Good Clinical Practice (GCP) for clinical trials in Australia

Australia has adopted international guidelines that outline good clinical practice when conducting human research. Learn about the development of these guidelines, including which ones apply in Australia.

International guidelines

The principles of Good Clinical Practice (GCP) have their origin in the World Medical Association’s Declaration of Helsinki. First published in 1964, the declaration responded to the revelations of the Nuremberg trials conducted after World War II. Its drafters wanted to place the rights, safety and wellbeing of any human subjects involved in clinical research above all other considerations. The World Medical Association have revised the document several times.

The International Conference on Harmonisation (ICH) developed guidance for the conduct of clinical trials, based on the declaration. The guidance is known as the Good Clinical Practice guidelines, even though the guidelines apply to clinical research rather than clinical practice. The GCP guidelines set out the requirements for:

  • trial documentation
  • protocol amendments
  • indemnity
  • reporting lines for adverse events
  • provision of medical care for trial participants.

Australian guidelines

The Therapeutic Goods Administration (TGA) has adopted:

The National Standard Operating Procedures for Clinical Trials is based on the ICH Guideline for Good Clinical Practice (ICH E6 (R2)).

Ethical issues in human research

Complementing these guidelines is Australia’s National Statement on Ethical Conduct in Human Research. The national statement provides guidance on a wide range of ethical issues in human research and is intended for use by:

  • any researcher conducting research with human participants
  • any member of an ethics review body reviewing that research
  • those involved in research governance
  • potential research participants.

The national statement describes the overarching principles of ethical conduct in research, including the operations of Human Research Ethics Committees (HRECs).

The national statement requires that, before granting approval for a clinical trial, a HREC must be satisfied that the protocol conforms to:

GCP compliance

For more information on GCP compliance see the:

Date last updated:
  • Running clinical trials