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WHO Expert Committee on Selection and Use of Essential Medicines - WHO Technical Report Series, No. 850, Annex 3 (Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products) - Sixth Report
(1995; 36 pages) [French] [Spanish] Voir le document au format PDF
Table des matières
Afficher le documentINTRODUCTION
Afficher le documentGLOSSARY
Ouvrir ce répertoire et afficher son contenu1. PROVISIONS AND PREREQUISITES FOR A CLINICAL TRIAL
Afficher le document2. THE PROTOCOL
Ouvrir ce répertoire et afficher son contenu3. PROTECTION OF TRIAL SUBJECTS
Ouvrir ce répertoire et afficher son contenu4. RESPONSIBILITIES OF THE INVESTIGATOR
Ouvrir ce répertoire et afficher son contenu5. RESPONSIBILITIES OF THE SPONSOR
Ouvrir ce répertoire et afficher son contenu6. RESPONSIBILITIES OF THE MONITOR
Ouvrir ce répertoire et afficher son contenu7. MONITORING OF SAFETY
Ouvrir ce répertoire et afficher son contenu8. RECORD KEEPING AND HANDLING OF DATA
Ouvrir ce répertoire et afficher son contenu9. STATISTICS AND CALCULATIONS
Ouvrir ce répertoire et afficher son contenu10. HANDLING OF AND ACCOUNTABILITY FOR PHARMACEUTICAL PRODUCTS
Ouvrir ce répertoire et afficher son contenu11. ROLE OF THE DRUG REGULATORY AUTHORITY
Afficher le document12. QUALITY ASSURANCE FOR THE CONDUCT OF A CLINICAL TRIAL
Afficher le document13. CONSIDERATIONS FOR MULTICENTRE TRIALS
Afficher le documentREFERENCES
Afficher le documentAPPENDIX 1: World Medical Association’s Declaration of Helsinki1
Afficher le documentAPPENDIX 2: Model list of items to be contained in a clinical trial protocol
 

WHO Expert Committee on Selection and Use of Essential Medicines - WHO Technical Report Series, No. 850, Annex 3 (Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products) - Sixth Report

*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.

 

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