Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research.

High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software. Quality assurance and inspections ensure that these standards are achieved. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented.

GCP guidelines[1] include protection of human rights for the subjects and volunteers in a clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. GCP guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of institutional review boards, clinical research investigators, clinical trial sponsors, and monitors. In the pharmaceutical industry monitors are often called clinical research associates.

A series of unsuccessful and ineffective clinical trials in the past were the main reason for the creation of ICH and GCP guidelines in the US and Europe. These discussions ultimately led to the development of certain regulations and guidelines, which evolved into the code of practice for international consistency of quality research.

Legal and regulatory status

ICH GCP overview


GCP has been called 'a less morally authoritative document' than the Declaration of Helsinki, lacking moral principles and guidance in the following areas:[5]

In the book Bad Pharma, Ben Goldacre mentions these criticisms and notes that the GCP rules "aren't terrible... [they are] more focused on procedures, while Helsinki clearly articulates moral principles".[6]

See also


  1. ^ "ICH Official web site : ICH". Retrieved 2021-11-24.
  2. ^
  3. ^ Commissioner, Office of the. "Clinical Trials and Human Subject Protection". Retrieved 2018-11-01.
  4. ^ "Good Clinical Practice Training |". Retrieved 2020-04-03.
  5. ^ Kimmelman, Jonathan; Weijer, Charles; Meslin, Eric M (2009). "Helsinki discords: FDA, ethics, and international drug trials". The Lancet. 373 (9657): 13–14. doi:10.1016/S0140-6736(08)61936-4. PMID 19121708.
  6. ^ Ben Goldacre (2012). Bad Pharma. London: Fourth Estate. OL 25682902M.