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

OMB 0925-0600

This is a request for a revision 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 approval of the aesthetic changes to the website and the technology that currently supports this information collection. There are no changes to the questions asked or the order in which the information is collected.

The latest form for The Clinical Trials Reporting Program (CTRP) Database (NCI) expires 2022-10-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form 6 Accrual Updates Form and Instruction
Form 5 Update Screenshots Form and Instruction
Form 4 Amendment Form and Instruction
Form 1 Initial Registration Form and Instruction
pub NCI CTRP 30-day FRN.pdf Supplementary Document
SSA CTRP - Extension 9.16.2022 v3.docx Supporting Statement A
Attachment 11 - CTRP_Strategic_Subcommittee_Report_2011-07.pdf Supplementary Document
Attachment 10 - Privacy Act Letter 2019.pdf Supplementary Document
Attach_9_NIH OHSR Statement of Exemption.pdf Supplementary Document
Attachment 8 - Outside organizations.pdf Supplementary Document
Attachment 7 - CTRP_Accrual_User_Guide.pdf Supplementary Document
Attachment 6 - CTRP_Registration_User_Guide.pdf Supplementary Document
Attachment 4 - CTRP-PIA dated 2020.pdf Supplementary Document
Attachment 2 - CTWG-report.pdf Supplementary Document
Attachment 1 - NCI Advisory Board-6-2-2022.pdf Supplementary Document
Accrual Updates Form and Instruction
Update Screenshots Form and Instruction
Amendment Form and Instruction
Initial Registration Form and Instruction

All Historical Document Collections

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 Registration

Federal Enterprise Architecture: Health - Health Care Services

Form 2	Attach 5A CTRP Registry Complete Batch Template	Fillable Fileable	Form and instruction
Form 1	NCI CTRP Registration Screenshots	Fillable Fileable	Form and instruction
Form 3	Attach 5B CTRP Registry Complete Trial Participating Sites Template	Fillable Fileable	Form and instruction

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