Docket Management
Docket: 01N-0496 - Patient Profile Viewer; Notice of Piloto Project
Comment Number: EC -5

Accepted - Volume 1

Comment Record
Commentor Dr. Frederick Wood Date/Time 2002-01-09 13:46:26
Organization Procter & Gamble Pharmaceuticals
Category Company

Comments for FDA General
Questions
1. General Comments This is a request from Procter & Gamble Pharmaceuticals (P&GP) to participate in the Patient Profile Viewer Pilot Project. P&GP has been involved with the CDISC SDS effort since its inception. As a result, P&GP is very familiar with the standards recommended by CDISC. We have experience in submitting CRT datasets as well. P&GP is considering a joint effort with a CRO if selected to participate.




EC -5