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
Close this folder11. ROLE OF THE DRUG REGULATORY AUTHORITY
View the document11.1 General responsibilities
View the document11.2 On-site inspections
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
 

11. ROLE OF THE DRUG REGULATORY AUTHORITY

The role of governments is to provide the legal framework for clinical trials. The aim should be twofold: (i) to protect the safety and rights of the subjects participating in a trial, and (ii) to ensure that trials are adequately designed to meet scientifically sound objectives. These aims may be met by several means, including the specification of the investigator’s qualifications and requirement for review and approval of the protocol by relevant scientific and/or ethics committees.

Drug regulatory authorities should have a mandate to review protocols and, where necessary, to protect the safety of subjects, to require protocol revisions and/or termination of trials.

Regulations should allow for on-site inspections of the quality and reliability of the data obtained, with due concern for confidentiality.

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