Topic:
- Approvals Governance Other Protocol
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 08/09/2021
- Title:
- MCTC061 SOP | Continuous improvement: A Corrective and Preventative Action (CAPA) Plan
- Topic:
- Safety Reporting Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC080 Template | CAPA Plan
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC081 Template | CAPA Tracking Log
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC123 SOP | MCRI Sponsor-Investigator Management of Non-Compliance: Protocol Deviations and Serious Breaches
- Topic:
- Protocol Reporting Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Natalie Rose, Kate Scarff (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 24/03/2022
- Title:
- MCTC124 Form | Non-Compliance Report
- Topic:
- Reporting Protocol Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other Quality Assurance
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 28/03/2022
- Title:
- MCTC125 Form | Non-Compliance Review
- Topic:
- Reporting Protocol Safety Other Governance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 23/03/2022
- Title:
- MCTC068 Template | Monitoring Visit Report
- Topic:
- Monitoring / QA Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 19/03/2020
- Title:
- MCTC042 SOP | Investigator's Brochure Content, Design, Amendments, Filing & Distribution
- Topic:
- Data Other Staff Sponsorship Records Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Fiona Williams (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 09/11/2017
- Title:
- MCTC043 Flowchart | Ethics & Governance Process for Stand Alone Sites
- Topic:
- Ethics Governance Other Approvals
- Applicability:
- Intervention: no drug/device Observational Intervention: drug/device Other
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 11/10/2017
- Title:
- MCTC044 Flowchart | Ethics & Governance Process for Lead and Accepting Sites
- Topic:
- Approvals Ethics Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 10/10/2017
- Title:
- MCTC069 Guidance | eTMF Filing Guideline
- Topic:
- Monitoring / QA Other Software Records Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 01/06/2021
- Title:
- MCTC070 Guidance | eSIF Filing Guidelines
- Topic:
- Data Monitoring / QA Records Other Software
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 01/06/2021
- Title:
- MCTC099 Form | Wet Ink Signature Page
- Topic:
- Software Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- Iona Walton (CRDO)
- Version #:
- 2.1
- Date of Publication:
- 07/03/2024
- Title:
- MCTC104 Guidance | eISF Workflows and eSignature Reference Guide for IITs
- Topic:
- Software Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 03/12/2020
- Title:
- MCTC105 Guidance | eTMF Workflows and eSignature Reference Guide for IITs
- Topic:
- Software Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 03/12/2020
- Title:
- MCTC065 SOP | Study Start up for Clinical Trials
- Topic:
- Approvals Governance Other Records Ethics Monitoring / QA Protocol
- Applicability:
- Intervention: drug/device Observational Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 2.0
- Date of Publication:
- 05/04/2023
- Title:
- MCTC172 Factsheet | CAAA IATA Shippers Training Course Booking Process
- Topic:
- Safety Staff Other Equipment
- Applicability:
- Intervention: drug/device Other
- Department:
- Function:
- Factsheet
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 06/02/2023
- Title:
- MCTC177 Form | eTMF Filing Index for IITs
- Topic:
- Records Other Software
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 28/02/2023
- Title:
- MCTC176 Form | eSIF Filing Index for IITs
- Topic:
- Records Software Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 28/02/2023
- Title:
- MCTC173 Form | eISF Filing Index for IITs
- Topic:
- Records Software Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 28/02/2023
- Title:
- MCTC007 Form | MCRI Sponsorship Application & Risk Matrix
- Topic:
- Sponsorship
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Form
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 13/01/2020
- Title:
- MCTC183 SOP | Delegation of Sponsor Responsibilities in MCRI-Sponsored IITs
- Topic:
- Sponsorship
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 06/04/2023
- Title:
- MCTC037b SOP | MCRI Sponsorship Application Process for IITs
- Topic:
- Sponsorship
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 27/06/2023
- Title:
- MCTC182 SOP | Sponsor-Investigator Responsibilities in MCRI-Sponsored IITs
- Topic:
- Sponsorship Staff
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 06/04/2023
- Title:
- MCTC168 Form | Roles and Responsibilities Matrix
- Topic:
- Sponsorship Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Form
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 06/04/2023
- Title:
- MCTC083 Terms of Reference | MCRI Sponsorship Committee
- Topic:
- Sponsorship
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Policy
- Author:
- Iona Walton (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 20/12/2024
- Title:
- MCTC048 SOP | Submitting and updating a CTN to the TGA
- Topic:
- Reporting Governance Other
- Applicability:
- Intervention: drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Kate Scarff (CRDO Lead)
- Version #:
- 1.0
- Date of Publication:
- 21/03/2023
- Title:
- CEBU | REDCap Project Change Controls for Trials
- Topic:
- Data Software
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Clinical Epidemiology & Biostatistics (CEBU)
- Function:
- Standard Operating Procedure
- Author:
- Luke Stevens (Research Data Systems Manager, CEBU)
- Version #:
- 1.0
- Date of Publication:
- 06/05/2022
- Title:
- MCTC054.01 Template | Sample Tracking and Processing Log
- Topic:
- Records Safety Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Bio-Banking Facility
- Function:
- Template
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 19/05/2023
- Title:
- MCTC185 Template | Remote Monitoring Visit Confirmation Letter
- Topic:
- Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- Laura Galletta (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 05/07/2023
- Title:
- MCTC186 Template | Remote Monitoring Visit Follow Up Letter
- Topic:
- Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- Laura Galletta (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 05/07/2023
- Title:
- MCTC032 SOP | Archiving in Florence eBinders
- Topic:
- Data Records Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 06/07/2023
- Title:
- MCTC189 SOP | Trial Close Out for Investigator-Initiated Trials (IITs)
- Topic:
- Reporting Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 14/10/2024
- Title:
- MCTC200 Factsheet | Documentation of Key Personnel
- Topic:
- Records Staff
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Factsheet
- Author:
- Sarah Rathjen (CRDO Education and Training Coordinator)
- Version #:
- 1.0
- Date of Publication:
- 10/01/2024
- Title:
- MCTC206 Factsheet | MCTC IIT Program Services List
- Topic:
- Other Finance
- Applicability:
- Intervention: drug/device Other Observational Intervention: no drug/device
- Department:
- Function:
- Factsheet
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 09/02/2024
- Title:
- MCTC196 Factsheet | IIT Trial Budget Tips
- Topic:
- Finance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Factsheet
- Author:
- Laura Galletta (MCTC)
- Version #:
- 2.0
- Date of Publication:
- 09/08/2024
- Title:
- MCTC084 SOP | Trial Master File (TMF) Quality Assurance
- Topic:
- Records Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/12/2024
- Title:
- MCTC067 Form | Trial Master File (TMF) Quality Assurance (QA) Review Checklist
- Topic:
- Monitoring / QA Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 16/08/2024
- Title:
- MCTC064 Form | TMF QA Review Planning Form
- Topic:
- Data Monitoring / QA Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 16/08/2024
- Title:
- MCTC014 Guidance | Filing definitions and Principles
- Topic:
- Data Records Reporting Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.0
- Date of Publication:
- 02/03/2022
- Title:
- MCTC002 SOP | Copying and Certifying Essential Documents
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Natalie Rose (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 17/05/2018
- Title:
- MCTC136 Template | Site Initiation Attendance Log
- Topic:
- Approvals Governance Other
- Applicability:
- N/A
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 03/02/2022
- Title:
- MCTC039 Template | Study Level Close Out Visit Report and Checklist
- Topic:
- Reporting Records Other
- Applicability:
- N/A
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 3.0
- Date of Publication:
- 04/10/2024
- Title:
- MCTC089 Form | Data access application
- Topic:
- Data Consent Sponsorship
- Applicability:
- N/A
- Department:
- Function:
- Form
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 11/09/2020
- Title:
- MCTC090 Form | Transfer of Data
- Topic:
- Sponsorship Data Records
- Applicability:
- N/A
- Department:
- Function:
- Form
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 11/09/2020
- Title:
- MCTC092 Form | Data Request Review
- Topic:
- Sponsorship Data Monitoring / QA Records Other
- Applicability:
- N/A
- Department:
- Function:
- Form
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 11/09/2020
- Title:
- MCTC091 Form | Data Sharing Plan
- Topic:
- Data Other Sponsorship Records
- Applicability:
- N/A
- Department:
- Function:
- Form
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 11/09/2020
- Title:
- MCTC061 SOP | Continuous improvement: A Corrective and Preventative Action (CAPA) Plan
- Topic:
- Safety Reporting Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC080 Template | CAPA Plan
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC081 Template | CAPA Tracking Log
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC102 SOP | Florence eBinders Management for IITs
- Topic:
- Software Other Data
- Applicability:
- N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 07/12/2020
- Title:
- MCTC194a SOP | Trial-Specific Qualification, Education, and Training – Clinical Trials Team Members
- Topic:
- Records Staff Other
- Applicability:
- Intervention: no drug/device N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Sarah Rathjen (Project Officer – Education and Training Coordinator)
- Version #:
- 1.1
- Date of Publication:
- 22/11/2024
- Title:
- MCTC209 Template | Close Out Visit (COV) Confirmation Letter
- Topic:
- Records Reporting Other
- Applicability:
- N/A
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 04/10/2024
- Title:
- MCTC210 Template | Close out Visit (COV) Follow Up Letter
- Topic:
- Records Reporting Other
- Applicability:
- N/A
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 04/10/2024
- Title:
- MCTC211 Template | Final Site Close Out Letter
- Topic:
- Records Reporting Other
- Applicability:
- N/A
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 04/10/2024
- Title:
- MCTC207 Template | Site Level Close Out Visit Report and Checklist
- Topic:
- Records Other
- Applicability:
- N/A
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 04/10/2024
- Title:
- MCTC071 Guidance | eInvestigator Site File Filing (eISF) for MCRI sponsored clinical trials
- Topic:
- Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Melbourne Children's Trials Centre
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.2
- Date of Publication:
- 01/12/2022
- Title:
- MCTC014 Guidance | Filing definitions and Principles
- Topic:
- Data Records Reporting Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.0
- Date of Publication:
- 02/03/2022
- Title:
- MCTC050 Guidance | Data and Safety Monitoring Boards (DSMB)
- Topic:
- Monitoring / QA Data Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 08/07/2021
- Title:
- MCTC051 Template | DSMB Charter
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 07/07/2021
- Title:
- MCTC038 Guidance | Setting up a research project budget
- Topic:
- Other Finance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 10/11/2016
- Title:
- MCTC036 Template | Budgets
- Topic:
- Other Finance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 18/05/2016
- Title:
- MCTC003 Guidance | Developing, amending and complying with research protocols
- Topic:
- Protocol
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 11/10/2017
