Audit trail
From Clinfowiki
Audit Trail- a secure, computer generated, time stamped electronic record that allows reconstruction of the course of events relating to the creation, modification, and deletion of an electronic record.[1]
Computerized Systems Used in Clinical Trials
In 1997, the FDA developed Title 21 Code of Federal Regulations (21 CFR Part 11 FDA), a uniform approach to regulating record keeping, reporting and electronic signature practices for all business function under its control. [1]
- Persons must use secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. A record is created when it is saved to durable media.
- Audit trails must be retained for a period at least as long as that required for the subject electronic records (e.g., the study data and records to which they pertain) and must be available for agency review and copying.
- Personnel who create, modify, or delete electronic records should not be able to modify the audit trails.
- Clinical investigators should retain either the original or a certified copy of audit trails.
- FDA personnel should be able to read audit trails both at the study site and at any other location where associated electronic study records are maintained.
- Audit trails should be created incrementally, in chronological order, and in a manner that does not allow new audit trail information to overwrite existing data.
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