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. RECORD KEEPING AND HANDLING OF DATA

The aim of record-keeping and handling of data is to record, store, transfer and, where necessary, convert efficiently and accurately, the information gathered on each trial subject into data that can be used in the report.

All steps involved in data management should be documented in order to allow step-by-step retrospective assessment of quality of the data and the performance of the clinical trial (the “audit paper trail” concept). Documentation is facilitated by methods such as the use of check-lists and forms giving details of action taken, dates, the individuals responsible, etc.

The allocation of responsibilities for record-keeping and handling of data should be specified in the protocol or other written agreement(s) between the sponsor and investigator(s).

A basic aspect of the integrity of data is the safeguarding of “blinding” with regard to treatment assignment. It starts with the randomization of patients into treatment groups and is maintained through all steps of data processing up to the moment when the decision to break the code is formally taken.

In the event of electronic data handling, confidentiality of the database must be secured by safety procedures such as passwords and written assurances from all staff involved. Provision must be made for the satisfactory maintenance of the database and for back-up procedures.

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