05
Mar
2002

Ochsner Clinical Foundation – Part 11 related

0

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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