Updates
New SOP alert!
MCTC032 SOP | Archiving in Florence eBinders
This SOP describes the process and procedures when archiving clinical trial and observational research binders that are stored and maintained within the Florence eBinder™ platform, for both Externally Sponsored and Investigator-Initiated Trials conduct at the Melbourne Children's Campus.
This SOP has been created to support the archiving procedure at MCRI as detailed in MCTC170 SOP | Archiving Clinical Trial Investigator Site Files
Updated templates for SOPs, Guidance and Work Instructions.
Find new templates with MCC logo available at:
Updated SOP alert!
MCTC194a SOP | Trial-Specific Qualification, Education, and Training - Clinical Trial Staff
This updated SOP now includes ancillary staff involved in trials. It's purpose is to:
Define the necessary qualifications and training required of members of multidisciplinary Clinical Trials Team members involved in developing, conducting, and providing services to clinical trials across the Melbourne Children’s Campus (MCC).
Ensure that there is documentary evidence that team members have the required qualifications and training to successfully perform in their role as a member of the Clinical Trials Team
Ensure there is a process for Clinical Trials Team members to maintain currency of qualifications, and training.
A whole suit of new and updated work instructions and templates have also been developed for all of the documents outlined in the SOP:
Updated Guidance alert!
MCTC001 Guidance | Creation of New Standard Operating Procedures, Guidance and Work Instructions
This Guidance has been updated to not only provide a procedure for developing new SOPs but now also includes Guidance documents and work instructions, for the purpose of standardising and improving the quality of procedures in human participant research.
A whole suit of new and updated templates have been developed for all of the documents outlined in the guideline, including an MCTC glossary:
New SOP alert!
MCTC084 SOP | Trial Master File (TMF) Quality Assurance
This SOP describes the activities required to prepare, initiate, conduct, and report on Trial Master File (TMF) reviews for quality assurance (QA) and quality control (QC) purposes.
A whole suit of documents have also been developed for this process, to complete it and guide those who undertake a QA review:
Our new MCTC189 SOP | Trial Close Out for IITs is here.
The purpose of this SOP is to describe the procedures related to the close-out of an MCRI
sponsored investigator initiated clinical trial, both at a site level and at a study level, to ensure all
required actions are completed prior to final analysis.
All MCRI sponsored investigator initiated clinical trials must be closed out in accordance with this
Standard Operating Procedure (SOP).
Find it at: https://metis.melbournechildrens.com/MCTC189
The Clinical Trial DMP has gone live!
This DMP template is based on the Society of Clinical Data Management (SCDM) definition of a Data Management Plan as a document that “comprehensively documents data and its handling from definition, collection and processing to final archival or disposal.” It is compliant with GCP and NHMRC expectations for such a document and will hopefully be adaptable for the widest possible range of trials.
Find it here: https://metis.melbournechildrens.com/MCTC195
A new SOP has been published!
MCTC037b SOP | Sponsorship Committee Process for IITs
This Standard Operating Procedure (SOP) describes the process and activities taken by the
Sponsor-Investigator and trial team seeking Murdoch Children’s Research Institute (MCRI)
sponsorship of an Investigator Initiated Trial (IIT).
Find it at: https://metis.melbournechildrens.com/MCTC037b
A new SOP has been published!
MCTC166 SOP | Management of Investigational Product.
This SOPs purpose is to document the procedures for the management of Investigational Medicinal Product (IMP) used in research involving human participants, following dispensing from Clinical Trials Pharmacy.
Find it at: https://metis.melbournechildrens.com/MCTC166
A new SOP has been published!
MCTC054 SOP | Handling, Processing, Storage and Transport of Biospecimens in Human Research.
This SOP covers the general processes related to the safe handling, processing, storage and
transport of research biospecimens category B (such as blood, urine, tissue, sputum, faeces).
When references to biospecimens/biological samples/substances are made, category B is
implied.
Find it at: https://metis.melbournechildrens.com/MCTC054
A biospecimens sample tracking and processing log has also been developed and released to support the use of this SOP. Found here: https://metis.melbournechildrens.com/MCTC05401
A new SOP has been published!
MCTC164 SOP | Management of Temperature Controlled Storage
This SOP details the procedure for the management of the storage of biological samples and other temperature sensitive clinical trial products in the Melbourne Children’s Research Unit (MCRU) temperature-controlled storage units (freezer(s) and refrigerator(s)). The purpose of the procedure is to ensure the integrity of the stored items.
Find it at: https://metis.melbournechildrens.com/MCTC164
Two new SOPs have just been published: MCTC182 and MCTC183.
MCTC182: Sponsor-Investigator Responsibilities in MCRI-Sponsored IITs - This SOP defines the Sponsor responsibilities when delegated the roles and responsibilities of an MCRI-sponsored IIT, where the Sponsor-Investigator is acting in the capacity of sponsor.
Find it at: https://metis.melbournechildrens.com/MCTC182
MCTC183: Delegation of Sponsor Responsibilities in MCRI-Sponsored IITs - The purpose of this SOP is to describe the standard operating procedure for the delegation of responsibilities within single-site and multi-site investigator-initiated trials
Find it at: https://metis.melbournechildrens.com/MCTC183
An SOP update has just been published.
MCTC065 SOP | Study Start Up for Clinical Trials version 2.0 has just been uploaded. This is an update to the pervious SOP published in 2020.
Find it at: https://metis.melbournechildrens.com/MCTC065