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
Close this folder6. RESPONSIBILITIES OF THE MONITOR
View the document6.1 Qualifications
View the document6.2 Assessment of the trial site
View the document6.3 Staff education and compliance
View the document6.4 Data management
View the document6.5 Case-report forms
View the document6.6 Investigational product
View the document6.7 Communication
View the document6.8 Notification of the trial or submission to the drug regulatory authority
View the document6.9 Reports
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
 

6. RESPONSIBILITIES OF THE MONITOR

The monitor is the principal communication link between the sponsor and the investigator and is appointed by the sponsor. The number of monitors needed to ensure adequate monitoring of the clinical trial will depend on its complexity and the types of centres involved.

The main responsibility of the monitor is to oversee progress of the trial and to ensure that the study is conducted and data are handled in accordance with the protocol, Good Clinical Practice, and applicable ethical and regulatory requirements. The monitor is responsible for controlling adherence to the protocol, ensuring that data are correctly and completely recorded and reported, and confirming that informed consent is being obtained and recorded for all subjects prior to their participation in the trial. Any unwarranted deviation from the protocol or any transgression of the principles embodied in Good Clinical Practice should be reported promptly to the sponsor and the relevant ethics committee(s).

The monitor should follow a predetermined written set of standard operating procedures (SOP). A written record should be kept of all visits, telephone calls and letters to the investigator.

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