Resources
Training and Methodological Experts
Australian Clinical Trials Education Centre (A-CTEC)
Provides training regarding clinical trials including good clinical practice (GCP) training.
More informationAustralian Clinical Trials Alliance (ACTA) Resources
Resource for webinars and articles on investigator initiated clinical trials.
More informationThe Methods and Implementation Support for Clinical and Health (MISCH) Hub
A collaborative platform with experts providing expertise in research methods to ensure high quality and impactful clinical and health research.
More informationClinical Epidemiology & Biostatistics (CEBU)
Promote high quality research by partnering with the Melbourne Children’s Campus to provide expert training and resources for clinical and public health researchers at all stages.
More informationHelpful Tools
Clinical Trial Planner
Created by Health Translation Queensland this tool supports trial planning with practical information and guidance.
More informationHealth Data Australia
A national catalogue for Australian health data for researchers to use and register datasets.
More informationLegal Agreement Templates
Medicines Australia Clinical Trial Research Agreements
Clinical Trial Research Agreement (CTRA) templates that are the standard template for use in clinical trials.
More informationMACH Research Collaboration Agreement
Research Collaboration Agreement (RCA) template for use in investigator-initiated non-sponsored projects.
More informationEssential Guidance
Therapeutic Goods Administration (TGA) Clinical Trial Handbook
Guidance on conducting clinical trials in Australia using 'unapproved' therapeutic goods.
More informationNational Statement on Ethical Conduct in Human Research
The National Statement provides a framework to ensure human research in Australia is carried out responsibly.
More informationSafety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods
Defines roles for monitoring and reporting clinical trial safety issues.
More informationmarra ngarrgoo, marra goorri - The Victorian Aboriginal Health, Medical and Wellbeing Research Accord
The vision of marra ngarrgoo, marra goorri is to align research with Aboriginal and Torres Strait Islander principles of self-determination.
More informationStandard Operating Procedures (SOPs) and Templates for University of Melbourne Sponsored Clinical Trials
The below are SOPs and templates for University of Melbourne sponsored clinical trials to ensure that tasks are completed consistently and correctly. Use of these documents is not mandatory. These SOPs and templates have been developed as a resource to support clinical trial teams and reduce the administrative burden where possible.
SOP-02 Delegation of Responsibilities for University of Melbourne Clinical Trials
To describe the procedures and requirements related to the delegation of Sponsor responsibilities from University of Melbourne.
SOP-03 Site Staff Qualifications, Training Records and Capability
Document staff qualifications and site resources to ensure compliance with ICH GCP and governance standards.
SOP-04 Protocol and Investigational Brochure Requirements
Outline procedures for developing research protocol, IB, and amendments ensuring compliance with ICH GCP E6(R2).
SOP-05 Communication with HREC, RGO, Sponsor and Institution’s Insurer
Procedures for communication with HREC, RGO, Sponsor and Insurer regarding research governance requirements.
SOP-06 Site Initiation
To describe the procedures related to site initiation of a clinical trial at all sites.
SOP-07 The Study Master File
To describe the procedures related to the maintenance of the Study Master File (SMF) held at all clinical research sites/units, according to ICH GCP E6 (R2) Section 8 to ensure it is current at all times for the duration of the clinical study.
SOP-08 Case Report Forms and Source Documents
To describe the procedures related to the completion of electronic and paper based Case Report Forms (CRF), and maintenance of Source Documents.
SOP-09 Participant Informed Consent Process and Documentation
Describe procedures and documentation for informed consent including telehealth to ensure voluntary informed decisions through ongoing communication.
SOP-10 Handling and Shipping of Biological Substances (Cat B) and Dangerous Goods
Explain safe handling and shipping of Biological Substances (Cat B) and/or Dangerous Goods and the rules involved.
SOP-11 Management of Investigational Product
Explain how to manage to managing all aspects of Investigational Product (IP) from delivery to preparation, storage and disposal.
SOP-12 Safety Data Monitoring and Reporting Requirements for Clinical Trials
Outline steps for collecting, checking, and reporting safety data in clinical trials.
SOP-13 Site Close-Out and Archiving
To describe the procedures related to close-out of a clinical trial at all sites and archiving of trial related documentation at the end of the clinical trial.
SOP-14 Data Sharing and Access Procedure for the Release of Data from University of Melbourne Sponsored Investigator-Initiated Clinical Trials
Explain how to share trial data with researchers outside of the University of Melbourne.
SOP-15 Document Management and Version Control
To provide the procedure for document management and control, including drafting, issue, filing and revision of clinical trial documents.
SOP-16 Clinical Trial Registration of Investigator-Initiated Trials
Guide researchers on registering clinical trials and keeping registry records updated to meet all requirements.
SOP-17 Copying and Certifying Essential Documents
Explain how to handle and keep official copies of important documents.
SOP-18 Establishing International Clinical Trials
Describe how to establish and oversee international trials following University and regulatory guidelines.
SOP-19 Regulatory Green Light Approval for Clinical Trial Site Activation
Guide on pre-trial checks, approvals and drug release for local and international studies.
SOP-20 Monitoring Visit Activities for Clinical Trials of Investigational Products_
Explain how to monitor clinical trials to meet safety and regulatory standards.
SOP-21 Study Start Up for Clinical Trials
Explains steps for starting University of Melbourne sponsored clinical trials from planning to site activation.
SOP-22 Continuous improvement A Corrective and Preventative Action (CAPA) Plan
How to develop a corrective and preventive action (CAPA) plan.
SOP-23 Obtaining Informed Written Consent from a Medical Treatment Decision Maker
Explains how researchers obtain written consent from a medical treatment decision maker.
SOP-24 Obtaining Informed Verbal Consent from a Medical Treatment Decision Maker
Describes the process for obtaining verbal consent from a medical treatment decision maker.
SOP-25 Obtaining Informed Consent to Continue
Describes how to confirm continued participation after emergency enrolment within a clinical trial.
SOP-26 Opt Out Consent Process
Explains the opt-out consent processes after a medical emergency enrolment as part of a clinical trial.
SOP-28 Audit Preparation and Process
Touches on audit preparation and the process researchers should follow when audited.
TEMPLATE 01 - Green Light Approval Form v1.0
Checklist for the essential documentation required prior to conducting the site initiation meeting.