Company: Ochsner Clinical Foundation
Date: 03/05/2002
Product: Investigational device

The manual does not adequately describe how the CIC support staff prepares and maintains records of all IRB activities, including meeting minutes, records and reports associated with investigations, and archiving. The manual does not describe how data and information are gathered, stored, and analyzed to prevent research misconduct. Also, the manual does not describe how electronically stored data and information are safeguarded and maintained.

Issuer: Center for Devices and Radiological Health (CDRH)

SoftwareCPR keywords: 21 CFR Part 11, electronic record