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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 Qualitative 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 Qualitative 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 Qualitative 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 #:
4.0
Date of Publication:
29/11/2019
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:
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 #:
2.0
Date of Publication:
14/04/2020
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 Qualitative 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 Qualitative 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 Qualitative 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 #:
0.2
Date of Publication:
24/01/2023
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 Qualitative 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:
MCTC039 Form | Study closure checklist
Topic:
Governance Reporting Records Other
Applicability:
Quality Assurance Qualitative Observational Intervention: drug/device Intervention: no drug/device Other
Department:
Function:
Form
Author:
CRDO (CRDO)
Version #:
1.0
Date of Publication:
20/03/2017
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:
CRDO (CRDO)
Version #:
1.0
Date of Publication:
05/08/2022
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 Sand Alone Sites
Topic:
Ethics Governance Other Approvals
Applicability:
Intervention: no drug/device Observational Intervention: drug/device Qualitative 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 Qualitative 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 Qualitative 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:
CRDO (CRDO)
Version #:
2.0
Date of Publication:
22/03/2021
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 Qualitative
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 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 Charter | MCRI Sponsorship Committee
Topic:
Sponsorship
Applicability:
Intervention: drug/device Intervention: no drug/device Other Observational
Department:
Function:
Policy
Author:
CRDO (CRDO)
Version #:
1.0
Date of Publication:
21/03/2023
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:
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 Qualitative 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 Guidance | Florence Period Review
Topic:
Monitoring / QA Reporting
Applicability:
Intervention: drug/device Intervention: no drug/device Observational Other
Department:
Function:
Guidance
Author:
Iona Walton (MCTC)
Version #:
1.0
Date of Publication:
22/08/2023
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
Applicability:
Intervention: drug/device Intervention: no drug/device Other Quality Assurance Observational
Department:
Function:
Guidance
Author:
Laura Galletta (MCTC)
Version #:
1.0
Date of Publication:
19/09/2023
Title:
MCTC195 Template | Data Management Plan
Topic:
Data
Applicability:
Intervention: drug/device Intervention: no drug/device
Department:
Function:
Template
Author:
Richard Hall (MCTC Data Officer)
Version #:
1.0
Date of Publication:
19/12/2023
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:
MCTC071 Guidance | eInvestigator Site File Filing (eISF) for MCRI sponsored clinical trials
Topic:
Other
Applicability:
Intervention: drug/device Intervention: no drug/device Observational Qualitative 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 Qualitative 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 Qualitative 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 Qualitative 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 Qualitative 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 Qualitative 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 #:
0.2
Date of Publication:
24/01/2023
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 Qualitative 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:
MCTC039 Form | Study closure checklist
Topic:
Governance Reporting Records Other
Applicability:
Quality Assurance Qualitative Observational Intervention: drug/device Intervention: no drug/device Other
Department:
Function:
Form
Author:
CRDO (CRDO)
Version #:
1.0
Date of Publication:
20/03/2017
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:
CRDO (CRDO)
Version #:
1.0
Date of Publication:
05/08/2022
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 Sand Alone Sites
Topic:
Ethics Governance Other Approvals
Applicability:
Intervention: no drug/device Observational Intervention: drug/device Qualitative 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 Qualitative 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 Qualitative 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:
CRDO (CRDO)
Version #:
2.0
Date of Publication:
22/03/2021
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 Qualitative
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 Charter | MCRI Sponsorship Committee
Topic:
Sponsorship
Applicability:
Intervention: drug/device Intervention: no drug/device Other Observational
Department:
Function:
Policy
Author:
CRDO (CRDO)
Version #:
1.0
Date of Publication:
21/03/2023
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:
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 Qualitative 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 Guidance | Florence Period Review
Topic:
Monitoring / QA Reporting
Applicability:
Intervention: drug/device Intervention: no drug/device Observational Other
Department:
Function:
Guidance
Author:
Iona Walton (MCTC)
Version #:
1.0
Date of Publication:
22/08/2023
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
