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
 

11.1 General responsibilities

The national drug regulatory authority should ensure that the protocols for clinical trials are submitted in advance for review and are in accordance with existing national regulations. On the basis of its review of clinical trial protocols and/or reports, the regulatory authority may propose revisions or request additional data on a clinical trial or terminate a trial.

The drug regulatory authority should evaluate the adequacy of supervision of the trial by reviewing the monitor’s reports to the sponsor (see Section 6.9). In addition, the authority should be able to conduct on-site inspections of the reliability and quality of reported results.

National regulations should specify the procedures for reporting and handling cases of misconduct discovered in connection with clinical trials.

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