Good Clinical Practice
What is GCP?
According to the US Food and Drug Administration, GCP “…is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and wellbeing of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.”
GCP is described in a European Union document E6 Good Clinical Practice: Consolidated Guidance which was published in 1996. EU Directives in 2005 (2005/28/EC) updated some aspects of the document, but the principles remained the same.
The principles of GCP
- Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
- Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
- The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
- The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
- Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
- A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favorable opinion.
- The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
- Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
- Freely given informed consent should be obtained from every subject prior to clinical trial participation.
- All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification.
- The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
- Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
- Systems with procedures that assure the quality of every aspect of the trial should be implemented.
The ICH E6 document can be downloaded from:
The Australian TGA: This version of the document has been annotated by the TGA to reflect the specific regulatory environment in Australia.
The document is also available from:
http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html
Some abbreviations (from the E6 glossary)
IRB – Institutional Review Board
An independent body constituted of medical, scientific, and nonscientific members, whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trials, of protocols and amendments, and of the methods and materials to be used in obtaining an documenting informed consent of the trial subjects.
IEC – Independent ethics committee
An independent body (a review board or a committee, institutional, regional, national or supranational), constituted of medical/scientific professionals and nonmedical/nonscientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things reviewing and approving/providing favourable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
These materials are based on content originally provided by the WOMBAT collaboration. The WOMBAT Collaboration was formed to promote and support high quality randomised clinical trials in the perinatal area in order to improve the health and wellbeing of women and their children (2005 – 2010).
Prepared by Rebecca Tooher (WOMBAT) in 2008 and updated by Lucille Sebastian (NHMRC CTC) in 2015
Last revised: 24 June 2015