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
 

10.3 Responsibilities of the investigator

The investigator is responsible for ensuring:

• Proper and safe handling of the investigational and, when appropriate, comparator products during and after the clinical trial, preferably in cooperation with a pharmacy (see Section 10.1);

• That the investigational product is used only in accordance with the protocol, which implies use only for subjects included in the trial and by designated staff responsible to the investigator, and that this use is documented in such a way as to ensure appropriate dosage;

• That the dosage and instructions for use are correct and that every subject involved understands them properly;

• That unused investigational and, when appropriate, comparator products are returned in accordance with the protocol to the pharmacy or sponsor or destroyed, and that proper records of these activities are kept.

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