NCI_CTRPDbase_Attachment 5

DATE: June 26, 2009

TO: John Speakman

Center for Biomedical Informatics and Information Technology

Office of the Director

National Cancer Institute

FROM: NIH Privacy Act Officer

SUBJECT: Applicability of the Privacy Act: “NCI Clinical Trials Reporting Program (CTRP) Database”

I have reviewed the NCI/CBIIT submission to OMB requesting approval to provide a real-time view of the status of NCI-funded cancer clinical trials, which will enable NCI to make informed prioritization decisions via disease-specific steering committees.

I have determined that the Privacy Act will not apply to this data collection which involves the online registration by clinical investigators of clinical trials via the NCI Clinical Trials web portal and direct connection of site systems to NCI Enterprise Services for seamless, near real-time update of the database.

Clinical investigators who conduct NIH-supported clinical research and their research administrative designees will be asked to register online and provide work related information. They will be assigned a unique identifier in order to search and view clinical trial details. The system was designed to retrieve by investigator name but the name does not link to any personally identifiable information.

If you have any questions, please contact my office at (301) 402-6201.

Karen M. Plá

Attachment

cc: V. Horovitch-Kelley, NCI OMB Project Clearance Liaison Office