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Review
. 2003 Jan;55(1):1-5.
doi: 10.1046/j.1365-2125.2003.01713.x.

Good clinical practice: a nuisance, a help or a necessity for clinical pharmacology?

John Sweatman  1
Affiliations
Review

Good clinical practice: a nuisance, a help or a necessity for clinical pharmacology?

John Sweatman. Br J Clin Pharmacol. 2003 Jan.

Abstract

This article reviews the impact of good clinical practice (GCP) on clinical pharmacology with particular reference to the new European Union Clinical Trial Directive. The Directive will be applied to both commercial and noncommercial studies on medicinal products for human use. The Directive requires that GCP should be used in all clinical trials except noninterventional studies. GCP is likely to follow the International Conference on Harmonization GCP guidelines in many aspects. GCP will enforce tighter guidelines on ethical aspects of a clinical study. Higher standards will be required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities including computers. Quality assurance and inspections will ensure that these standards are achieved. The additional requirements of GCP are discussed and any advantage to the study subject. The impact of the new Directive within the Research Governance Framework of the UK Department of Health is reviewed.

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References

    1. European Parliament. Directive 2001/20/EC of the European parliament and of the council of 04 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. Official Journal of the European Communities. 2001;121:34–44. - PubMed
    1. World Medical Association (WMA) Declaration of Helsinki, 52nd WMA General Assembly. Edinburgh, Scotland: 2000. Available at: http://www.wma.net/e/policy/17-c_e.html.
    1. International. Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Topic E6 Note for Guidance on Good Clinical Practice: Consolidated Guideline. London: European Agency for the Evaluation of Medicinal Products; 1996.
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