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
- reporting lines for adverse events
- provision of medical care for trial participants.
The Therapeutic Goods Administration (TGA) has adopted:
- the European Union version of the ICH Guideline for Good Clinical Practice in Australia, with notes from the TGA relevant to the Australian context
- other international guidelines related to clinical trials, including guidelines on clinical safety data management that cover expedited reporting of adverse drug reactions
- ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice.
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:
- the National Statement on Ethical Conduct in Human Research
- the World Medical Association’s Declaration of Helsinki
- where relevant, the
- any requirements of relevant Australian Government, and state or territory laws.
For more information on GCP compliance see the: