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

Forms and Documents

Document Name	Status
Form 6 Accrual Updates Form and Instruction	Modified
Form 5 Update Screenshots Form and Instruction	Modified
Form 4 Amendment Form and Instruction	Modified
Form 1 Initial Registration Form and Instruction	Modified
SSA CTRP 2019 - Revision 8.27.19.docx Supporting Statement A	2019-08-28
CTRP pub 30day 2019-18202.pdf Supplementary Document	2019-08-28
Attach_11_CTRP_Strategic_Subcommittee_Report_2011-07.pdf Supplementary Document	2019-08-28
Attach_10_Privacy Act Letter 2019.pdf Supplementary Document	2019-08-28
Attach_9_NIH OHSR Statement of Exemption.pdf Supplementary Document	2019-08-28
Attach_8_ Outside organizations.pdf Supplementary Document	2019-08-28
Attach_7_CTRP_Accrual_User_Guide.pdf Supplementary Document	2019-08-28
Attach_6_CTRP_Registration_User_Guide.pdf Supplementary Document	2019-08-28
Attach_4_CTRP-PIA.docx Supplementary Document	2019-08-28
Attach_2_CTWG-report.pdf Supplementary Document	2019-08-28
Attach_1_ NCI Advisory Board.pdf Supplementary Document	2019-08-28

IC Document Collections

IC ID	Document Title	Status
221670	Accrual Updates Form and Instruction	Modified
221669	Update Screenshots Form and Instruction	Modified
221668	Amendment Form and Instruction	Modified
221667	Initial Registration Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0600	ICR Reference No: 201908-0925-008
Status: Active	Previous ICR Reference No: 201605-0925-006
Agency/Subagency: HHS/NIH	Agency Tracking No: 19222
Title: The Clinical Trials Reporting Program (CTRP) Database (NCI)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/10/2019
	Date Received in OIRA: 08/28/2019
Terms of Clearance: Previous terms continue: The agency is required to display the OMB Control Number and inform respondents of its legal significance in accordance with 5 CFR 1320.5(b).

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2022	36 Months From Approved	10/31/2019
Responses	27,000	0	27,000
Time Burden (Hours)	18,000	0	18,000
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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

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:
	84 FR 25550	06/03/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 44318	08/23/2019
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Initial Registration	2, 3, 1	NCI CTRP Registration Screenshots ,   Attach 5A CTRP Registry Complete Batch Template ,   Attach 5B CTRP Registry Complete Trial Participating Sites Template
Update Screenshots	5	Attach 3b NCI CTRP Update Screenshots
Amendment	4	Attach 3c NCI CTRP Amendment Screenshots
Accrual Updates	6, 8, 7	Attach 5c Accural Batch File Tool ,   Attach 3d NCI CTRP Accural Screenshots ,   Attach 3e NCI CTRP Aggregate Screenshot

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ICR Summary of Burden

	Total Approved	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	27,000	27,000	0	0	0	0
Annual Time Burden (Hours)	18,000	18,000	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $11,179,021

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? Uncollected

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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: 08/28/2019

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