Applicability:
Intervention: drug/device Intervention: no drug/device Other Quality Assurance Observational
Department:
Function:
Guidance
Author:
Laura Galletta (MCTC)
Version #:
1.0
Date of Publication:
19/09/2023
Title:
MCTC195 Template | Data Management Plan
Topic:
Data
Applicability:
Intervention: drug/device Intervention: no drug/device
Department:
Function:
Template
Author:
Richard Hall (MCTC Data Officer)
Version #:
1.0
Date of Publication:
19/12/2023
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:
MCTC071 Guidance | eInvestigator Site File Filing (eISF) for MCRI sponsored clinical trials
Topic:
Other
Applicability:
Intervention: drug/device Intervention: no drug/device Observational Qualitative 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 Qualitative 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 Qualitative 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 Qualitative 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 Qualitative 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 Qualitative 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 #:
0.2
Date of Publication:
24/01/2023
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 Qualitative 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:
MCTC039 Form | Study closure checklist
Topic:
Governance Reporting Records Other
Applicability:
Quality Assurance Qualitative Observational Intervention: drug/device Intervention: no drug/device Other
Department:
Function:
Form
Author:
CRDO (CRDO)
Version #:
1.0
Date of Publication:
20/03/2017
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 Sand Alone Sites
Topic:
Ethics Governance Other Approvals
Applicability:
Intervention: no drug/device Observational Intervention: drug/device Qualitative 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 Qualitative 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 Qualitative 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:
CRDO (CRDO)
Version #:
2.0
Date of Publication:
22/03/2021
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 Qualitative
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 Charter | MCRI Sponsorship Committee
Topic:
Sponsorship
Applicability:
Intervention: drug/device Intervention: no drug/device Other Observational
Department:
Function:
Policy
Author:
CRDO (CRDO)
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 Qualitative 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:
MCTC189 Guidance | Florence Period Review
Topic:
Monitoring / QA Reporting
Applicability:
Intervention: drug/device Intervention: no drug/device Observational Other
Department:
Function:
Guidance
Author:
Iona Walton (MCTC)
Version #:
1.0
Date of Publication:
22/08/2023
Title:
MCTC187 Guidance | Clinical Trial Decision Tool
Topic:
Protocol Sponsorship Other
Applicability:
Intervention: drug/device Intervention: no drug/device Other Quality Assurance Observational
Department:
Function:
Guidance
Author:
Laura Galletta (MCTC)
Version #:
1.0
Date of Publication:
19/09/2023
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:
MCTC071 Guidance | eInvestigator Site File Filing (eISF) for MCRI sponsored clinical trials
Topic:
Other
Applicability:
Intervention: drug/device Intervention: no drug/device Observational Qualitative 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 Qualitative 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 Qualitative 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 Qualitative 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 Qualitative 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 Qualitative Quality Assurance Other
Department:
Function:
Factsheet
Author:
CRDO (CRDO)
Version #:
1.0
Date of Publication:
19/04/2021
Title:
MCTC056 Form | Checklist for Trial development and Start-up
Topic:
Approvals Governance Other
Applicability:
Intervention: drug/device Intervention: no drug/device Observational Qualitative Other
Department:
Function:
Form
Author:
CRDO (CRDO)
Version #:
2.0
Date of Publication:
09/08/2021
Title:
MCTC039 Form | Study closure checklist
Topic:
Governance Reporting Records Other
Applicability:
Quality Assurance Qualitative Observational Intervention: drug/device Intervention: no drug/device Other
Department:
Function:
Form
Author:
CRDO (CRDO)
Version #:
1.0
Date of Publication:
20/03/2017
Title:
MCTC043 Flowchart | Ethics & Governance Process for Sand Alone Sites
Topic:
Ethics Governance Other Approvals
Applicability:
Intervention: no drug/device Observational Intervention: drug/device Qualitative 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 Qualitative Other
Department:
Function:
Work Instructions
Author:
CRDO (CRDO)
Version #:
2.0
Date of Publication:
10/10/2017
Title:
MCTC070 Guidance | eSIF Filing Guidelines
Topic:
Data Monitoring / QA Records Other Software
Applicability:
Intervention: drug/device Intervention: no drug/device Observational Qualitative Other
Department:
Function:
Guidance
Author:
CRDO (CRDO)
Version #:
1.1
Date of Publication:
01/06/2021
Title:
MCTC108 Template | Data Protection Checklist
Topic:
Approvals Consent Ethics Data Records Other
Applicability:
Intervention: drug/device Intervention: no drug/device Observational Qualitative
Department:
Function:
Template
Author:
MCTC (MCTC)
Version #:
1.0
Date of Publication:
19/04/2021
Title:
MCTC054.01 Template | Sample Tracking and Processing Log
Topic:
Records Safety Staff Other
Applicability:
Intervention: drug/device Intervention: no drug/device Observational Qualitative Quality Assurance Other
Department:
Bio-Banking Facility
Function:
Template
Author:
Iona Walton (MCTC)
Version #:
1.0
