OMB control number

The Clinical Trials Reporting Program (CTRP) Database (NCI)

OMB 0925-0600 · HHS/NIH.

OMB 0925-0600

This is a request for OMB to approve a Reinstatement With Change of the “The Clinical Trials Reporting Program (CTRP) Database” for an additional three years. CTRP is an electronic resource that serves as a single, definitive source of information about all NCI-supported clinical research. This resource allows the NCI to consolidate reporting, aggregate information, and reduce redundant submissions. Information is submitted by clinical research administrators as designees of clinical investigators who conduct NCI-supported clinical research. The designees can electronically access the CTRP website to complete the initial trial registration for each protocol. Subsequent to registration, up to four amendments and four study subject accrual updates occur per protocol annually. This request is for a Reinstatement With Change of information collection.

The latest form for The Clinical Trials Reporting Program (CTRP) Database (NCI) expires 2029-05-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form 3 File Tool Form
Form 2 Aggregate Accrual Form
Form 1 Accrual Updates Form
Form 1 Registration Form
Form 1 Registration Form
Form 2 Registration Form
Form 1 Registration Form and Instruction
30day 0600.pdf Supplementary Document
30day Notice NCI.pdf Supplementary Document
SSA CTRP_Reinstatement With Change_20260303.docx Supporting Statement A
Attachment 11 CTRP_Strategic_Subcommittee_Report.pdf Supplementary Document
Attachment 10 CTRP Privacy Act Letter 202508.pdf Supplementary Document
Attachment 9 - NIH OHSR Statement of Exemption.pdf Supplementary Document
Attachment 8 _ CTRP Consultation Outside Organizations.pdf Supplementary Document
Attachment 7 - CTRP_Accrual_User_Guide_2026.pdf Supplementary Document
Attachment 6 - CTRP_Registration_User_Guide_2026.pdf Supplementary Document
Attachment 2 - CTWG-report.pdf Supplementary Document
Attachment 1 - NCI Advisory Board.pdf Supplementary Document
Attachment 4 - NCI CTRP PIA 05212025.pdf Supplementary Document
Attachment 10 CTRP Privacy Act Letter 202508.pdf Supplementary Document
Accrual Updates Form
Accrual Updates Form
Accrual Updates Form
Trial Registration Amendment Form
Trial Registration Update Form
Initial Trial Registration Form
Initial Trial Registration Form and Instruction

All Historical Document Collections

202601-0925-001	Reinstatement with change of a previously approved collection	2026-04-01
202209-0925-003 Approved without change	Extension without change of a currently approved collection	2022-09-19
201908-0925-008 Approved without change	Revision of a currently approved collection	2019-08-28
201605-0925-006 Approved without change	Revision of a currently approved collection	2016-05-31
201304-0925-002 Approved without change	Reinstatement with change of a previously approved collection	2013-04-17
201001-0925-003 Approved without change	Revision of a currently approved collection	2010-01-29
200906-0925-003 Approved with change	New collection (Request for a new OMB Control Number)	2009-06-11

OMB Details

Initial Trial Registration

Federal Enterprise Architecture: Health - Health Care Services

Form 1	Registration	Fillable Fileable	Form and instruction
Form 2	Registration	Fillable Fileable	Form

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.