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
Open this folder and view contents10. HANDLING OF AND ACCOUNTABILITY FOR PHARMACEUTICAL PRODUCTS
Close this folder11. ROLE OF THE DRUG REGULATORY AUTHORITY
View the document11.1 General responsibilities
View the document11.2 On-site inspections
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
 

11.2 On-site inspections

As permitted by national regulations, the drug regulatory authority may carry out on-site inspections of the clinical trial site. Such inspections may be carried out routinely, randomly and/or for specific reasons, and should consist of a comparison of the procedures and practices of the investigator with those set out in the protocol and reports submitted to the drug regulatory authority by the investigator or the sponsor.

The inspection should determine whether the investigator has custody of the required records or, if not, who has assumed this responsibility. The data archives should be tested for ease of retrieval.

Inspections may include data audit. The drug regulatory authority should have easy access to all patient files and raw data used for and generated during the trial.

 

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