Date of Publication:
19/05/2023
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:
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 Qualitative 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 Qualitative 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 Qualitative 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 Qualitative 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 Qualitative 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 Qualitative Quality Assurance Other
Department:
Function:
Factsheet
Author:
CRDO (CRDO)
Version #:
1.0
Date of Publication:
19/04/2021
Title:
MCTC039 Form | Study closure checklist
Topic:
Governance Reporting Records Other
Applicability:
Quality Assurance Qualitative Observational Intervention: drug/device Intervention: no drug/device Other
Department:
Function:
Form
Author:
CRDO (CRDO)
Version #:
1.0
Date of Publication:
20/03/2017
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 Qualitative Quality Assurance Other
Department:
Bio-Banking Facility
Function:
Template
Author:
Iona Walton (MCTC)
Version #:
1.0
Date of Publication:
19/05/2023
Title:
MCTC187 Guidance | Clinical Trial Decision Tool
Topic:
Protocol Sponsorship Other
Applicability:
Intervention: drug/device Intervention: no drug/device Other Quality Assurance Observational
Department:
Function:
Guidance
Author:
Laura Galletta (MCTC)
Version #:
1.0
Date of Publication:
19/09/2023
Title:
MCTC071 Guidance | eInvestigator Site File Filing (eISF) for MCRI sponsored clinical trials
Topic:
Other
Applicability:
Intervention: drug/device Intervention: no drug/device Observational Qualitative 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 Qualitative 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 Qualitative 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 #:
2.0
Date of Publication:
14/04/2020
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 Qualitative 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 Qualitative 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 Qualitative 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 #:
0.2
Date of Publication:
24/01/2023
Title:
MCTC056 Form | Checklist for Trial development and Start-up
Topic:
Approvals Governance Other
Applicability:
Intervention: drug/device Intervention: no drug/device Observational Qualitative 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:
MCTC039 Form | Study closure checklist
Topic:
Governance Reporting Records Other
Applicability:
Quality Assurance Qualitative Observational Intervention: drug/device Intervention: no drug/device Other
Department:
Function:
Form
Author:
CRDO (CRDO)
Version #:
1.0
Date of Publication:
20/03/2017
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 Sand Alone Sites
Topic:
Ethics Governance Other Approvals
Applicability:
Intervention: no drug/device Observational Intervention: drug/device Qualitative 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 Qualitative 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 Qualitative 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:
CRDO (CRDO)
Version #:
2.0
Date of Publication:
22/03/2021
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 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 Charter | MCRI Sponsorship Committee
Topic:
Sponsorship
Applicability:
Intervention: drug/device Intervention: no drug/device Other Observational
Department:
Function:
Policy
Author:
CRDO (CRDO)
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:
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 Qualitative 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 Guidance | Florence Period Review
Topic:
Monitoring / QA Reporting
Applicability:
Intervention: drug/device Intervention: no drug/device Observational Other
Department:
Function:
Guidance
Author:
Iona Walton (MCTC)
Version #:
1.0
Date of Publication:
22/08/2023
Title:
MCTC187 Guidance | Clinical Trial Decision Tool
Topic:
Protocol Sponsorship Other
Applicability:
Intervention: drug/device Intervention: no drug/device Other Quality Assurance Observational
Department:
Function:
Guidance
Author:
Laura Galletta (MCTC)
Version #:
1.0
Date of Publication:
19/09/2023
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 Qualitative Quality Assurance Other N/A
Department:
Function:
Guidance
Author:
Stephanie Firth (Project Officer)
Version #:
1.0
Date of Publication:
02/03/2022
Title:
MCTC073 Factsheet | Monitoring using Parkville Connect
Topic:
Monitoring / QA
Applicability:
N/A
Department:
Function:
Factsheet
Author:
Stephanie Firth (Project Officer)
Version #:
1.0
Date of Publication:
05/08/2022
Title:
MCTC002 SOP | Copying and Certifying Essential Documents
Topic:
Records
Applicability:
Intervention: drug/device Intervention: no drug/device Observational Qualitative 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:
MCTC087 Guidance | Trial Personnel Responsibilities, Training and Evidence of Qualification for Investigator-Initiated Trials (IITs)
Topic:
Records Safety Other Staff
Applicability:
N/A
Department:
Function:
Guidance
Author:
CRDO (CRDO)
Version #:
1.0
Date of Publication:
19/08/2020
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:
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:
MCTC071 Guidance | eInvestigator Site File Filing (eISF) for MCRI sponsored clinical trials
Topic:
Other
Applicability:
Intervention: drug/device Intervention: no drug/device Observational Qualitative 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 Qualitative 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 Qualitative 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: