Good clinical practice guidelines

Clinical trials involve different phases of studies of the drug. The aim of clinical trials is to assess safety and efficacy of a drug in humans. Clinical trials must follow good clinical practice guidelines. 

Compliance with the ICH Good Clinical Practice Guidelines (incorporates the Declaration of Helsinki) or equivalent should be required. 

Investigator s Brochure Conformity with the International Conference on Harmonization Good Clinical Practice Guideline for the... 

According to the International Committee on Harmonization and Good Clinical Practice guidelines (ICH/GCP), in the preapproval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic... 

Good clinical practice guidelines apply, e.g Association of British Pharmaceutical... 

The International Committee on Harmonization (ICH) Good Clinical Practice guidelines E6(R1), EDA Regulations relating to good clinical practice and clinical trials (CER 21), and EDA Good Laboratory Practice guidelines may be helpful references. New projects that use an established biorepository are submitted for determination of review status (e.g., exempt, expedited, full board review). 

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... 

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... 

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. 

ICH Harmonized Tripartite Guideline for Good Clinical Practice (Table 6.1 shows the ICH documents related to clinical trials)... 

ICH Harmonized Tripartite Guideline for Good Clinical Practice ... 

Source International Conference on Harmonization. Guideline for Good Clinical Practice E6(R1). http //www.ich.org/LOB/media/MEDIA482.pdf [accessed September 17,2007]. 

Two other documents are relevant to clinical trials the World Health Organisation (WHO) Guidelines for Good Clinical Practice for trials on pharmaceutical products, still used for clinical trials in some parts of the world, and the new EU Clinical Trial Directive. ... 

International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH). Topic E6 Note for Guidance on Good Clinical Practice Consolidated Guideline, CPMP/ICH/135/95. London European Agency for the Evaluation of Medicinal Products, 1996. 

World Health Organization (WHO). Technical Report Series, No. 850. Annex 3 Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products. Geneva, Switzerland World Health Organization, 1995 (Modified 2000). 

Food Drug Administration (PDA). International conference on harmonisation, good clinical practice consolidated guidelines. Federal Register 1997 62 25692-709. 

International Conference of Harmonisation. E6 Guideline for Good Clinical Practice, 1996. http //www.emea.eu.int/pdfs/human/ich/ 013595en.pdf, Accessed January 2005. 

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