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
Close this folder1. PROVISIONS AND PREREQUISITES FOR A CLINICAL TRIAL
View the document1.1 Justification for the trial
View the document1.2 Ethical principles
View the document1.3 Supporting data for the investigational product
View the document1.4 Investigator and site(s) of investigation
View the document1.5 Regulatory requirements
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
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
 

1.4 Investigator and site(s) of investigation

Each investigator should have appropriate expertise, qualifications and competence to undertake a proposed study. Prior to the trial, the investigator(s) and the sponsor should establish an agreement on the protocol, standard operating procedures (SOP), the monitoring, and auditing of the trial, and the allocation of trial-related responsibilities. The trial site should be adequate to enable the trial to be conducted safely and efficiently (see chapter 4.7).

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