- Title:
- MCTC029 Template | Study/Trial Steering Committee (SSC/TSC) Charter
- Topic:
- Governance Protocol Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 22/09/2020
- Title:
- MCTC052 Template | DSMB Meeting Agenda
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC053 Template | DSMB Open Report
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC045 Workflow | Clinical Trial Contracts, Indemnities and Clinical Trial Notification Process Map
- Topic:
- Governance Approvals Reporting Other
- Applicability:
- Intervention: drug/device Other
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 19/12/2017
- Title:
- MCTC011 Guidance | Investigator Site File - Table of Contents Document Filing
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC118 Template | ISF Paper binder section dividers
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC117 Template | ISF Table of Contents
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC106 Guidance | Principles of the General Data Protection Regulation (GDPR) & Data Protection in a Research Context
- Topic:
- Governance Reporting Data
- Applicability:
- Other Quality Assurance Intervention: no drug/device Intervention: drug/device Observational
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC107 Factsheet | GDPR Guidelines for Researchers: Information Sheet & Quick Facts
- Topic:
- Governance Reporting Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC009 Form | Sample Protocol Feasibility Checklist
- Topic:
- Protocol
- Applicability:
- Intervention: no drug/device Intervention: drug/device
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 25/01/2023
- Title:
- MCTC049 Template | Study task timeline
- Topic:
- Other Approvals
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 12/04/2017
- Title:
- MCTC016 Template | Notification of Site Activation
- Topic:
- Other Approvals Governance Protocol Reporting
- Applicability:
- Observational Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 04/01/2020
- Title:
- MCTC122 Template | Site Initiation Booking Confirmation Letter
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.1
- Date of Publication:
- 23/08/2021
- Title:
- MCTC132 Template | Site Initiation Meeting Agenda
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: no drug/device Intervention: drug/device Observational
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 03/02/2022
- Title:
- MCTC140 Template | Essential document request letter prior to site initiation
- Topic:
- Approvals Governance Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC141 Template | Site Initiation Follow up Letter
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC142 Template | Site Initiation Follow up Report
- Topic:
- Approvals Governance Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC054 SOP | Handling, Processing, Storage and Transport of Biospecimens in Human Research
- Topic:
- Safety Staff Equipment Other
- Applicability:
- Intervention: no drug/device Intervention: drug/device Other Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Saranga Senanayake (Research Coordinator, MCTC)
- Version #:
- 2.0
- Date of Publication:
- 19/05/2023
- Title:
- MCTC061 SOP | Continuous improvement: A Corrective and Preventative Action (CAPA) Plan
- Topic:
- Safety Reporting Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC080 Template | CAPA Plan
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC081 Template | CAPA Tracking Log
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC008 Template | Expedited Safety Report Form
- Topic:
- Safety Reporting
- Applicability:
- Intervention: no drug/device Intervention: drug/device
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 18/03/2020
- Title:
- MCTC018 Template | Clinical Review of Safety Events
- Topic:
- Safety Reporting Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 29/07/2022
- Title:
- MCTC096 Timeline | Safety Reporting Timelines: Studies with Investigational Medicinal Products (IMPs)
- Topic:
- Safety Reporting
- Applicability:
- Intervention: drug/device
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/03/2020
- Title:
- MCTC097 Timeline | Safety Reporting Timelines: Studies with Investigational Medical Devices (IMDs)
- Topic:
- Safety Reporting
- Applicability:
- Intervention: drug/device
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/03/2020
- Title:
- MCTC112 SOP | MCRI/RCH Site Principal Investigator Management of Non-Compliance: Protocol Deviations and Serious Breaches
- Topic:
- Reporting Protocol Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Natalie Rose, Kate Scarff (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 24/03/2022
- Title:
- MCTC109 Form | Third Party Suspected Breach Report
- Topic:
- Protocol Reporting Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other Quality Assurance
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 01/07/2021
- Title:
- MCTC125 Form | Non-Compliance Review
- Topic:
- Reporting Protocol Safety Other Governance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 23/03/2022
- Title:
- MCTC127 Template | Site Non-Compliance Log
- Topic:
- Monitoring / QA Protocol Reporting Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 30/06/2021
- Title:
- MCTC126 Template | Central Non-Compliance Log
- Topic:
- Other Safety Reporting Protocol Governance
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 30/06/2021
- Title:
- MCTC128 Timeline | Non-Compliance Reporting
- Topic:
- Reporting Safety Protocol Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 23/03/2022
- Title:
- MCTC047 Template | Clinical Monitoring Plan for IITs
- Topic:
- Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 01/05/2018
- Title:
- MCTC072 Factsheet | Using Teams for Trial Monitoring
- Topic:
- Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC073 Factsheet | Access Parkville Connect for Trial Monitoring
- Topic:
- Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Factsheet
- Author:
- Iona Walton (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 21/10/2024
- Title:
- MCTC028 Template | Note to File
- Topic:
- Records Other Governance Monitoring / QA Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 4.0
- Date of Publication:
- 13/06/2023
- Title:
- MCTC044 Flowchart | Ethics & Governance Process for Lead and Accepting Sites
- Topic:
- Approvals Ethics Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 10/10/2017
- Title:
- MCTC099 Form | Wet Ink Signature Page
- Topic:
- Software Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- Iona Walton (CRDO)
- Version #:
- 2.1
- Date of Publication:
- 07/03/2024
- Title:
- MCTC101 SOP | Commercially Sponsored Florence eBinders Management
- Topic:
- Software Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 07/12/2020
- Title:
- MCTC103 Guidance | eISF Workflows and eSignature Reference Guide for Commercially Sponsored Studies
- Topic:
- Software Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- Iona Walton (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 10/01/2024
- Title:
- MCTC108 Template | Data Protection Checklist
- Topic:
- Approvals Consent Ethics Data Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Template
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC065 SOP | Study Start up for Clinical Trials
- Topic:
- Approvals Governance Other Records Ethics Monitoring / QA Protocol
- Applicability:
- Intervention: drug/device Observational Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 2.0
- Date of Publication:
- 05/04/2023
- Title:
- MCTC172 Factsheet | CAAA IATA Shippers Training Course Booking Process
- Topic:
- Safety Staff Other Equipment
- Applicability:
- Intervention: drug/device Other
- Department:
- Function:
- Factsheet
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 06/02/2023
- Title:
- MCTC180 Form | Protocol Approval Form
- Topic:
- Protocol Approvals
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 21/03/2023
- Title:
- MCTC179 Form | PICF Approval Form
- Topic:
- Approvals Consent Recruitment
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Form
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 21/03/2023
- Title:
- MCTC164 SOP | Management of Temperature Controlled Storage
- Topic:
- Equipment Other
- Applicability:
- Intervention: drug/device
- Department:
- Melbourne Children's Trials Centre Clinical Research
- Function:
- Standard Operating Procedure
- Author:
- Carolyn Stewart (MCTC Business and Operations Manager)
- Version #:
- 1.0
- Date of Publication:
- 18/04/2023
- Title:
- MCTC181 Guidance | CST ISF Table of Contents
- Topic:
- Records Other Data Sponsorship
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Guidance
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 09/03/2023
- Title:
- CEBU | REDCap Project User Management for Trials
- Topic:
- Data Software
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Clinical Epidemiology & Biostatistics (CEBU)
- Function:
- Standard Operating Procedure
- Author:
- Luke Stevens (Research Data Systems Manager, CEBU)
- Version #:
- 1.0
- Date of Publication:
- 06/05/2022
- Title:
- CEBU | REDCap Project Change Controls for Trials
- Topic:
- Data Software
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Clinical Epidemiology & Biostatistics (CEBU)
- Function:
- Standard Operating Procedure
- Author:
- Luke Stevens (Research Data Systems Manager, CEBU)
- Version #:
- 1.0
- Date of Publication:
- 06/05/2022
- Title:
- MCTC054.01 Template | Sample Tracking and Processing Log
- Topic:
- Records Safety Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Bio-Banking Facility
- Function:
- Template
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 19/05/2023
- Title:
- MCTC 019 Template | CST Recruitment Plan
- Topic:
- Recruitment
- Applicability:
- Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Template
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 01/06/2023
- Title:
- MCTC166 SOP | Management of Investigational Product
- Topic:
- Equipment Other Safety
- Applicability:
- Intervention: drug/device
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Saranga Senanayake (Research Coordinator, MCTC)
- Version #:
- 1.0
- Date of Publication:
- 20/06/2023
- Title:
- MCTC032 SOP | Archiving in Florence eBinders
- Topic:
- Data Records Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 06/07/2023
- Title:
- MCTC200 Factsheet | Documentation of Key Personnel
- Topic:
- Records Staff
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Factsheet
- Author:
- Sarah Rathjen (CRDO Education and Training Coordinator)
- Version #:
- 1.0
- Date of Publication:
- 10/01/2024
- Title:
- MCTC165 SOP | Informed Consent in Clinical Trials
- Topic:
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 14/03/2024
- Title:
- Melbourne Children's DERP User Guide for Researchers
- Topic:
- Other Governance Ethics
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance
- Department:
- Function:
- Guidance
- Author:
- Research Ethics and Governance (REG RCH)
- Version #:
- 1.0
- Date of Publication:
- 12/02/2024
- Title:
- MCTC202 Template | Archiving Box Label
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 12/04/2024
- Title:
- MCTC203 Template | GRACE Archiving Log
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 12/04/2024
- Title:
- MCTC199 SOP | Internal Auditing
- Topic:
- Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Jenny Munro & Di Tucker (Research Governance Manager & NCTGF Project Manager)
- Version #:
- 1.0
- Date of Publication:
- 01/08/2024
- Title:
- MCTC214 Work Instruction | Change of Investigator for Commercially Sponsored Trials (CSTs)
- Topic:
- Staff Ethics
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Melbourne Children's Trials Centre
- Function:
- Work Instructions
- Author:
- Jade Sheppard (MCTC )
- Version #:
- 1.0
- Date of Publication:
- 13/09/2024
- Title:
- MCTC216 Form | eCRF Data Review and Sign Off by PI
- Topic:
- Data Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Form
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 07/02/2025
- Title:
- MCTC071 Guidance | eInvestigator Site File Filing (eISF) for MCRI sponsored clinical trials
- Topic:
- Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Melbourne Children's Trials Centre
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.2
- Date of Publication:
