Docket Management
Docket: 00D-1539 - Draft Guid: Electronic Rec'ds; Electronic Signatures, Maintenance of Electronic Rec'ds
Comment Number: EC -1

Accepted - Volume 6

Comment Record
Commentor Dr. Jules Mitchel Date/Time 2002-09-12 07:16:08
Organization Target Health Inc.
Category Company

Comments for FDA General
1. General Comments 1. This document is well written and makes its points quite clearly. 2. There are several references to the records retention period. It may be important to cross reference the predicate rule as to what is that period as related to clinical trial research data. 3. In clinical trials, all CRF data are eventually migrated into SAS. Once this is done and there is either electronic or paper documentation of the data (which is always sent to FDA in the NDA submission), the audit trail of changes to the database, as well as documentation of the electronic signatures, why must the entire data capture system be retained as opposed to the actual data? 4. From a pragmatic point of view, and perhaps to simplify the data retention system, during the application validation process, there should be adequate documentation as to the overall performance of the system.

EC -1