30-Day Public Comment Period: Clinical Trials Reporting Program (CTRP) Database Data Collection – NCI/NIH
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The National Cancer Institute (NCI), a division of the National Institutes of Health (NIH), has announced a 30-day public comment period under the Paperwork Reduction Act of 1995 regarding its proposed data collection activities for the Clinical Trials Reporting Program (CTRP) Database. The CTRP Database is a system used by NCI to collect, manage, and report information on clinical trials conducted or funded by the NCI. It captures trial registration details, participant data, and outcomes to support cancer research oversight and transparency. As required by the Paperwork Reduction Act, the NIH is soliciting public feedback before submitting this data collection proposal to the Office of Management and Budget (OMB) for formal review and approval. The public has 30 days from the date of this notice (March 27, 2026) to submit comments. This is an administrative procedural notice rather than a substantive regulatory change. Its primary impact is on clinical research organizations, academic medical centers, and pharmaceutical entities that submit trial data to NCI, as any approved changes to the CTRP data collection requirements could affect their reporting obligations.
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Key Changes
- NCI is proposing updates or continuation of data collection activities under the CTRP Database — exact changes subject to OMB review
- 30-day public comment window opens March 27, 2026; comments must be submitted within this period to be considered
- Following the comment period, NCI will submit the data collection proposal to OMB for formal approval
+ 2 more changes with Pro
Obligations
What this law requires
Submit comments on the proposed CTRP Database data collection activities to NCI/NIH within 30 days of March 27, 2026 (by April 26, 2026) if electing to participate in the public comment period
Comply with any changes to CTRP data collection requirements that result from OMB approval of NCI's revised data collection proposal
Submit trial registration details, participant data, and outcomes information to the CTRP Database as required by NCI
NCI must solicit and consider public feedback through a 30-day comment period before submitting the data collection proposal to OMB for formal review and approval