- 01/12/2022
- Title:
- MCTC014 Guidance | Filing definitions and Principles
- Topic:
- Data Records Reporting Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.0
- Date of Publication:
- 02/03/2022
- Title:
- MCTC050 Guidance | Data and Safety Monitoring Boards (DSMB)
- Topic:
- Monitoring / QA Data Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 08/07/2021
- Title:
- MCTC051 Template | DSMB Charter
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 07/07/2021
- Title:
- MCTC038 Guidance | Setting up a research project budget
- Topic:
- Other Finance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 10/11/2016
- Title:
- MCTC036 Template | Budgets
- Topic:
- Other Finance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 18/05/2016
- Title:
- MCTC003 Guidance | Developing, amending and complying with research protocols
- Topic:
- Protocol
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 11/10/2017
- Title:
- MCTC029 Template | Study/Trial Steering Committee (SSC/TSC) Charter
- Topic:
- Governance Protocol Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 22/09/2020
- Title:
- MCTC052 Template | DSMB Meeting Agenda
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC053 Template | DSMB Open Report
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC011 Guidance | Investigator Site File - Table of Contents Document Filing
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC118 Template | ISF Paper binder section dividers
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC117 Template | ISF Table of Contents
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC106 Guidance | Principles of the General Data Protection Regulation (GDPR) & Data Protection in a Research Context
- Topic:
- Governance Reporting Data
- Applicability:
- Other Quality Assurance Intervention: no drug/device Intervention: drug/device Observational
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC107 Factsheet | GDPR Guidelines for Researchers: Information Sheet & Quick Facts
- Topic:
- Governance Reporting Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC009 Form | Sample Protocol Feasibility Checklist
- Topic:
- Protocol
- Applicability:
- Intervention: no drug/device Intervention: drug/device
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 25/01/2023
- Title:
- MCTC049 Template | Study task timeline
- Topic:
- Other Approvals
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 12/04/2017
- Title:
- MCTC016 Template | Notification of Site Activation
- Topic:
- Other Approvals Governance Protocol Reporting
- Applicability:
- Observational Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 04/01/2020
- Title:
- MCTC122 Template | Site Initiation Booking Confirmation Letter
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.1
- Date of Publication:
- 23/08/2021
- Title:
- MCTC132 Template | Site Initiation Meeting Agenda
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: no drug/device Intervention: drug/device Observational
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 03/02/2022
- Title:
- MCTC140 Template | Essential document request letter prior to site initiation
- Topic:
- Approvals Governance Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC141 Template | Site Initiation Follow up Letter
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC142 Template | Site Initiation Follow up Report
- Topic:
- Approvals Governance Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC054 SOP | Handling, Processing, Storage and Transport of Biospecimens in Human Research
- Topic:
- Safety Staff Equipment Other
- Applicability:
- Intervention: no drug/device Intervention: drug/device Other Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Saranga Senanayake (Research Coordinator, MCTC)
- Version #:
- 2.0
- Date of Publication:
- 19/05/2023
- Title:
- MCTC061 SOP | Continuous improvement: A Corrective and Preventative Action (CAPA) Plan
- Topic:
- Safety Reporting Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC080 Template | CAPA Plan
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC081 Template | CAPA Tracking Log
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC008 Template | Expedited Safety Report Form
- Topic:
- Safety Reporting
- Applicability:
- Intervention: no drug/device Intervention: drug/device
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 18/03/2020
- Title:
- MCTC018 Template | Clinical Review of Safety Events
- Topic:
- Safety Reporting Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 29/07/2022
- Title:
- MCTC112 SOP | MCRI/RCH Site Principal Investigator Management of Non-Compliance: Protocol Deviations and Serious Breaches
- Topic:
- Reporting Protocol Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Natalie Rose, Kate Scarff (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 24/03/2022
- Title:
- MCTC109 Form | Third Party Suspected Breach Report
- Topic:
- Protocol Reporting Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other Quality Assurance
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 01/07/2021
- Title:
- MCTC125 Form | Non-Compliance Review
- Topic:
- Reporting Protocol Safety Other Governance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 23/03/2022
- Title:
- MCTC127 Template | Site Non-Compliance Log
- Topic:
- Monitoring / QA Protocol Reporting Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 30/06/2021
- Title:
- MCTC126 Template | Central Non-Compliance Log
- Topic:
- Other Safety Reporting Protocol Governance
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 30/06/2021
- Title:
- MCTC128 Timeline | Non-Compliance Reporting
- Topic:
- Reporting Safety Protocol Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 23/03/2022
- Title:
- MCTC047 Template | Clinical Monitoring Plan for IITs
- Topic:
- Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 01/05/2018
- Title:
- MCTC072 Factsheet | Using Teams for Trial Monitoring
- Topic:
- Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC073 Factsheet | Access Parkville Connect for Trial Monitoring
- Topic:
- Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Factsheet
- Author:
- Iona Walton (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 21/10/2024
- Title:
- MCTC028 Template | Note to File
- Topic:
- Records Other Governance Monitoring / QA Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 4.0
- Date of Publication:
- 13/06/2023
- Title:
- MCTC044 Flowchart | Ethics & Governance Process for Lead and Accepting Sites
- Topic:
- Approvals Ethics Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 10/10/2017
- Title:
- MCTC099 Form | Wet Ink Signature Page
- Topic:
- Software Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- Iona Walton (CRDO)
- Version #:
- 2.1
- Date of Publication:
- 07/03/2024
- Title:
- MCTC101 SOP | Commercially Sponsored Florence eBinders Management
- Topic:
- Software Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 07/12/2020
- Title:
- MCTC103 Guidance | eISF Workflows and eSignature Reference Guide for Commercially Sponsored Studies
- Topic:
- Software Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- Iona Walton (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 10/01/2024
- Title:
- MCTC108 Template | Data Protection Checklist
- Topic:
- Approvals Consent Ethics Data Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Template
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC065 SOP | Study Start up for Clinical Trials
- Topic:
- Approvals Governance Other Records Ethics Monitoring / QA Protocol
- Applicability:
- Intervention: drug/device Observational Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 2.0
- Date of Publication:
- 05/04/2023
- Title:
- MCTC180 Form | Protocol Approval Form
- Topic:
- Protocol Approvals
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 21/03/2023
- Title:
- MCTC179 Form | PICF Approval Form
- Topic:
- Approvals Consent Recruitment
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Form
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 21/03/2023
- Title:
- MCTC181 Guidance | CST ISF Table of Contents
- Topic:
- Records Other Data Sponsorship
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Guidance
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 09/03/2023
- Title:
- CEBU | REDCap Project User Management for Trials
- Topic:
- Data Software
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Clinical Epidemiology & Biostatistics (CEBU)
- Function:
- Standard Operating Procedure
- Author:
- Luke Stevens (Research Data Systems Manager, CEBU)
- Version #:
- 1.0
- Date of Publication:
- 06/05/2022
- Title:
- CEBU | REDCap Project Change Controls for Trials
- Topic:
- Data Software
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Clinical Epidemiology & Biostatistics (CEBU)
- Function:
- Standard Operating Procedure
- Author:
- Luke Stevens (Research Data Systems Manager, CEBU)
- Version #:
- 1.0
- Date of Publication:
- 06/05/2022
- Title:
- MCTC054.01 Template | Sample Tracking and Processing Log
- Topic:
- Records Safety Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Bio-Banking Facility
- Function:
- Template
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 19/05/2023
- Title:
- MCTC 019 Template | CST Recruitment Plan
- Topic:
- Recruitment
- Applicability:
- Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Template
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 01/06/2023
- Title:
- MCTC032 SOP | Archiving in Florence eBinders
- Topic:
- Data Records Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 06/07/2023
- Title:
- MCTC200 Factsheet | Documentation of Key Personnel
- Topic:
- Records Staff
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Factsheet
- Author:
- Sarah Rathjen (CRDO Education and Training Coordinator)
- Version #:
- 1.0
- Date of Publication:
- 10/01/2024
- Title:
- MCTC165 SOP | Informed Consent in Clinical Trials
- Topic:
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 14/03/2024
- Title:
- Melbourne Children's DERP User Guide for Researchers
- Topic:
- Other Governance Ethics
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance
- Department:
- Function:
- Guidance
- Author:
- Research Ethics and Governance (REG RCH)
- Version #:
- 1.0
- Date of Publication:
- 12/02/2024
- Title:
- MCTC202 Template | Archiving Box Label
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 12/04/2024
- Title:
- MCTC203 Template | GRACE Archiving Log
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 12/04/2024
- Title:
- MCTC199 SOP | Internal Auditing
- Topic:
- Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Jenny Munro & Di Tucker (Research Governance Manager & NCTGF Project Manager)
- Version #:
- 1.0
- Date of Publication:
- 01/08/2024
- Title:
- MCTC194a SOP | Trial-Specific Qualification, Education, and Training – Clinical Trials Team Members
- Topic:
- Records Staff Other
- Applicability:
- Intervention: no drug/device N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Sarah Rathjen (Project Officer – Education and Training Coordinator)
- Version #:
- 1.1
- Date of Publication:
- 22/11/2024
- Title:
- MCTC214 Work Instruction | Change of Investigator for Commercially Sponsored Trials (CSTs)
- Topic:
- Staff Ethics
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Melbourne Children's Trials Centre
- Function:
- Work Instructions
- Author:
- Jade Sheppard (MCTC )
- Version #:
- 1.0
- Date of Publication:
- 13/09/2024
- Title:
- MCTC216 Form | eCRF Data Review and Sign Off by PI
- Topic:
- Data Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Form
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 07/02/2025
- Title:
- MCTC071 Guidance | eInvestigator Site File Filing (eISF) for MCRI sponsored clinical trials
- Topic:
- Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Melbourne Children's Trials Centre
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.2
- Date of Publication:
- 01/12/2022
- Title:
- MCTC014 Guidance | Filing definitions and Principles
- Topic:
- Data Records Reporting Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.0
- Date of Publication:
- 02/03/2022
- Title:
- MCTC050 Guidance | Data and Safety Monitoring Boards (DSMB)
- Topic:
- Monitoring / QA Data Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 08/07/2021
- Title:
- MCTC003 Guidance | Developing, amending and complying with research protocols
