Guidelines for good clinical practice (GCP) for trials on pharmaceutical products (WHO Technical Report Series, No. 850, 1995, Annex 3) (WHO, 1995, 36 p.): (introductory text...)

Guidelines for good clinical practice (GCP) for trials on pharmaceutical products (WHO Technical Report Series, No. 850, 1995, Annex 3) (WHO, 1995, 36 p.)

		*(introductory text...)*
		INTRODUCTION
		GLOSSARY
		1. PROVISIONS AND PREREQUISITES FOR A CLINICAL TRIAL
		2. THE PROTOCOL
		3. PROTECTION OF TRIAL SUBJECTS
		4. RESPONSIBILITIES OF THE INVESTIGATOR
		5. RESPONSIBILITIES OF THE SPONSOR
		6. RESPONSIBILITIES OF THE MONITOR
		7. MONITORING OF SAFETY
		8. RECORD KEEPING AND HANDLING OF DATA
		9. STATISTICS AND CALCULATIONS
		10. HANDLING OF AND ACCOUNTABILITY FOR PHARMACEUTICAL PRODUCTS
		11. ROLE OF THE DRUG REGULATORY AUTHORITY
		12. QUALITY ASSURANCE FOR THE CONDUCT OF A CLINICAL TRIAL
		13. CONSIDERATIONS FOR MULTICENTRE TRIALS
		REFERENCES
		APPENDIX 1: World Medical Association’s Declaration of Helsinki1
		APPENDIX 2: Model list of items to be contained in a clinical trial protocol

(introductory text...)

*This text was developed in consultation with national drug regulatory authorities within WHO’s Member States. It was also discussed during two informal consultations convened by the Division of Drug Management and Policies, WHO, Geneva, from 26 to 27 June 1991 and 29 June to 3 July 1992. The participants were: Ms M. Cone, International Federation of Pharmaceutical Manufacturers Associations (IFPMA), Geneva, Switzerland; Professor P. Dayer, International Union of Pharmacology (IUPHAR), Brussels, Belgium; Professor I. Darmansjah, University of Jakarta, akarta, Indonesia; Dr J.F. Dunne, Director, Division of Drug Management and Policies, WHO, Geneva, Switzerland (Joint Secretary); Dr Y. Hirayama, New Drugs Division, Ministry of Health and Welfare, Tokyo, Japan; Professor E. Hvidberg, University Hospital, Copenhagen, Denmark (Chairman); Dr J. Idänpään-Heikkilä, Associate Director, Division of Drug Management and Policies, WHO, Geneva, Switzerland (Joint Secretary); Mr R. Laderman, Center for Drug Evaluation and Research, Food and Drug Administration, Bethesda, MD, USA; Professor V.H. Lepakhin, Russian State Center for Drug Expertise, Moscow, Russian Federation; Dr P. Maurice, Ciba-Geigy, Basel, Switzerland; Professor J.O.M. Pobee, School of Medicine, Lusaka, Zambia; Mr M. Tsukano, New Drugs Division, Ministry of Health and Welfare, Tokyo, Japan; Dr S. Westman-Naeser, Medical Products Agency, Uppsala, Sweden; Professor A. Zanini, Institute of Biomedical Science, São Paulo, Brazil; Professor Zhu Jun-Ren, Shanghai Medical University, Shanghai, China.