Clinical Trials

Please note the Barwon Health Research Manual has been archived and will no longer be available. The manual has been superseded by the advice, SOPs and guidelines now available on the RDU webpage on the Barwon Health website.

Guidelines for Applications

• Barwon Health HREC Applications
• Research Involving Greater than Low Risk
• Seeking Consent and Waiver of Consent
• Authorisation and Document Requirements for New Single-Site Applications
• Negligible Risk Single Site Application Guide
• Low Risk Single Site Application Guide
• Greater than Low Risk Single Site Application Guide

Guidelines for Research Conduct

• Handling Complaints in Research
• Managing Conflicts of Interest
• Data Storage and Archiving
• Privacy Guidelines
• Collaborative Research and Authorship
• Guidelines for Determining Co-Authorship for Biostatisticians
• Research Data and Records Management Policy

Guidelines for Clinical Trials

• Research Safety Monitoring and Reporting
• Research Involving Radiation Exposure of Human Volunteers

Guidelines for Document Naming

• Document Naming Guidelines

Standard Operating Procedures for Streamlining Ethical Review

• Streamlining Ethical Review of Research Projects (A practical guide for research co-ordinators on submitting ethics and governance for multi-site projects via Online Forms)

Standard Operating Procedures to Achieve Good Clinical Practice
All clinical trial research conducted under the auspices of Barwon Health and all research conducted in Australia, must comply with the Australian adopted version of ICH-GCP Guidelines (International Conference on Harmonisation CPMP/ICH/135/96 - annotated with TGA comments, July 2000).

The Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials.

The TGA has adopted CPMP/ICH/135/95 in principle, but has recognised that some elements are, by necessity, overridden by the National Statement (and therefore not adopted) and that others require explanation in terms of 'local regulatory requirements'.

Failure to conduct research in line with GCP guidelines contravenes the Australian regulatory framework and increases exposure to risk.

In 2007, the Victorian Managed Insurance Authority (VMIA) developed '13 SOPs' that aim to provide the necessary tool to ensure that researchers are able to conduct research to International Clinical Harmonisation/Good Clinical Practice (ICH-GCP) standards by efficiently providing operating documentation.

RDU and the Barwon Health Clinical Trial Advisory Committee (CTAC) endorse the Standard Operating Procedures (SOPs) developed by VMIA. We are currently reviewing and specifying the VMIA SOPs to align with Barwon Health processes.

Barwon Health researchers are encouraged to adopt these SOPs as part of their standard research practices and incorporate the SOPs into their departmental procedure manuals for undertaking research involving human participants.

The '13 SOPs' are:

• SOP 1: Documentation of Investigational Site Qualifications, Adequacy of Resources and Training Records
• SOP 2: Study Site Master File and Essential Documents
• SOP 3: Communication with HREC, Trial Sponsor and Insurer
• SOP 4: Protocol and Investigational Brochure Content, Design, Amendment and Compliance
• SOP 5: Receipt and Handling of Investigational Product
• SOP 6: Informed Consent Procedures and Writing Patient Informed Consent Forms
• SOP 7: Case Report Forms, Source Documents, Record Keeping and Archiving
• SOP 8: Site Initiation and Close Out
• SOP 9: TGA Notification and SAE Reporting Requirements
• SOP 10: Investigator Responsibilities
• SOP 11: Sponsor Responsibilities in Investigator Initiated Studies
• SOP 12: Handling and Shipping of Infectious Substances for Clinical Trials
• SOP 13: Standard Operating Procedure Creation, Implementation and Revision