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
Close this folder10. HANDLING OF AND ACCOUNTABILITY FOR PHARMACEUTICAL PRODUCTS
View the document10.1 Supply and storage
View the document10.2 Investigational labelling and packaging
View the document10.3 Responsibilities of the investigator
View the document10.4 Responsibilities of the sponsor and monitor1
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
 

10. HANDLING OF AND ACCOUNTABILITY FOR PHARMACEUTICAL PRODUCTS

The sponsor is responsible for ensuring that the investigational pharmaceutical product(s) and, if applicable, comparator products supplied for the clinical trial are of appropriate quality and subject to quality assurance procedures (see Section 5.11).

If significant changes are made in the formulation of the investigational or comparator product during the course of the trial, the results of additional studies (e.g. on the stability, comparative dissolution rate or, as appropriate, comparative bioavailability) should be made available before the new formulation is used in the trial. The studies would demonstrate that the changes would not be expected to alter the pharmacokinetic profile or other clinical characteristics of the product.

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