Good clinical practice

Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.

Good Clinical Practice guidelines include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds.

Good Clinical Practice Guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry monitors are often called Clinical Research Associates.

ICH GCP overview

* Guidelines for the investigator
* Guidelines for the trial sponsor (industrial, academic)
* Guidelines for the clinical trial protocol and protocol amendments
* Guidelines for the Investigator's brochure

See also

* GxP
* Clinical site
* Drug development
* Institutional Review Board
* Data Monitoring Committees
* Directive 2001/20/EC (European Union)
* European Medicines Agency (EMEA)
* Japan Ministry of Health
* Medical ethics
* Pharmacovigilance
* EudraVigilance
* European Forum for Good Clinical Practice (EFGCP)
* Pharmaceutical company

External links

*ICH Topic E 6 (R1) [http://www.emea.europa.eu/pdfs/human/ich/013595en.pdf Guideline for Good Clinical Practice]
* [http://www.fda.gov/oc/gcp/default.htm Good Clinical Practice] (from U.S. Food and Drug Administration)
*Some Relevant UK Statutory Instruments
** [http://www.opsi.gov.uk/si/si2004/20041031.htm The Medicines for Human Use (Clinical Trials) Regulations 2004]
** [http://www.opsi.gov.uk/si/si2006/20061928.htm The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006]
** [http://www.opsi.gov.uk/si/si2006/20062984.htm The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006]