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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] View the PDF document
Table of Contents
View the documentINTRODUCTION
View the documentGLOSSARY
Open this folder and view contents1. PROVISIONS AND PREREQUISITES FOR A CLINICAL TRIAL
View the document2. THE PROTOCOL
Open this folder and view contents3. PROTECTION OF TRIAL SUBJECTS
Open this folder and view contents4. RESPONSIBILITIES OF THE INVESTIGATOR
Open this folder and view contents5. RESPONSIBILITIES OF THE SPONSOR
Open this folder and view contents6. RESPONSIBILITIES OF THE MONITOR
Open this folder and view contents7. MONITORING OF SAFETY
Open this folder and view contents8. RECORD KEEPING AND HANDLING OF DATA
Open this folder and view contents9. STATISTICS AND CALCULATIONS
Open this folder and view contents10. HANDLING OF AND ACCOUNTABILITY FOR PHARMACEUTICAL PRODUCTS
Open this folder and view contents11. ROLE OF THE DRUG REGULATORY AUTHORITY
View the document12. QUALITY ASSURANCE FOR THE CONDUCT OF A CLINICAL TRIAL
View the document13. CONSIDERATIONS FOR MULTICENTRE TRIALS
View the documentREFERENCES
View the documentAPPENDIX 1: World Medical Association’s Declaration of Helsinki1
View the documentAPPENDIX 2: Model list of items to be contained in a clinical trial protocol
 

INTRODUCTION

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.

 

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