The principles of Good Clinical Practice (GCP) have their origin in the World Medical Association’s Declaration of Helsinki. The Declaration of Helsinki was responsive to the revelations of the Nuremberg trials conducted after World War II, and its drafters sought to ensure that human subjects involved in clinical research would, in future, have their rights, safety and well-being placed above all other considerations in clinical research. The document has been revised several times since it was first published in 1964.
The Declaration of Helsinki was used as a basis for the development of guidance for the conduct of clinical trials by the International Conference on Harmonisation (ICH). Originally developed for commercially sponsored late phase drug trials, this guidance has become known as the GCP guidelines, even though the guidelines apply to clinical research rather than clinical practice. The GCP guidelines detail the requirements for trial documentation, protocol amendments, requirements such as indemnity, reporting lines for adverse events and provision of medical care for trial participants.
The Therapeutic Goods Administration (TGA) has adopted the European Union version of these guidelines in Australia. The TGA advice includes specific comments from the TGA relevant to the Australian context. Several other guideline documents provide additional helpful advice with respect to clinical trial issues. Of particular note is the Note for guidance on clinical safety data management: definitions and standards for expedited reporting, which describes the reporting processes for expedited reporting of adverse drug reactions in clinical trials.
The TGA has also adopted ISO 14155 Clinical Investigation of medical devices for human subjects – Good clinical practice. ISO 14155:2011 articulates standards for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.
Complementing these guidance documents is Australia’s National Statement on Ethical Conduct in Human Research, published by the NHMRC. The National Statement provides guidance on a wide range of ethical issues in human research. It describes the overarching principles of ethical conduct in research, but also provides guidance for specific types of research, specific instructions for the formation and operation of human research ethics committees, advice regarding consideration of multi-centre research and specific issues for HRECs to consider when reviewing a clinical trial proposal.
The National Statement requires that, before granting approval to a clinical trial, a Human Research Ethics Committee (HREC) must be satisfied that the protocol conforms to:
- the National Statement
- the World Medical Association Declaration of Helsinki
- where relevant, the CPMP/ICH Note for Guidance on Good Clinical Practice (CPMP/ICH-135/95), the ISO 14155 Clinical Investigation of Medical Devices and the requirements of the TGA
- any requirements of relevant Commonwealth or state/territory laws.’
For further information on GCP compliance see The Australian Clinical Trial Handbook: A simple, practical guide to the conduct of clinical trials to International standards of Good Clinical Practice (GCP) in the Australian context and the Australian Code for the Responsible Conduct of Research, which provides guidance to institutions and researchers regarding responsible research practices and promotes integrity in research.