- Topic:
- Protocol
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 11/10/2017
- Title:
- MCTC029 Template | Study/Trial Steering Committee (SSC/TSC) Charter
- Topic:
- Governance Protocol Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 22/09/2020
- Title:
- MCTC052 Template | DSMB Meeting Agenda
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC053 Template | DSMB Open Report
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC106 Guidance | Principles of the General Data Protection Regulation (GDPR) & Data Protection in a Research Context
- Topic:
- Governance Reporting Data
- Applicability:
- Other Quality Assurance Intervention: no drug/device Intervention: drug/device Observational
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC107 Factsheet | GDPR Guidelines for Researchers: Information Sheet & Quick Facts
- Topic:
- Governance Reporting Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC049 Template | Study task timeline
- Topic:
- Other Approvals
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 12/04/2017
- Title:
- MCTC016 Template | Notification of Site Activation
- Topic:
- Other Approvals Governance Protocol Reporting
- Applicability:
- Observational Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 04/01/2020
- Title:
- MCTC122 Template | Site Initiation Booking Confirmation Letter
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.1
- Date of Publication:
- 23/08/2021
- Title:
- MCTC132 Template | Site Initiation Meeting Agenda
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: no drug/device Intervention: drug/device Observational
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 03/02/2022
- Title:
- MCTC141 Template | Site Initiation Follow up Letter
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC142 Template | Site Initiation Follow up Report
- Topic:
- Approvals Governance Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC054 SOP | Handling, Processing, Storage and Transport of Biospecimens in Human Research
- Topic:
- Safety Staff Equipment Other
- Applicability:
- Intervention: no drug/device Intervention: drug/device Other Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Saranga Senanayake (Research Coordinator, MCTC)
- Version #:
- 2.0
- Date of Publication:
- 19/05/2023
- Title:
- MCTC061 SOP | Continuous improvement: A Corrective and Preventative Action (CAPA) Plan
- Topic:
- Safety Reporting Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC112 SOP | MCRI/RCH Site Principal Investigator Management of Non-Compliance: Protocol Deviations and Serious Breaches
- Topic:
- Reporting Protocol Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Natalie Rose, Kate Scarff (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 24/03/2022
- Title:
- MCTC109 Form | Third Party Suspected Breach Report
- Topic:
- Protocol Reporting Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other Quality Assurance
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 01/07/2021
- Title:
- MCTC125 Form | Non-Compliance Review
- Topic:
- Reporting Protocol Safety Other Governance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 23/03/2022
- Title:
- MCTC044 Flowchart | Ethics & Governance Process for Lead and Accepting Sites
- Topic:
- Approvals Ethics Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 10/10/2017
- Title:
- MCTC099 Form | Wet Ink Signature Page
- Topic:
- Software Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- Iona Walton (CRDO)
- Version #:
- 2.1
- Date of Publication:
- 07/03/2024
- Title:
- MCTC101 SOP | Commercially Sponsored Florence eBinders Management
- Topic:
- Software Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 07/12/2020
- Title:
- MCTC103 Guidance | eISF Workflows and eSignature Reference Guide for Commercially Sponsored Studies
- Topic:
- Software Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- Iona Walton (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 10/01/2024
- Title:
- MCTC108 Template | Data Protection Checklist
- Topic:
- Approvals Consent Ethics Data Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Template
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC065 SOP | Study Start up for Clinical Trials
- Topic:
- Approvals Governance Other Records Ethics Monitoring / QA Protocol
- Applicability:
- Intervention: drug/device Observational Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 2.0
- Date of Publication:
- 05/04/2023
- Title:
- CEBU | REDCap Project User Management for Trials
- Topic:
- Data Software
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Clinical Epidemiology & Biostatistics (CEBU)
- Function:
- Standard Operating Procedure
- Author:
- Luke Stevens (Research Data Systems Manager, CEBU)
- Version #:
- 1.0
- Date of Publication:
- 06/05/2022
- Title:
- CEBU | REDCap Project Change Controls for Trials
- Topic:
- Data Software
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Clinical Epidemiology & Biostatistics (CEBU)
- Function:
- Standard Operating Procedure
- Author:
- Luke Stevens (Research Data Systems Manager, CEBU)
- Version #:
- 1.0
- Date of Publication:
- 06/05/2022
- Title:
- MCTC054.01 Template | Sample Tracking and Processing Log
- Topic:
- Records Safety Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Bio-Banking Facility
- Function:
- Template
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 19/05/2023
- Title:
- MCTC032 SOP | Archiving in Florence eBinders
- Topic:
- Data Records Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 06/07/2023
- Title:
- MCTC200 Factsheet | Documentation of Key Personnel
- Topic:
- Records Staff
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Factsheet
- Author:
- Sarah Rathjen (CRDO Education and Training Coordinator)
- Version #:
- 1.0
- Date of Publication:
- 10/01/2024
- Title:
- Melbourne Children's DERP User Guide for Researchers
- Topic:
- Other Governance Ethics
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance
- Department:
- Function:
- Guidance
- Author:
- Research Ethics and Governance (REG RCH)
- Version #:
- 1.0
- Date of Publication:
- 12/02/2024
- Title:
- MCTC199 SOP | Internal Auditing
- Topic:
- Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Jenny Munro & Di Tucker (Research Governance Manager & NCTGF Project Manager)
- Version #:
- 1.0
- Date of Publication:
- 01/08/2024
- Title:
- Qualitative Research Community of Practice Terms of Reference
- Topic:
- Other
- Applicability:
- Qualitative
- Department:
- Function:
- Policy
- Author:
- Kate Paton (QRCoP Lead)
- Version #:
- 2.0
- Date of Publication:
- 26/07/2023
- Title:
- MCTC191 Factsheet | Qualitative Research Virtual Focus Groups and Interviews
- Topic:
- Other
- Applicability:
- Qualitative
- Department:
- Function:
- Factsheet
- Author:
- Kate Paton (QRCoP)
- Version #:
- 1.0
- Date of Publication:
- 17/10/2023
- Title:
- MCTC071 Guidance | eInvestigator Site File Filing (eISF) for MCRI sponsored clinical trials
- Topic:
- Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Melbourne Children's Trials Centre
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.2
- Date of Publication:
- 01/12/2022
- Title:
- MCTC014 Guidance | Filing definitions and Principles
- Topic:
- Data Records Reporting Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.0
- Date of Publication:
- 02/03/2022
- Title:
- MCTC050 Guidance | Data and Safety Monitoring Boards (DSMB)
- Topic:
- Monitoring / QA Data Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 08/07/2021
- Title:
- MCTC106 Guidance | Principles of the General Data Protection Regulation (GDPR) & Data Protection in a Research Context
- Topic:
- Governance Reporting Data
- Applicability:
- Other Quality Assurance Intervention: no drug/device Intervention: drug/device Observational
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC107 Factsheet | GDPR Guidelines for Researchers: Information Sheet & Quick Facts
- Topic:
- Governance Reporting Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC109 Form | Third Party Suspected Breach Report
- Topic:
- Protocol Reporting Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other Quality Assurance
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 01/07/2021
- Title:
- MCTC054.01 Template | Sample Tracking and Processing Log
- Topic:
- Records Safety Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Bio-Banking Facility
- Function:
- Template
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 19/05/2023
- Title:
- Melbourne Children's DERP User Guide for Researchers
- Topic:
- Other Governance Ethics
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance
- Department:
- Function:
- Guidance
- Author:
- Research Ethics and Governance (REG RCH)
- Version #:
- 1.0
- Date of Publication:
- 12/02/2024
- Title:
- MCTC071 Guidance | eInvestigator Site File Filing (eISF) for MCRI sponsored clinical trials
- Topic:
- Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Melbourne Children's Trials Centre
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.2
- Date of Publication:
- 01/12/2022
- Title:
- MCTC014 Guidance | Filing definitions and Principles
- Topic:
- Data Records Reporting Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.0
- Date of Publication:
- 02/03/2022
- Title:
- MCTC050 Guidance | Data and Safety Monitoring Boards (DSMB)
- Topic:
- Monitoring / QA Data Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 08/07/2021
- Title:
- MCTC051 Template | DSMB Charter
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 07/07/2021
- Title:
- MCTC038 Guidance | Setting up a research project budget
- Topic:
- Other Finance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 10/11/2016
- Title:
- MCTC036 Template | Budgets
- Topic:
- Other Finance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 18/05/2016
- Title:
- MCTC003 Guidance | Developing, amending and complying with research protocols
- Topic:
- Protocol
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 11/10/2017
- Title:
- MCTC029 Template | Study/Trial Steering Committee (SSC/TSC) Charter
- Topic:
- Governance Protocol Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 22/09/2020
- Title:
- MCTC052 Template | DSMB Meeting Agenda
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC053 Template | DSMB Open Report
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC045 Workflow | Clinical Trial Contracts, Indemnities and Clinical Trial Notification Process Map
- Topic:
- Governance Approvals Reporting Other
- Applicability:
- Intervention: drug/device Other
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 19/12/2017
- Title:
- MCTC011 Guidance | Investigator Site File - Table of Contents Document Filing
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC118 Template | ISF Paper binder section dividers
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC117 Template | ISF Table of Contents
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC106 Guidance | Principles of the General Data Protection Regulation (GDPR) & Data Protection in a Research Context
- Topic:
- Governance Reporting Data
- Applicability:
- Other Quality Assurance Intervention: no drug/device Intervention: drug/device Observational
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC107 Factsheet | GDPR Guidelines for Researchers: Information Sheet & Quick Facts
- Topic:
- Governance Reporting Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC016 Template | Notification of Site Activation
- Topic:
- Other Approvals Governance Protocol Reporting
- Applicability:
- Observational Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 04/01/2020
- Title:
- MCTC140 Template | Essential document request letter prior to site initiation
- Topic:
- Approvals Governance Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC141 Template | Site Initiation Follow up Letter
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC142 Template | Site Initiation Follow up Report
- Topic:
- Approvals Governance Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/03/2022
- Title:
- MCTC054 SOP | Handling, Processing, Storage and Transport of Biospecimens in Human Research
- Topic:
- Safety Staff Equipment Other
- Applicability:
- Intervention: no drug/device Intervention: drug/device Other Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Saranga Senanayake (Research Coordinator, MCTC)
- Version #:
- 2.0
- Date of Publication:
- 19/05/2023
- Title:
- MCTC061 SOP | Continuous improvement: A Corrective and Preventative Action (CAPA) Plan
- Topic:
- Safety Reporting Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC080 Template | CAPA Plan
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC081 Template | CAPA Tracking Log
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC112 SOP | MCRI/RCH Site Principal Investigator Management of Non-Compliance: Protocol Deviations and Serious Breaches
- Topic:
- Reporting Protocol Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Natalie Rose, Kate Scarff (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 24/03/2022
- Title:
- MCTC109 Form | Third Party Suspected Breach Report
- Topic:
- Protocol Reporting Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other Quality Assurance
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 01/07/2021
- Title:
- MCTC125 Form | Non-Compliance Review
- Topic:
- Reporting Protocol Safety Other Governance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 23/03/2022
- Title:
- MCTC044 Flowchart | Ethics & Governance Process for Lead and Accepting Sites
- Topic:
- Approvals Ethics Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 10/10/2017
- Title:
- MCTC099 Form | Wet Ink Signature Page
- Topic:
- Software Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- Iona Walton (CRDO)
- Version #:
- 2.1
- Date of Publication:
- 07/03/2024
- Title:
- MCTC101 SOP | Commercially Sponsored Florence eBinders Management
- Topic:
- Software Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 07/12/2020
- Title:
- MCTC103 Guidance | eISF Workflows and eSignature Reference Guide for Commercially Sponsored Studies
- Topic:
- Software Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- Iona Walton (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 10/01/2024
- Title:
- MCTC065 SOP | Study Start up for Clinical Trials
- Topic:
- Approvals Governance Other Records Ethics Monitoring / QA Protocol
- Applicability:
- Intervention: drug/device Observational Intervention: no drug/device Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Laura Galletta (MCTC)
- Version #:
- 2.0
- Date of Publication:
- 05/04/2023
- Title:
- MCTC172 Factsheet | CAAA IATA Shippers Training Course Booking Process
- Topic:
- Safety Staff Other Equipment
- Applicability:
- Intervention: drug/device Other
- Department:
- Function:
- Factsheet
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 06/02/2023
- Title:
- CEBU | REDCap Project Change Controls for Trials
- Topic:
- Data Software
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Clinical Epidemiology & Biostatistics (CEBU)
- Function:
- Standard Operating Procedure
- Author:
- Luke Stevens (Research Data Systems Manager, CEBU)
- Version #:
- 1.0
- Date of Publication:
- 06/05/2022
- Title:
- MCTC054.01 Template | Sample Tracking and Processing Log
- Topic:
- Records Safety Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Bio-Banking Facility
- Function:
- Template
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 19/05/2023
- Title:
- MCTC 019 Template | CST Recruitment Plan
- Topic:
- Recruitment
- Applicability:
- Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Template
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 01/06/2023
- Title:
- MCTC032 SOP | Archiving in Florence eBinders
- Topic:
- Data Records Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 06/07/2023
- Title:
- MCTC200 Factsheet | Documentation of Key Personnel
- Topic:
- Records Staff
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Factsheet
- Author:
- Sarah Rathjen (CRDO Education and Training Coordinator)
- Version #:
- 1.0
- Date of Publication:
- 10/01/2024
- Title:
- MCTC014 Guidance | Filing definitions and Principles
- Topic:
- Data Records Reporting Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.0
- Date of Publication:
- 02/03/2022
- Title:
- MCTC136 Template | Site Initiation Attendance Log
- Topic:
- Approvals Governance Other
- Applicability:
- N/A
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 03/02/2022
- Title:
- MCTC039 Template | Study Level Close Out Visit Report and Checklist
- Topic:
- Reporting Records Other
- Applicability:
- N/A
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 3.0
- Date of Publication:
- 04/10/2024
- Title:
- MCTC061 SOP | Continuous improvement: A Corrective and Preventative Action (CAPA) Plan
- Topic:
- Safety Reporting Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC080 Template | CAPA Plan
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC081 Template | CAPA Tracking Log
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC194a SOP | Trial-Specific Qualification, Education, and Training – Clinical Trials Team Members
- Topic:
- Records Staff Other
- Applicability:
- Intervention: no drug/device N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Sarah Rathjen (Project Officer – Education and Training Coordinator)
- Version #:
- 1.1
- Date of Publication:
- 22/11/2024
- Title:
- MCTC207 Template | Site Level Close Out Visit Report and Checklist
- Topic:
- Records Other
- Applicability:
- N/A
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 04/10/2024
- Title:
- MCTC071 Guidance | eInvestigator Site File Filing (eISF) for MCRI sponsored clinical trials
- Topic:
- Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Melbourne Children's Trials Centre
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.2
- Date of Publication:
- 01/12/2022
- Title:
- MCTC001 Guidance | Creation of New Standard Operating Procedures
- Topic:
- Other Governance Protocol
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Melbourne Children's Trials Centre Data Management
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 2.0
- Date of Publication:
- 26/09/2022
- Title:
- MCTC014 Guidance | Filing definitions and Principles
- Topic:
- Data Records Reporting Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.0
- Date of Publication:
- 02/03/2022
- Title:
- MCTC050 Guidance | Data and Safety Monitoring Boards (DSMB)
- Topic:
- Monitoring / QA Data Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 08/07/2021
- Title:
- MCTC051 Template | DSMB Charter
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 07/07/2021
- Title:
- MCTC038 Guidance | Setting up a research project budget
- Topic:
- Other Finance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 10/11/2016
- Title:
- MCTC036 Template | Budgets
- Topic:
- Other Finance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 18/05/2016
- Title:
- MCTC003 Guidance | Developing, amending and complying with research protocols
- Topic:
- Protocol
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 11/10/2017
- Title:
- MCTC063 Template | Melbourne Children's clinical trial (drug or device intervention) protocol
- Topic:
- Protocol
- Applicability:
- Intervention: drug/device
- Department:
- Function:
- Template
- Author:
- CRDO & CEBU (CRDO)
- Version #:
- 5.0
- Date of Publication:
- 19/12/2024
- Title:
- MCTC029 Template | Study/Trial Steering Committee (SSC/TSC) Charter
- Topic:
- Governance Protocol Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 22/09/2020
- Title:
- MCTC052 Template | DSMB Meeting Agenda
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC053 Template | DSMB Open Report
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC045 Workflow | Clinical Trial Contracts, Indemnities and Clinical Trial Notification Process Map
- Topic:
- Governance Approvals Reporting Other
- Applicability:
- Intervention: drug/device Other
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 19/12/2017
- Title:
- MCTC012 Guidance | Trial Master File (TMF) Table of Contents Document Filing
- Topic:
- Records Other
- Applicability:
- Other Intervention: no drug/device Intervention: drug/device
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 06/06/2021
- Title:
- MCTC119 Template | TMF Table of Contents
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/12/2020
- Title:
- MCTC120 Template | TMF Paper binder section dividers
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC013 Guidance | Site Investigator File (SIF) Essential Document Filing
- Topic:
- Records
- Applicability:
- Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 02/06/2021
- Title:
- MCTC115 Template | SIF Table of Contents
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC116 Template | SIF Paper binder section dividers
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC011 Guidance | Investigator Site File - Table of Contents Document Filing
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC118 Template | ISF Paper binder section dividers
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC117 Template | ISF Table of Contents
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC106 Guidance | Principles of the General Data Protection Regulation (GDPR) & Data Protection in a Research Context
- Topic:
- Governance Reporting Data
- Applicability:
- Other Quality Assurance Intervention: no drug/device Intervention: drug/device Observational
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC107 Factsheet | GDPR Guidelines for Researchers: Information Sheet & Quick Facts
- Topic:
- Governance Reporting Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC170 SOP | Archiving Clinical Trial Investigator Site Files
- Topic:
- Data Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Angela Karandaglidis (Clinical Trial Assistant)
- Version #:
- 1.0
- Date of Publication:
- 12/04/2024
- Title:
- MCTC009 Form | Sample Protocol Feasibility Checklist
- Topic:
- Protocol
- Applicability:
- Intervention: no drug/device Intervention: drug/device
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 25/01/2023
- Title:
- MCTC056 Form | Checklist for Trial development and Start-up
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 09/08/2021
- Title:
- MCTC016 Template | Notification of Site Activation
- Topic:
- Other Approvals Governance Protocol Reporting
- Applicability:
- Observational Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 04/01/2020
- Title:
- MCTC017 Template | Study Staff Training Logs
- Topic:
- Safety Staff Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 30/03/2020
- Title:
- MCTC025 Guidance | Signature and Delegation Logs
- Topic:
- Reporting Records Safety Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 3.1
- Date of Publication:
- 30/06/2023
- Title:
- MCTC040 Template | Investigator Short CV
- Topic:
- Staff Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 21/03/2017
- Title:
- MCTC062 Guidance | Recruitment, screening and enrolment of research particpants
- Topic:
- Recruitment
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC057 Template | Pre-Screening Log
- Topic:
- Recruitment
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 23/01/2019
- Title:
- MCTC058 Template | Participant Consent, Screening & Enrolment Log
- Topic:
- Recruitment Other Consent
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 23/01/2019
- Title:
- MCTC015 Template | Source document plan
- Topic:
- Monitoring / QA Data Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 26/03/2020
- Title:
- MCTC004 Guidance | Data collection for research: Source documents and the Case Report Form
- Topic:
- Data Reporting Records
- Applicability:
- Quality Assurance Observational Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 31/08/2015
- Title:
- MCTC035 Template | Risk Assessment and Risk Management Tool for Clinical Trials
- Topic:
- Sponsorship Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- MCTC (MCTC)
- Version #:
- 2.0
- Date of Publication:
- 05/10/2020
- Title:
- MCTC061 SOP | Continuous improvement: A Corrective and Preventative Action (CAPA) Plan
- Topic:
- Safety Reporting Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC080 Template | CAPA Plan
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC081 Template | CAPA Tracking Log
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC008 Template | Expedited Safety Report Form
- Topic:
- Safety Reporting
- Applicability:
- Intervention: no drug/device Intervention: drug/device
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 18/03/2020
- Title:
- MCTC018 Template | Clinical Review of Safety Events
- Topic:
- Safety Reporting Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 29/07/2022
