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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] Ver el documento en el formato PDF
Índice de contenido
Ver el documentoINTRODUCTION
Ver el documentoGLOSSARY
Abrir esta carpeta y ver su contenido1. PROVISIONS AND PREREQUISITES FOR A CLINICAL TRIAL
Ver el documento2. THE PROTOCOL
Abrir esta carpeta y ver su contenido3. PROTECTION OF TRIAL SUBJECTS
Abrir esta carpeta y ver su contenido4. RESPONSIBILITIES OF THE INVESTIGATOR
Abrir esta carpeta y ver su contenido5. RESPONSIBILITIES OF THE SPONSOR
Abrir esta carpeta y ver su contenido6. RESPONSIBILITIES OF THE MONITOR
Abrir esta carpeta y ver su contenido7. MONITORING OF SAFETY
Abrir esta carpeta y ver su contenido8. RECORD KEEPING AND HANDLING OF DATA
Abrir esta carpeta y ver su contenido9. STATISTICS AND CALCULATIONS
Abrir esta carpeta y ver su contenido10. HANDLING OF AND ACCOUNTABILITY FOR PHARMACEUTICAL PRODUCTS
Abrir esta carpeta y ver su contenido11. ROLE OF THE DRUG REGULATORY AUTHORITY
Ver el documento12. QUALITY ASSURANCE FOR THE CONDUCT OF A CLINICAL TRIAL
Ver el documento13. CONSIDERATIONS FOR MULTICENTRE TRIALS
Ver el documentoREFERENCES
Ver el documentoAPPENDIX 1: World Medical Association’s Declaration of Helsinki1
Ver el documentoAPPENDIX 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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