Good Clinical Practice: Current State of the Art for Clinical Trial Documentation

Allen ME . Good Clinical Practice (1994). In: International Pharmaceutical Product Registration: aspects of quality, safety and efficacy. Cartright AC Matthews BR eds. Ellis Horwood: New York, London, Toronto, Sydney, Tokyo, Singapore.

Guidelines on Good Clinical Research Practice; ABPI; March 1988.

Good Clinical Practice for Trials on Medicinal Products in the European Community. III/3976/88-EN Final. Published in: Pharmacol Toxicol 1990, 67, 361–372.

Note for Guidance on Good Clinical Practice. CPMP/ICH/135/95.

Explanatory Note and Comments to the ICH Harmonised Tripartite Guideline E6: Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95).

Note for Guidance on Structure and Content of Clinical Study Reports CPMP/ICH/137/95 (with Annexes I-VIII).

CPMP guidelines can be obtained from the EMEA, 7 Westbury Circus, Canary Wharf, LONDON E14 4HB or from the EMEA website: http://www.eudra.org/emea.html.