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
Close this folder8. RECORD KEEPING AND HANDLING OF DATA
View the document8.1 Responsibilities of the investigator
View the document8.2 Responsibilities of the sponsor and the monitor
View the document8.3 Archiving 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
 

8.3 Archiving of data

As required by national regulations, the investigator must arrange for the retention of the subject identification codes for a sufficient period of time to permit any medical follow-up which may be warranted, including follow-up for delayed toxic reactions. It must be possible to identify each trial subject by name against subject and product container identification codes, treatment assignment, and the CRFs. Subject files and other supporting data must be kept for a period of time required by local regulations. The sponsor or supplier of the product must make appropriate arrangements for the retention of all other essential documentation pertaining to the clinical trial in a form which can be retrieved for future reference. Archived data may be kept on microfiche or electronic or optical record (e.g. compact disc), provided that a hard copy can be made available on request.

The protocol, documentation, approvals and all other essential documents related to the trial, including certificates that satisfactory audit and inspection procedures have been carried out, must be retained by the sponsor. Data on adverse events must always be included.

All data and documents should be made available if requested by relevant authorities.

 

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