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Barwon Health / Research

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Guidelines & Advice

Please note the Barwon Health Research Manual has been archived and will no longer be available. The manual has been superseded by the advice, SOPs and guidelines now available on the REGI Unit’s webpage on the Barwon Health website.

Guidelines for Applications

Guidelines for Research Conduct

Guidelines for Clinical Trials

Guidelines for Document Naming

Standard Operating Procedures for Streamlining Ethical Review

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.

REGI 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

Last Modified: Thursday, 14 January 2021