Docket Management
Docket: 01N-0496 - Patient Profile Viewer; Notice of Piloto Project
Comment Number: EC -2

Accepted - Volume 1

Comment Record
Commentor Ms. Christine Tolk Date/Time 2001-12-20 15:02:13
Organization Bayer Corporation
Category Company

Comments for FDA General
Questions
1. General Comments Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm. 1061 Rockville, MC 20852 Docket No. 01N-0496 December 20, 2001 To whom it may concern: This letter is to request participation by Christine Tolk, Bayer Corporation, Global Biometry to participate in the Patient Profiler Pilot Project, Docket No. 01N-0496. I have been a member of the SDS group of CDISC for the past two years. Bayer is willing to provide my time to work with the agency to test the patient profile viewer (PPV) with standard data sets. The data set that Bayer would provide will contain live data where the treatment groups have been artificially modified. I look forward to hearing from you in the near future. Sincerely, Christine Tolk Global Medical Standards Manager Global Biometry Bayer Corporation 400 Morgan Lane West Haven, CT 06516-4175 Phone: 203-812-2067 Email: christine.tolk.b@bayer.com




EC -2