Docket Management
Docket: 01D-0489 - Draft Guidance: Clinical Trial Sponsors on the Establishment & Operation of Clinical Trial DMCs
Comment Number: EC -3

Accepted - Volume 1

Comment Record
Commentor Dr. Arthur Schneider Date/Time 2001-12-17 10:27:54
Organization University of Illinois
Category Health Professional

Comments for FDA General
Questions
1. General Comments The Guidance does not appear to deal with the question of who has access to the list of members serving on a DMC. Is it ever appropriate for a member, or all of the members, to serve anonimously? If an IRB requests information about the composition of a DMC, is it sufficient for the IRB to receive the number of members and their qualifications, but not their names?




EC -3