2004D-0440 - Computerized Systems Used in Clinical Trials Guidance
FDA Comment Number : EC1
Submitter : Mr. Gregory Gogates Date & Time: 10/15/2004 04:10:07
Organization : CRF Inc.
Private Industry
Category :
Issue Areas/Comments
GENERAL
GENERAL
CRF Inc provides software and services that collect electronic patient reported outcomes for clinical trials. The draft CSUCT guidance document was reviewed with consieration for our industry space. The attached following comments and markup document shows the issues seen as items requiring clarification and revision.