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Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products. WHO Technical Report Series, No. 850, Annex 3 - WHO Expert Committee on Selection and Use of Essential Medicines, Sixth Report, 1993
(1995; 36 pages) [French] [Spanish] Ver el documento en el formato PDF
Resumen
The purpose of these WHO Guidelines for Good Clinical Practice (GCP) for trials on pharmaceutical products is to set globally applicable standards for the conduct of such biomedical research on human subjects. They are based on provisions already promulgated in a number of highly developed countries including Australia, Canada, European Community countries, Japan, Nordic Countries (Denmark, Finland, Iceland, Norway and Sweden) and the United States. These guidelines inevitably vary somewhat in content and emphasis, but all are consonant with regards to the prerequisites to be satisfied and the principles to be applied as a basis for assuring the ethical and scientific integrity of clinical trials. Indeed, they have provided a formal basis for mutual recognition of clinical data generated within the interested countries. Every care has been taken, in developing the WHO Guidelines as a practicable administrative tool for use by WHO’s Member States, to assure their compatibility with existing national and other provisions. It is hoped, on the basis of further consultation, to seek formal acceptance of the Guidelines by Member States as a contribution to harmonization of national standards and to facilitating movement of pharmaceutical products internationally. No question arises, however, of challenging or replacing existing national regulations or requirements. The objective is to provide a complementary standard that can be applied worldwide. In countries where national regulations or requirements do not exist or require supplementation, relevant government officials may designate or adopt, in part or in whole, these Guidelines as the basis on which clinical trials will be conducted. The Guidelines are addressed not only to investigators, but also to ethics review committees, pharmaceutical manufacturers and other sponsors of research and drug regulatory authorities. By providing a basis both for the scientific and ethical integrity of research involving human subjects and for generating valid observations and sound documentation of the findings, these Guidelines not only serve the interests of the parties actively involved in the research process, but protect the rights and safety of subjects, including patients, and ensure that the investigations are directed to the advancement of public health objectives. The Guidelines are intended specifically to be applied during all stages of drug development both prior to and subsequent to product registration and marketing, but they are also applicable, in whole or in part, to biomedical research in general. They should also provide a resource for editors to determine the acceptability of reported research for publication and, specifically, of any study that could influence the use or the terms of registration of a pharmaceutical product. Not least, they provide an educational tool that should become familiar to everyone engaged in biomedical research and, in particular, to every newly-trained doctor.
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
 

Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products. WHO Technical Report Series, No. 850, Annex 3 - WHO Expert Committee on Selection and Use of Essential Medicines, Sixth Report, 1993

*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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