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
 

10.4 Responsibilities of the sponsor and monitor1

1 See also sections 5 and 6.

The sponsor is responsible for:

• Supplying the investigational and, when appropriate, comparator product(s), prepared in accordance with principles of Good Manufacturing Practice. The products should be fully characterized, properly coded, and suitably packaged in such a way as to provide protection against deterioration during transport and storage at intermediate destinations; appropriate investigational labelling should be affixed (see Section 10.2).

• Ensuring that the package of investigational product(s) is of a size suitable for the trial and adequate for the trial subjects.

• Keeping sufficient samples from each batch used in the trial as a reference for control tests and validation of data, as required in national regulations.

• Providing information about the expiry date (month/year) or retest date information in a manner understandable to all staff involved in the trial.

During the visits to the clinical trial site, the monitor should check:

• That all study products for the trial are used exclusively within the limits defined by the protocol.

• That inventory records of study products are in order and that there are sufficient supplies.

• That the expiry dates are not likely to be, or have not been, exceeded.

• That the storage conditions for study products are adequate.

• Procedures for and records of returned and/or unused study products.

 

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