Good clinical practices

Clinical trials must be conducted in accordance with the principles of Good Clinical Practice (GCP). GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Its purpose is twofold  

A harmonised guidance document on GCP has been developed by the ICH (ICH E6). The core principles of GCP, as agreed in the guidance document, are outlined in Table 5.2. 

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Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. 

Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products... 

Table 5.2 The core principles of Good Clinical Practice.

E5(R1) Ethnic Factors in the Acceptability of Foreign Clinical Data Good Clinical Practice E6(R1) Good Clinical Practice... 

VICH guideline GL9 sets out the principles of Good Clinical Practices for clinical trials of veterinary medicines. The guideline has not been incorporated into specific... 

FDA resources are expended in areas based not on their absolute importance but on the lack of industry capability to control a particular concern. When manufacturing processes were primitive, unclean, and uncontrolled, the FDA issued the Good Manufacturing Practices and eventually the Good Laboratory Practices, Good Clinical Practices, and Good Tissue Practices. Together these Practices provide standards for the industry operations. 

U S Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research. Center for Biologies Evaluation and Research. Guidelines for industry Good clinical practice consolidated guidance. 1996. Rockville Maryland. 

WHO Guidelines for Good Clinical Practice for trials on pharmaceutical products. 

GMP = good manufacturing practice GCP = good clinical practice. 

In the FDA s Guidance for Industry E6 Good Clinical Practice Consolidated Guidance, an adverse event is defined as follows ... 

Good Clinical Practices, Clinical Safety Data Management)... 

Barton, B. (1998). International Conference on Harmonization good clinical practices update. Drug Information J. 32 1143-1147. 

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