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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
 

12. QUALITY ASSURANCE FOR THE CONDUCT OF A CLINICAL TRIAL

The sponsor is responsible for implementing a system of quality assurance in order to ensure that the trial is performed and the data are generated, recorded, and reported in compliance with the protocol, Good Clinical Practice, and national regulations.

All clinical trial sites, data and documents must be available for verification. All observations and findings should be verifiable in order to ensure the credibility of data and to assure that the conclusions presented are derived correctly from the raw data. The verification processes must be specified and scientifically justified. Statistically controlled sampling may be used to verify data in a trial.

Quality control procedures must be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly.

The sponsor, investigational sites, facilities and laboratories, and all relevant data (including raw data) and documentation and reports concerning the data (including subject files) must be available for an audit and for inspection by relevant health authorities. The audit should be conducted by a nominated person(s) or organization(s) independent of those carrying out the clinical trial.

 

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