- Title:
- MCTC172 Factsheet | CAAA IATA Shippers Training Course Booking Process
- Topic:
- Safety Staff Other Equipment
- Applicability:
- Intervention: drug/device Other
- Department:
- Function:
- Factsheet
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 06/02/2023
- Title:
- MCTC164 SOP | Management of Temperature Controlled Storage
- Topic:
- Equipment Other
- Applicability:
- Intervention: drug/device
- Department:
- Melbourne Children's Trials Centre Clinical Research
- Function:
- Standard Operating Procedure
- Author:
- Carolyn Stewart (MCTC Business and Operations Manager)
- Version #:
- 1.0
- Date of Publication:
- 18/04/2023
- Title:
- MCTC054.01 Template | Sample Tracking and Processing Log
- Topic:
- Records Safety Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Bio-Banking Facility
- Function:
- Template
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 19/05/2023
- Title:
- MCTC166 SOP | Management of Investigational Product
- Topic:
- Equipment Other Safety
- Applicability:
- Intervention: drug/device
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Saranga Senanayake (Research Coordinator, MCTC)
- Version #:
- 1.0
- Date of Publication:
- 20/06/2023
- Title:
- MCTC032 SOP | Archiving in Florence eBinders
- Topic:
- Data Records Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 06/07/2023
- Title:
- MCTC200 Factsheet | Documentation of Key Personnel
- Topic:
- Records Staff
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Factsheet
- Author:
- Sarah Rathjen (CRDO Education and Training Coordinator)
- Version #:
- 1.0
- Date of Publication:
- 10/01/2024
- Title:
- Melbourne Children's DERP User Guide for Researchers
- Topic:
- Other Governance Ethics
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance
- Department:
- Function:
- Guidance
- Author:
- Research Ethics and Governance (REG RCH)
- Version #:
- 1.0
- Date of Publication:
- 12/02/2024
- Title:
- MCTCRCH01 SOP | RCH Pharmacy Destruction of Clinical Trial Materials
- Topic:
- Applicability:
- Intervention: drug/device
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Joanne Cheah & Kee Lin Lim (Royal Children's Clinical Trials Pharamacy)
- Version #:
- 1.0
- Date of Publication:
- 01/08/2022
- Title:
- MCTCRCH02 SOP | RCH Pharmacy Dispensing Clinical Trial Materials
- Topic:
- Applicability:
- Intervention: drug/device
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Joanne Cheah & Kee Lin Lim (Royal Children's Clinical Trial Pharmacy)
- Version #:
- 1.0
- Date of Publication:
- 01/08/2022
- Title:
- MCTCRCH03 SOP | RCH Pharmacy Receipt of Clinical Trial Shipments – NON GMO needing Ultra cold storage
- Topic:
- Applicability:
- Intervention: drug/device
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Kee Lin Lim (Royal Children's Clinical Trials Pharmacy)
- Version #:
- 1.0
- Date of Publication:
- 01/01/2024
- Title:
- MCTCRCH04 SOP | RCH Pharmacy Receipt of Clinical Trial Shipments – NON GMO – NON Ultra cold storage
- Topic:
- Applicability:
- Intervention: drug/device
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Joanne Cheah & Kee Lin Lim (Royal Children's Clinical Trials Pharmacy)
- Version #:
- 1.0
- Date of Publication:
- 01/08/2022
- Title:
- MCTCRCH05 SOP | RCH Pharmacy Storage of Clinical Trial Drugs
- Topic:
- Applicability:
- Intervention: drug/device
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Jason Bell (Royal Children's Clinical Trials Pharmacy)
- Version #:
- 1.0
- Date of Publication:
- 01/09/2024
- Title:
- MCTC006 SOP | Management of Essential Documents
- Topic:
- Data Records Other Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/12/2024
- Title:
- MCTC066 Form | SIF QA Binder Review Checklist
- Topic:
- Monitoring / QA Records Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 16/08/2024
- Title:
- MCTC064 Form | TMF QA Review Planning Form
- Topic:
- Data Monitoring / QA Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 16/08/2024
- Title:
- MCTC071 Guidance | eInvestigator Site File Filing (eISF) for MCRI sponsored clinical trials
- Topic:
- Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Melbourne Children's Trials Centre
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.2
- Date of Publication:
- 01/12/2022
- Title:
- MCTC001 Guidance | Creation of New Standard Operating Procedures
- Topic:
- Other Governance Protocol
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Melbourne Children's Trials Centre Data Management
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 2.0
- Date of Publication:
- 26/09/2022
- Title:
- MCTC014 Guidance | Filing definitions and Principles
- Topic:
- Data Records Reporting Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.0
- Date of Publication:
- 02/03/2022
- Title:
- MCTC050 Guidance | Data and Safety Monitoring Boards (DSMB)
- Topic:
- Monitoring / QA Data Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 08/07/2021
- Title:
- MCTC051 Template | DSMB Charter
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 07/07/2021
- Title:
- MCTC038 Guidance | Setting up a research project budget
- Topic:
- Other Finance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 10/11/2016
- Title:
- MCTC036 Template | Budgets
- Topic:
- Other Finance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 18/05/2016
- Title:
- MCTC003 Guidance | Developing, amending and complying with research protocols
- Topic:
- Protocol
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 11/10/2017
- Title:
- MCTC059 Template | Melbourne Children's clinical trial (non-drug, non-biological, non-device intervention) protocol
- Topic:
- Protocol
- Applicability:
- Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO, CEBU (CRDO)
- Version #:
- 5.0
- Date of Publication:
- 02/09/2019
- Title:
- MCTC029 Template | Study/Trial Steering Committee (SSC/TSC) Charter
- Topic:
- Governance Protocol Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 22/09/2020
- Title:
- MCTC052 Template | DSMB Meeting Agenda
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC053 Template | DSMB Open Report
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC012 Guidance | Trial Master File (TMF) Table of Contents Document Filing
- Topic:
- Records Other
- Applicability:
- Other Intervention: no drug/device Intervention: drug/device
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 06/06/2021
- Title:
- MCTC119 Template | TMF Table of Contents
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/12/2020
- Title:
- MCTC120 Template | TMF Paper binder section dividers
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC013 Guidance | Site Investigator File (SIF) Essential Document Filing
- Topic:
- Records
- Applicability:
- Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 02/06/2021
- Title:
- MCTC115 Template | SIF Table of Contents
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC116 Template | SIF Paper binder section dividers
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC011 Guidance | Investigator Site File - Table of Contents Document Filing
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC118 Template | ISF Paper binder section dividers
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC117 Template | ISF Table of Contents
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC106 Guidance | Principles of the General Data Protection Regulation (GDPR) & Data Protection in a Research Context
- Topic:
- Governance Reporting Data
- Applicability:
- Other Quality Assurance Intervention: no drug/device Intervention: drug/device Observational
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC107 Factsheet | GDPR Guidelines for Researchers: Information Sheet & Quick Facts
- Topic:
- Governance Reporting Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC170 SOP | Archiving Clinical Trial Investigator Site Files
- Topic:
- Data Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Angela Karandaglidis (Clinical Trial Assistant)
- Version #:
- 1.0
- Date of Publication:
- 12/04/2024
- Title:
- MCTC009 Form | Sample Protocol Feasibility Checklist
- Topic:
- Protocol
- Applicability:
- Intervention: no drug/device Intervention: drug/device
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 25/01/2023
- Title:
- MCTC056 Form | Checklist for Trial development and Start-up
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 09/08/2021
- Title:
- MCTC016 Template | Notification of Site Activation
- Topic:
- Other Approvals Governance Protocol Reporting
- Applicability:
- Observational Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 04/01/2020
- Title:
- MCTC017 Template | Study Staff Training Logs
- Topic:
- Safety Staff Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 30/03/2020
- Title:
- MCTC025 Guidance | Signature and Delegation Logs
- Topic:
- Reporting Records Safety Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 3.1
- Date of Publication:
- 30/06/2023
- Title:
- MCTC040 Template | Investigator Short CV
- Topic:
- Staff Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 21/03/2017
- Title:
- MCTC062 Guidance | Recruitment, screening and enrolment of research particpants
- Topic:
- Recruitment
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC057 Template | Pre-Screening Log
- Topic:
- Recruitment
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 23/01/2019
- Title:
- MCTC058 Template | Participant Consent, Screening & Enrolment Log
- Topic:
- Recruitment Other Consent
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 23/01/2019
- Title:
- MCTC015 Template | Source document plan
- Topic:
- Monitoring / QA Data Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 26/03/2020
- Title:
- MCTC004 Guidance | Data collection for research: Source documents and the Case Report Form
- Topic:
- Data Reporting Records
- Applicability:
- Quality Assurance Observational Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 31/08/2015
- Title:
- MCTC035 Template | Risk Assessment and Risk Management Tool for Clinical Trials
- Topic:
- Sponsorship Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- MCTC (MCTC)
- Version #:
- 2.0
- Date of Publication:
- 05/10/2020
- Title:
- MCTC061 SOP | Continuous improvement: A Corrective and Preventative Action (CAPA) Plan
- Topic:
- Safety Reporting Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC080 Template | CAPA Plan
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC081 Template | CAPA Tracking Log
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC008 Template | Expedited Safety Report Form
- Topic:
- Safety Reporting
- Applicability:
- Intervention: no drug/device Intervention: drug/device
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 18/03/2020
- Title:
- MCTC018 Template | Clinical Review of Safety Events
- Topic:
- Safety Reporting Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 29/07/2022
- Title:
- MCTC054.01 Template | Sample Tracking and Processing Log
- Topic:
- Records Safety Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Bio-Banking Facility
- Function:
- Template
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 19/05/2023
- Title:
- MCTC032 SOP | Archiving in Florence eBinders
- Topic:
- Data Records Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 06/07/2023
- Title:
- MCTC200 Factsheet | Documentation of Key Personnel
- Topic:
- Records Staff
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Factsheet
- Author:
- Sarah Rathjen (CRDO Education and Training Coordinator)
- Version #:
- 1.0
- Date of Publication:
- 10/01/2024
- Title:
- Melbourne Children's DERP User Guide for Researchers
- Topic:
- Other Governance Ethics
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance
- Department:
- Function:
- Guidance
- Author:
- Research Ethics and Governance (REG RCH)
- Version #:
- 1.0
- Date of Publication:
- 12/02/2024
- Title:
- MCTC194a SOP | Trial-Specific Qualification, Education, and Training – Clinical Trials Team Members
- Topic:
- Records Staff Other
- Applicability:
- Intervention: no drug/device N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Sarah Rathjen (Project Officer – Education and Training Coordinator)
- Version #:
- 1.1
- Date of Publication:
- 22/11/2024
- Title:
- MCTC006 SOP | Management of Essential Documents
- Topic:
- Data Records Other Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/12/2024
- Title:
