Docket Management
Docket: 01D-0489 - Draft Guidance: Clinical Trial Sponsors on the Establishment & Operation of Clinical Trial DMCs
Comment Number: EC -8

Accepted - Volume 1

Comment Record
Commentor Mrs. Amy Pinette Date/Time 2002-02-14 14:01:02
Organization SCIREX Corporation
Category Company

Comments for FDA General
Questions
1. General Comments Comment #1: There is language in the guidelines indicating that DMC members should not have a financial interest in the outcome of the trial. I'm suggesting then that they should provide Financial Disclosure like those individuals noted on the FDA Form 1572 must provide prior to and during participation in an investigational trial. Comment #2: It may be helpful to outline options for how a recommendation might be determined by a DMC (i.e. vote, consensus, is a unanimous decision necessary, etc.)and the reasons why and when one option or another might be best utilized.




EC -8