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
Close this folder5. RESPONSIBILITIES OF THE SPONSOR
View the document5.1 Selection of the investigator(s)
View the document5.2 Delegation of responsibilities
View the document5.3 Compliance with the protocol and procedures
View the document5.4 Product information
View the document5.5 Safety information
View the document5.6 Investigational product
View the document5.7 Trial management and handling of data
View the document5.8 Standard operating procedures
View the document5.9 Compensation for subjects and investigators
View the document5.10 Monitoring
View the document5.11 Quality assurance
View the document5.12 Study reports
View the document5.13 Handling of adverse events
View the document5.14 Termination of trial
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
 

5.3 Compliance with the protocol and procedures

The sponsor is responsible for assuring the investigator’s agreement to undertake the clinical trial as described in the protocol, and according to Good Clinical Practice, and to accept procedures for data recording (particularly in the case-report form or CRF), monitoring, audits, and inspections. The sponsor and the investigator must sign the protocol or an alternative document confirming this agreement.

Both the sponsor and the investigator should agree to any amendment to the protocol before it is implemented and this should be documented in writing.

Amendments which may affect the safety of the subjects or the conduct of the trial should be submitted in writing to the ethics committee (see Section 3.2) through the investigator or, if applicable, directly by the sponsor. The sponsor should provide justification for the amendments. If required, the amendments should be submitted to the drug regulatory authority. The amendments should not be implemented until all required approvals have been obtained, unless the delay caused by this process is likely to expose the subjects to an immediate hazard or danger.

to previous section
to next section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: November 5, 2014