- MCTC066 Form | SIF QA Binder Review Checklist
- Topic:
- Monitoring / QA Records Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 16/08/2024
- Title:
- MCTC064 Form | TMF QA Review Planning Form
- Topic:
- Data Monitoring / QA Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 16/08/2024
- Title:
- MCTC071 Guidance | eInvestigator Site File Filing (eISF) for MCRI sponsored clinical trials
- Topic:
- Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Melbourne Children's Trials Centre
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.2
- Date of Publication:
- 01/12/2022
- Title:
- MCTC001 Guidance | Creation of New Standard Operating Procedures
- Topic:
- Other Governance Protocol
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Melbourne Children's Trials Centre Data Management
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 2.0
- Date of Publication:
- 26/09/2022
- Title:
- MCTC014 Guidance | Filing definitions and Principles
- Topic:
- Data Records Reporting Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.0
- Date of Publication:
- 02/03/2022
- Title:
- MCTC050 Guidance | Data and Safety Monitoring Boards (DSMB)
- Topic:
- Monitoring / QA Data Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 08/07/2021
- Title:
- MCTC003 Guidance | Developing, amending and complying with research protocols
- Topic:
- Protocol
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 11/10/2017
- Title:
- MCTC060 Template | Melbourne Children's observational studies protocol
- Topic:
- Protocol
- Applicability:
- Observational
- Department:
- Function:
- Template
- Author:
- CRDO, CEBU (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 04/06/2019
- Title:
- MCTC029 Template | Study/Trial Steering Committee (SSC/TSC) Charter
- Topic:
- Governance Protocol Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 22/09/2020
- Title:
- MCTC052 Template | DSMB Meeting Agenda
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC053 Template | DSMB Open Report
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC106 Guidance | Principles of the General Data Protection Regulation (GDPR) & Data Protection in a Research Context
- Topic:
- Governance Reporting Data
- Applicability:
- Other Quality Assurance Intervention: no drug/device Intervention: drug/device Observational
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC107 Factsheet | GDPR Guidelines for Researchers: Information Sheet & Quick Facts
- Topic:
- Governance Reporting Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC170 SOP | Archiving Clinical Trial Investigator Site Files
- Topic:
- Data Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Angela Karandaglidis (Clinical Trial Assistant)
- Version #:
- 1.0
- Date of Publication:
- 12/04/2024
- Title:
- MCTC056 Form | Checklist for Trial development and Start-up
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 09/08/2021
- Title:
- MCTC016 Template | Notification of Site Activation
- Topic:
- Other Approvals Governance Protocol Reporting
- Applicability:
- Observational Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 04/01/2020
- Title:
- MCTC062 Guidance | Recruitment, screening and enrolment of research particpants
- Topic:
- Recruitment
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC057 Template | Pre-Screening Log
- Topic:
- Recruitment
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 23/01/2019
- Title:
- MCTC058 Template | Participant Consent, Screening & Enrolment Log
- Topic:
- Recruitment Other Consent
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 23/01/2019
- Title:
- MCTC015 Template | Source document plan
- Topic:
- Monitoring / QA Data Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 26/03/2020
- Title:
- MCTC004 Guidance | Data collection for research: Source documents and the Case Report Form
- Topic:
- Data Reporting Records
- Applicability:
- Quality Assurance Observational Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 31/08/2015
- Title:
- MCTC061 SOP | Continuous improvement: A Corrective and Preventative Action (CAPA) Plan
- Topic:
- Safety Reporting Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC054.01 Template | Sample Tracking and Processing Log
- Topic:
- Records Safety Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Bio-Banking Facility
- Function:
- Template
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 19/05/2023
- Title:
- MCTC032 SOP | Archiving in Florence eBinders
- Topic:
- Data Records Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 06/07/2023
- Title:
- MCTC200 Factsheet | Documentation of Key Personnel
- Topic:
- Records Staff
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Factsheet
- Author:
- Sarah Rathjen (CRDO Education and Training Coordinator)
- Version #:
- 1.0
- Date of Publication:
- 10/01/2024
- Title:
- Melbourne Children's DERP User Guide for Researchers
- Topic:
- Other Governance Ethics
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance
- Department:
- Function:
- Guidance
- Author:
- Research Ethics and Governance (REG RCH)
- Version #:
- 1.0
- Date of Publication:
- 12/02/2024
- Title:
- MCTC006 SOP | Management of Essential Documents
- Topic:
- Data Records Other Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/12/2024
- Title:
- MCTC066 Form | SIF QA Binder Review Checklist
- Topic:
- Monitoring / QA Records Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 16/08/2024
- Title:
- MCTC064 Form | TMF QA Review Planning Form
- Topic:
- Data Monitoring / QA Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 16/08/2024
- Title:
- MCTC023 Factsheet | ChatGPT and Research
- Topic:
- Software Other
- Applicability:
- Qualitative
- Department:
- Office of Research
- Function:
- Factsheet
- Author:
- Kate Paton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 03/05/2023
- Title:
- MCTC020 Factsheet | Dictaphones
- Topic:
- Data Software Other
- Applicability:
- Qualitative
- Department:
- Function:
- Factsheet
- Author:
- Kate Paton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 23/06/2023
- Title:
- MCTC085 Factsheet | Use of external human transcription companies
- Topic:
- Software Other Records Data
- Applicability:
- Qualitative
- Department:
- Office of Research
- Function:
- Factsheet
- Author:
- Kate Paton (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 02/07/2024
- Title:
- MCTC086 Factsheet | Web conferencing transcription service guidelines
- Topic:
- Data Records Software Other
- Applicability:
- Qualitative
- Department:
- Office of Research
- Function:
- Factsheet
- Author:
- Kate Paton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 27/06/2023
- Title:
- Qualitative Research Guidelines
- Topic:
- Other
- Applicability:
- Qualitative
- Department:
- Function:
- Guidance
- Author:
- Kate Paton (QRIG)
- Version #:
- 3.0
- Date of Publication:
- 31/07/2023
- Title:
- Qualitative Research Community of Practice Terms of Reference
- Topic:
- Other
- Applicability:
- Qualitative
- Department:
- Function:
- Policy
- Author:
- Kate Paton (QRCoP Lead)
- Version #:
- 2.0
- Date of Publication:
- 26/07/2023
- Title:
- MCTC191 Factsheet | Qualitative Research Virtual Focus Groups and Interviews
- Topic:
- Other
- Applicability:
- Qualitative
- Department:
- Function:
- Factsheet
- Author:
- Kate Paton (QRCoP)
- Version #:
- 1.0
- Date of Publication:
- 17/10/2023
- Title:
- MCTC215 Factsheet | Use of MCRI NVivo enterprise licenses
- Topic:
- Applicability:
- Qualitative
- Department:
- Function:
- Factsheet
- Author:
- Kate Paton (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 30/10/2024
- Title:
- MCTC071 Guidance | eInvestigator Site File Filing (eISF) for MCRI sponsored clinical trials
- Topic:
- Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Melbourne Children's Trials Centre
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.2
- Date of Publication:
- 01/12/2022
- Title:
- MCTC001 Guidance | Creation of New Standard Operating Procedures
- Topic:
- Other Governance Protocol
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Melbourne Children's Trials Centre Data Management
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 2.0
- Date of Publication:
- 26/09/2022
- Title:
- MCTC014 Guidance | Filing definitions and Principles
- Topic:
- Data Records Reporting Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.0
- Date of Publication:
- 02/03/2022
- Title:
- MCTC050 Guidance | Data and Safety Monitoring Boards (DSMB)
- Topic:
- Monitoring / QA Data Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 08/07/2021
- Title:
- MCTC106 Guidance | Principles of the General Data Protection Regulation (GDPR) & Data Protection in a Research Context
- Topic:
- Governance Reporting Data
- Applicability:
- Other Quality Assurance Intervention: no drug/device Intervention: drug/device Observational
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC107 Factsheet | GDPR Guidelines for Researchers: Information Sheet & Quick Facts
- Topic:
- Governance Reporting Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC015 Template | Source document plan
- Topic:
- Monitoring / QA Data Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 26/03/2020
- Title:
- MCTC004 Guidance | Data collection for research: Source documents and the Case Report Form
- Topic:
- Data Reporting Records
- Applicability:
- Quality Assurance Observational Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 31/08/2015
- Title:
- MCTC054.01 Template | Sample Tracking and Processing Log
- Topic:
- Records Safety Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Bio-Banking Facility
- Function:
- Template
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 19/05/2023
- Title:
- Melbourne Children's DERP User Guide for Researchers
- Topic:
- Other Governance Ethics
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance
- Department:
- Function:
- Guidance
- Author:
- Research Ethics and Governance (REG RCH)
- Version #:
- 1.0
- Date of Publication:
- 12/02/2024
- Title:
- MCTC071 Guidance | eInvestigator Site File Filing (eISF) for MCRI sponsored clinical trials
- Topic:
- Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Melbourne Children's Trials Centre
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.2
- Date of Publication:
- 01/12/2022
- Title:
- MCTC001 Guidance | Creation of New Standard Operating Procedures
- Topic:
- Other Governance Protocol
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Melbourne Children's Trials Centre Data Management
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 2.0
- Date of Publication:
- 26/09/2022
- Title:
- MCTC014 Guidance | Filing definitions and Principles
- Topic:
- Data Records Reporting Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.0
- Date of Publication:
- 02/03/2022
- Title:
- MCTC050 Guidance | Data and Safety Monitoring Boards (DSMB)
- Topic:
- Monitoring / QA Data Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 08/07/2021
- Title:
- MCTC051 Template | DSMB Charter
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 07/07/2021
- Title:
- MCTC038 Guidance | Setting up a research project budget
- Topic:
- Other Finance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 10/11/2016
- Title:
- MCTC036 Template | Budgets
- Topic:
- Other Finance
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 18/05/2016
- Title:
- MCTC003 Guidance | Developing, amending and complying with research protocols
- Topic:
- Protocol
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Guidance
- Author:
- Fiona Williams (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 11/10/2017
- Title:
- MCTC029 Template | Study/Trial Steering Committee (SSC/TSC) Charter
- Topic:
- Governance Protocol Safety Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 22/09/2020
- Title:
- MCTC052 Template | DSMB Meeting Agenda
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC053 Template | DSMB Open Report
- Topic:
- Data Monitoring / QA Safety
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 30/11/2018
- Title:
- MCTC045 Workflow | Clinical Trial Contracts, Indemnities and Clinical Trial Notification Process Map
- Topic:
- Governance Approvals Reporting Other
- Applicability:
- Intervention: drug/device Other
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 19/12/2017
- Title:
- MCTC012 Guidance | Trial Master File (TMF) Table of Contents Document Filing
- Topic:
