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References

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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. Official Journal of European Communities. 2001; 121: 4344.
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    Horowitz AM. FDA audits of clinical studies. Appl Clin Trials, 1992; 1(5): 2430.
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    Wilsher CR. QUASAR. J Br Assoc Res Qual Assur 2000; 72: 2829.
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    Hepworth-Jones B. FDA regulatory inspections in the UK. CRFocus 2001; 12(1): 4546.
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    International Conference Harmonisation Harmonised Tripartite Guidelines for Good Clinical Practice. CPMP/ICH/135/95, 1996.
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    Woollen SW. The facts about source documents. DIA Annual Meeting, 29 June 1999. http://www.fda.gov/cder/present/dia-699/wollen-dia99/sld001.htm.