- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
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.