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