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