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
 

8.2 Responsibilities of the sponsor and the monitor

(a) When electronic data handling or remote electronic data entry systems are employed, the sponsor must use validated, data processing programs with adequate user documentation. A predetermined set of standard operating procedures (SOP) for such systems must be available. Such systems should be designed to allow correction after loading, and the corrections made must appear in an audit file.

(b) Appropriate measures should be taken by the monitor to avoid overlooking missing data or including inconsistencies. If a computer assigns values automatically when data are missing, this should be made clear.

(c) The sponsor must ensure the greatest possible accuracy when processing data. If data are transformed during processing, the transformation must be documented and the method validated. It should always be possible to compare the data printout with the original observations and findings.

(d) The sponsor must be able to identify all data entered pertaining to each subject by means of an unambiguous code.

(e) The sponsor must maintain a list of persons authorized to make corrections, and prevent unauthorized access to the data by appropriate security systems.

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