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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 3 File Tool	Form	Modified	Available
Form 2 Aggregate Accrual	Form	Modified	Available
Form 1 Accrual Updates	Form	Modified	Available
Form 1 Registration	Form	Modified	Available
Form 1 Registration	Form	Modified	Available
Form 2 Registration	Form	Modified	Available
Form 1 Registration	Form and Instruction	Modified	Available
30day 0600.pdf	Supplementary Document	Uploaded 2026-03-31	Available
30day Notice NCI.pdf	Supplementary Document	Uploaded 2026-03-23	Available
SSA CTRP_Reinstatement With Change_20260303.docx	Supporting Statement A	Uploaded 2026-03-03	Available
Attachment 11 CTRP_Strategic_Subcommittee_Report.pdf	Supplementary Document	Uploaded 2026-03-03	Available
Attachment 10 CTRP Privacy Act Letter 202508.pdf	Supplementary Document	Uploaded 2026-03-03	Available
Attachment 9 - NIH OHSR Statement of Exemption.pdf	Supplementary Document	Uploaded 2026-03-03	Available
Attachment 8 _ CTRP Consultation Outside Organizations.pdf	Supplementary Document	Uploaded 2026-03-03	Available
Attachment 7 - CTRP_Accrual_User_Guide_2026.pdf	Supplementary Document	Uploaded 2026-03-03	Available
Attachment 6 - CTRP_Registration_User_Guide_2026.pdf	Supplementary Document	Uploaded 2026-03-02	Available
Attachment 2 - CTWG-report.pdf	Supplementary Document	Uploaded 2026-03-02	Available
Attachment 1 - NCI Advisory Board.pdf	Supplementary Document	Uploaded 2026-03-02	Available
Attachment 4 - NCI CTRP PIA 05212025.pdf	Supplementary Document	Uploaded 2026-03-02	Available
Attachment 10 CTRP Privacy Act Letter 202508.pdf	Supplementary Document	Uploaded 2026-03-02	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
221670	Accrual Updates	Form	Modified	File Tool
221670	Accrual Updates	Form	Modified	Aggregate Accrual
221670	Accrual Updates	Form	Modified	Accrual Updates
221669	Trial Registration Amendment	Form	Modified	Registration
221668	Trial Registration Update	Form	Modified	Registration
221667	Initial Trial Registration	Form	Modified	Registration
221667	Initial Trial Registration	Form and Instruction	Modified	Registration

ICR Details

OMB Control No: 0925-0600	ICR Reference No: 202601-0925-001
Status: Received in OIRA	Previous ICR Reference No: 202209-0925-003
Agency/Subagency: HHS/NIH	Agency Tracking No: 19222
Title: The Clinical Trials Reporting Program (CTRP) Database (NCI)
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 04/01/2026

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	24,000	0
Time Burden (Hours)	18,000	0
Cost Burden (Dollars)	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 42 USC 410 (285a-4(b)) Name of Law: Public Health Service Act
   US Code: 42 USC 407 (285a-2(a)(2)(D)) Name of Law: Public Health Service Act
   US Code: 42 USC 410 (285a-2(a)(1)) Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 60112	12/23/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 14861	03/31/2026
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

table that charts list of burden

IC Title	Form No.	Form Name
Accrual Updates	1, 2, 3	Accrual Updates ,   Aggregate Accrual ,   File Tool
Initial Trial Registration	1, 2	Registration ,   Registration
Trial Registration Amendment	1	Registration
Trial Registration Update	1	Registration

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ICR Summary of Burden

table that charts list of burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	24,000	0	0	-3,000	0	27,000
Annual Time Burden (Hours)	18,000	0	0	0	0	18,000
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Changing Forms

Short Statement: This is a Reinstatement With Change with several notable changes listed in A.15 of the Supporting Statement A.

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Annual Cost to Federal Government: $6,412,305

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 04/01/2026

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