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
Close this folder4. RESPONSIBILITIES OF THE INVESTIGATOR
View the document4.1 Medical care of trial subjects
View the document4.2 Qualifications
View the document4.3 Selection of trial subjects
View the document4.4 Compliance with the protocol
View the document4.5 Information for subjects and informed consent
View the document4.6 The investigational product
View the document4.7 Site of the trial, facilities and staff
View the document4.8 Notification of the trial or submission to the drug regulatory authority
View the document4.9 Review by an ethics committee
View the document4.10 Serious adverse events/reactions
View the document4.11 Financing
View the document4.12 Monitoring, auditing and inspection
View the document4.13 Record-keeping and handling of data
View the document4.14 Handling of and accountability for pharmaceutical products for trial
View the document4.15 Termination of trial
View the document4.16 Final report
View the document4.17 Trials in which the investigator is the sponsor
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
 

4.7 Site of the trial, facilities and staff

Clinical trials must be carried out under conditions which ensure adequate safety for the subjects. The site selected should be appropriate to the stage of development of the product and the potential risks involved. The trial site must have adequate facilities, including laboratories, equipment and sufficient medical, paramedical, and clerical staff to support the trial and to deal with all reasonable foreseeable emergencies. All laboratory assays must be validated, and principles of Good Laboratory Practice (GLP) should be observed.

The investigator should ensure that he or she has sufficient time to conduct and complete the trial, and that other commitments or trials do not divert essential subjects, resources or facilities away from the trial in hand.

The investigator must provide adequate information to all staff involved in the trial.

The investigator must notify or obtain approval for the trial from relevant local hospital (medical, administrative) management in compliance with existing regulations.

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