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
 

10.1 Supply and storage

The arrangements made by the sponsor to supply the investigator with pharmaceutical products for the trial should be described in the protocol. The manner in which study products are to be recorded, delivered, dispensed and stored should be detailed.

The principles of Good Manufacturing Practice (1) should be applied not only by the supplier of the pharmaceutical product(s), but also by any intermediaries responsible for storing the product(s) temporarily.

Records must be kept of information about the shipment, delivery, receipt, storage, return and destruction of any remaining pharmaceutical products. The investigator should not supply the investigational product to any person not targeted to receive it. Preferably a local pharmacy or the pharmacy department of the local hospital should assume responsibility for storage, delivery, return and keeping records of the investigational and, when appropriate, comparator product(s). If so, these procedures must be documented to make auditing possible.

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