2004N-0133 - Part 11 Public Meeting; June 11, 2004
FDA Comment Number : EC10
Submitter : Ms. Jennifer Duggan Date & Time: 05/14/2004 06:05:01
Organization : GEREQ
Academia
Category :
Issue Areas/Comments
GENERAL
GENERAL
Questions arise in the application of 21CFR11, specifically electronic signatures, with regard to web-based data capture systems and subject completed questionnaires. How do we assign electronic signatures to study participants while maintaining study participant anonymity?