- Records Other
- Applicability:
- Other Intervention: no drug/device Intervention: drug/device
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 06/06/2021
- Title:
- MCTC119 Template | TMF Table of Contents
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/12/2020
- Title:
- MCTC120 Template | TMF Paper binder section dividers
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC013 Guidance | Site Investigator File (SIF) Essential Document Filing
- Topic:
- Records
- Applicability:
- Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 02/06/2021
- Title:
- MCTC115 Template | SIF Table of Contents
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC116 Template | SIF Paper binder section dividers
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC011 Guidance | Investigator Site File - Table of Contents Document Filing
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC118 Template | ISF Paper binder section dividers
- Topic:
- Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC117 Template | ISF Table of Contents
- Topic:
- Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 18/01/2021
- Title:
- MCTC106 Guidance | Principles of the General Data Protection Regulation (GDPR) & Data Protection in a Research Context
- Topic:
- Governance Reporting Data
- Applicability:
- Other Quality Assurance Intervention: no drug/device Intervention: drug/device Observational
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC107 Factsheet | GDPR Guidelines for Researchers: Information Sheet & Quick Facts
- Topic:
- Governance Reporting Data
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Function:
- Factsheet
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/04/2021
- Title:
- MCTC170 SOP | Archiving Clinical Trial Investigator Site Files
- Topic:
- Data Records Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Angela Karandaglidis (Clinical Trial Assistant)
- Version #:
- 1.0
- Date of Publication:
- 12/04/2024
- Title:
- MCTC056 Form | Checklist for Trial development and Start-up
- Topic:
- Approvals Governance Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 2.0
- Date of Publication:
- 09/08/2021
- Title:
- MCTC016 Template | Notification of Site Activation
- Topic:
- Other Approvals Governance Protocol Reporting
- Applicability:
- Observational Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 04/01/2020
- Title:
- MCTC017 Template | Study Staff Training Logs
- Topic:
- Safety Staff Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 30/03/2020
- Title:
- MCTC025 Guidance | Signature and Delegation Logs
- Topic:
- Reporting Records Safety Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 3.1
- Date of Publication:
- 30/06/2023
- Title:
- MCTC058 Template | Participant Consent, Screening & Enrolment Log
- Topic:
- Recruitment Other Consent
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 3.0
- Date of Publication:
- 23/01/2019
- Title:
- MCTC004 Guidance | Data collection for research: Source documents and the Case Report Form
- Topic:
- Data Reporting Records
- Applicability:
- Quality Assurance Observational Intervention: no drug/device Intervention: drug/device Other
- Department:
- Function:
- Guidance
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 31/08/2015
- Title:
- MCTC061 SOP | Continuous improvement: A Corrective and Preventative Action (CAPA) Plan
- Topic:
- Safety Reporting Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC080 Template | CAPA Plan
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC081 Template | CAPA Tracking Log
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC172 Factsheet | CAAA IATA Shippers Training Course Booking Process
- Topic:
- Safety Staff Other Equipment
- Applicability:
- Intervention: drug/device Other
- Department:
- Function:
- Factsheet
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 06/02/2023
- Title:
- MCTC160 Work Instruction | How to self-assign Ethics and Governance course MCRI
- Topic:
- Ethics Staff Other
- Applicability:
- Other N/A
- Department:
- Function:
- Work Instructions
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 28/04/2023
- Title:
- MCTC054.01 Template | Sample Tracking and Processing Log
- Topic:
- Records Safety Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other
- Department:
- Bio-Banking Facility
- Function:
- Template
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 19/05/2023
- Title:
- MCTC032 SOP | Archiving in Florence eBinders
- Topic:
- Data Records Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other Observational
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 06/07/2023
- Title:
- MCTC200 Factsheet | Documentation of Key Personnel
- Topic:
- Records Staff
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Factsheet
- Author:
- Sarah Rathjen (CRDO Education and Training Coordinator)
- Version #:
- 1.0
- Date of Publication:
- 10/01/2024
- Title:
- MCTC178 Factsheet | eSigantures and Digital Signatures
- Topic:
- Software Other
- Applicability:
- Other N/A
- Department:
- Function:
- Factsheet
- Author:
- Iona Walton (CRDO )
- Version #:
- 1.0
- Date of Publication:
- 07/06/2024
- Title:
- MCTC006 SOP | Management of Essential Documents
- Topic:
- Data Records Other Monitoring / QA
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 19/12/2024
- Title:
- MCTC064 Form | TMF QA Review Planning Form
- Topic:
- Data Monitoring / QA Records
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other
- Department:
- Function:
- Form
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 16/08/2024
- Title:
- MCTC001 Guidance | Creation of New Standard Operating Procedures
- Topic:
- Other Governance Protocol
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Melbourne Children's Trials Centre Data Management
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 2.0
- Date of Publication:
- 26/09/2022
- Title:
- MCTC014 Guidance | Filing definitions and Principles
- Topic:
- Data Records Reporting Staff Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Quality Assurance Other N/A
- Department:
- Function:
- Guidance
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.0
- Date of Publication:
- 02/03/2022
- Title:
- MCTC121 SOP | Document Management and Version Control
- Topic:
- Records Other
- Applicability:
- N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Iona Walton (Project Officer)
- Version #:
- 2.0
- Date of Publication:
- 12/06/2024
- Title:
- MCTC076 Guidance | Electronic file naming conventions
- Topic:
- Data Records Software Other
- Applicability:
- N/A
- Department:
- Function:
- Guidance
- Author:
- Iona Walton (Project Officer)
- Version #:
- 2.0
- Date of Publication:
- 18/01/2024
- Title:
- MCTC039 Template | Study Level Close Out Visit Report and Checklist
- Topic:
- Reporting Records Other
- Applicability:
- N/A
- Department:
- Function:
- Template
- Author:
- Laura Galletta (MCTC)
- Version #:
- 3.0
- Date of Publication:
- 04/10/2024
- Title:
- MCTC098 Template | Wet-Ink Signature Log
- Topic:
- Software Records Staff Other
- Applicability:
- N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 17/11/2020
- Title:
- MCTC089 Form | Data access application
- Topic:
- Data Consent Sponsorship
- Applicability:
- N/A
- Department:
- Function:
- Form
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 11/09/2020
- Title:
- MCTC090 Form | Transfer of Data
- Topic:
- Sponsorship Data Records
- Applicability:
- N/A
- Department:
- Function:
- Form
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 11/09/2020
- Title:
- MCTC092 Form | Data Request Review
- Topic:
- Sponsorship Data Monitoring / QA Records Other
- Applicability:
- N/A
- Department:
- Function:
- Form
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 11/09/2020
- Title:
- MCTC091 Form | Data Sharing Plan
- Topic:
- Data Other Sponsorship Records
- Applicability:
- N/A
- Department:
- Function:
- Form
- Author:
- MCTC (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 11/09/2020
- Title:
- MCTC111 Template | SOP External
- Topic:
- Other Monitoring / QA
- Applicability:
- N/A
- Department:
- Function:
- Template
- Author:
- Stephanie Firth (Project Officer)
- Version #:
- 1.3
- Date of Publication:
- 12/04/2023
- Title:
- MCTC061 SOP | Continuous improvement: A Corrective and Preventative Action (CAPA) Plan
- Topic:
- Safety Reporting Monitoring / QA Other
- Applicability:
- Intervention: drug/device Intervention: no drug/device Observational Other N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC080 Template | CAPA Plan
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC081 Template | CAPA Tracking Log
- Topic:
- Monitoring / QA Safety Other Reporting
- Applicability:
- Intervention: drug/device Intervention: no drug/device Other N/A
- Department:
- Function:
- Template
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 07/03/2019
- Title:
- MCTC088 Work Instructions | Setting up a Document for Digital Signing
- Topic:
- Software Other
- Applicability:
- N/A
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 1.1
- Date of Publication:
- 19/08/2020
- Title:
- MCTC100 Policy | Florence User Policy
- Topic:
- Software Governance Other
- Applicability:
- N/A
- Department:
- Function:
- Policy
- Author:
- MCTC (MCTC)
- Version #:
- 3.0
- Date of Publication:
- 22/08/2023
- Title:
- MCTC113 Guidance | Florence User Roles and Permissions
- Topic:
- Software
- Applicability:
- N/A
- Department:
- Function:
- Guidance
- Author:
- MCTC (MCTC)
- Version #:
- 13.0
- Date of Publication:
- 30/09/2022
- Title:
- MCTC130 Workflow | Accessing Florence eBinders Training
- Topic:
- Software Staff Other
- Applicability:
- N/A
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 4.0
- Date of Publication:
- 25/10/2022
- Title:
- MCTC162 Workflow | Auto-forward Emails in Florence
- Topic:
- Software Records Data Other
- Applicability:
- N/A
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 15/09/2022
- Title:
- MCTC161 Workflow | Florence eLog Management
- Topic:
- Software Other
- Applicability:
- N/A
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 15/09/2022
- Title:
- MCTC129 Workflow | Adding a New User to Florence
- Topic:
- Sponsorship Staff Other
- Applicability:
- N/A
- Department:
- Function:
- Work Instructions
- Author:
- CRDO (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 24/02/2021
- Title:
- MCTC160 Work Instruction | How to self-assign Ethics and Governance course MCRI
- Topic:
- Ethics Staff Other
- Applicability:
- Other N/A
- Department:
- Function:
- Work Instructions
- Author:
- Iona Walton (MCTC)
- Version #:
- 1.0
- Date of Publication:
- 28/04/2023
- Title:
- CEBU | REDCap Project User Management (non-trial specific)
- Topic:
- Data Software
- Applicability:
- N/A
- Department:
- Clinical Epidemiology & Biostatistics (CEBU)
- Function:
- Standard Operating Procedure
- Author:
- Luke Stevens (Research Data Systems Manager, CEBU)
- Version #:
- 1.0
- Date of Publication:
- 06/05/2022
- Title:
- CEBU | REDCap Project Change Control (non-trial specific)
- Topic:
- Data Software
- Applicability:
- N/A
- Department:
- Clinical Epidemiology & Biostatistics (CEBU)
- Function:
- Standard Operating Procedure
- Author:
- Luke Stevens (Research Data Systems Manager, CEBU)
- Version #:
- 1.0
- Date of Publication:
- 06/05/2022
- Title:
- MCTC201 SOP | METIS Management
- Topic:
- Monitoring / QA Other
- Applicability:
- N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Iona Walton (CRDO Officer)
- Version #:
- 0.1
- Date of Publication:
- 22/05/2024
- Title:
- MCTC178 Factsheet | eSigantures and Digital Signatures
- Topic:
- Software Other
- Applicability:
- Other N/A
- Department:
- Function:
- Factsheet
- Author:
- Iona Walton (CRDO )
- Version #:
- 1.0
- Date of Publication:
- 07/06/2024
- Title:
- MCTC194a SOP | Trial-Specific Qualification, Education, and Training – Clinical Trials Team Members
- Topic:
- Records Staff Other
- Applicability:
- Intervention: no drug/device N/A
- Department:
- Function:
- Standard Operating Procedure
- Author:
- Sarah Rathjen (Project Officer – Education and Training Coordinator)
- Version #:
- 1.1
- Date of Publication:
- 22/11/2024
- Title:
- MCTC213 Workflow | Using multiple Florence teams
- Topic:
- Applicability:
- N/A
- Department:
- Function:
- Work Instructions
- Author:
- Iona Walton (CRDO)
- Version #:
- 1.0
- Date of Publication:
- 12/09/2024