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GCP, Research Ethics and Governance Standard Operating Procedures (SOP)

Australian ICH GCP (Including Teletrials) Standard Operating Procedures

This Compendium, including the SOPs, has been developed to incorporate the recommendations from the Clinical Oncology Society of Australia’s (COSA) Australasian Teleā€trial Model – A National Guide to Implementation. We gratefully acknowledge the input and review of these Chapters by our research community particularly the COSA Teletrials Consortium, Medicines Australia and its member organisations, Cooperative Clinical Trial Groups, COSA Queensland Health (QH) advisory group, QH State-Wide Teletrial Working Group, QH State-Wide Cancer Clinical Network and pilots at the Northern Cluster in Queensland and Orange/Dubbo Cluster in New South Wales. We also gratefully acknowledge the input from the Clinical Research Coordinator Network and other State Health jurisdictions, CROs and pharmaceutical company representatives.

Chapter 1 COSA Australasian Tele-trial model
Chapter 2 Glossary of Terms
Chapter 3 Australian ICH GCP SOPs

SOP 10 Standard Operating Procedure (SOP) Creation, Implementation and Revision

SOP 20 Investigator Responsibilities

SOP 30 Site Staff Qualifications, Training Records and Capability

SOP 40 Protocol and Investigational Brochure (IB) Requirements

SOP 50 Communication with Human Research Ethics Committee (HREC), Research Governance Office (RGO), Sponsor and Insurer

SOP 60 Site Initiation

SOP 70 The Study Site Master File

SOP 80 Case Report Forms and Source Documents

SOP 90 Participant Informed Consent

SOP 100 Handling and Shipping of Biological Substances in Clinical Trials

SOP 110 Management of Investigational Product

SOP 120 Safety Data Monitoring and Reporting Requirements for Clinical Trials

SOP 130 Site Close Out and Archiving

Chapter 4 List of Key Guidance Documents

Chapter 5 Teletrial Clinical Consultation User Guide

Last updated: 10 April 2019