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

Forms and Documents

Document Name	Status
Form 6 Accrual Updates Form and Instruction	New
Form 5 Update Screenshots Form and Instruction	New
Form 4 Amendment Form and Instruction	New
Form 1 Initial Registration Form and Instruction	New
Form 3 NCI CTRP Accrual Portal Workflow and Screen Shots Form	Removed
Form 2 Amendment for the Clinical Trials Reporting Program (CTRP) Database (NCI) Form and Instruction	Removed
Form 1 Registration for the Clinical Trials Reporting Program (CTRP) Database (NCI) Form and Instruction	Removed
Published 30-Day FRN.pdf Supplementary Document	2016-05-27
Attach_11_CTRP_Strategic_Subcommittee_Report_2011-07.pdf Supplementary Document	2016-05-23
Attach_10_NIH Privacy Act Memo.doc Supplementary Document	2016-05-23
Attach_9_NIH OHSR Statement of Exemption.pdf Supplementary Document	2016-05-23
Attach_8_ Outside organizations.doc Supplementary Document	2016-05-23
Attach_7_CTRP-Accrual-UsersGuide.pdf Supplementary Document	2016-05-23
Attach_6_CTRP-Registration-UsersGuide.pdf Supplementary Document	2016-05-23
Attach_4_CTRP-PIA.pdf Supplementary Document	2016-05-23
Attach_2_CTWG-report.pdf Supplementary Document	2016-05-23
Attach_1_ NCI Advisory Board.doc Supplementary Document	2016-05-23
SSA CTRP Final.docx Supporting Statement A	2016-05-23

IC Document Collections

IC ID	Document Title	Status
221670	Accrual Updates Form and Instruction	New
221669	Update Screenshots Form and Instruction	New
221668	Amendment Form and Instruction	New
221667	Initial Registration Form and Instruction	New
191890	NCI CTRP Accrual Portal Workflow and Screen Shots Form	Removed
189519	Amendment for the Clinical Trials Reporting Program (CTRP) Database (NCI) Form and Instruction	Removed
189518	Registration for the Clinical Trials Reporting Program (CTRP) Database (NCI) Form and Instruction	Removed

ICR Details

OMB Control No: 0925-0600	ICR Reference No: 201605-0925-006
Status: Historical Active	Previous ICR Reference No: 201304-0925-002
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: 08/26/2016
	Date Received in OIRA: 05/31/2016
Terms of Clearance: 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	08/31/2019	36 Months From Approved	08/31/2016
Responses	27,000	0	49,500
Time Burden (Hours)	18,000	0	33,000
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:
	81 FR 12914	03/11/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 103	05/27/2016
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
Update Screenshots	5	NCI CTRP Update Screenshots
NCI CTRP Accrual Portal Workflow and Screen Shots	3, 3	CTRP Accural Updates ,   CTRP Accrual Batch File Tool
Initial Registration	1, 2, 3	NCI CTRP Registration Screenshots ,   CTRP Registry Complete Batch Template ,   CTRP Registry Complete Trial Participating Sites Template
Amendment	4	NCI CTRP Amendment Screenshots
Registration for the Clinical Trials Reporting Program (CTRP) Database (NCI)	1, 1, 1, 1	CTRP Registration Batch Upload Template ,   CTRP Registration Abbreviated Participating Sites Template ,   CTRP Registration Complete Batch Template ,   CTRP Registration Complete Participating Sites Template
Amendment for the Clinical Trials Reporting Program (CTRP) Database (NCI)	2	Screenshots of Registration, Update/Amendment, and Accrual
Accrual Updates	6, 8, 7	Accural Batch File Tool ,   NCI CTRP Accural Screenshots ,   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	49,500	0	-22,500	0	0
Annual Time Burden (Hours)	18,000	33,000	0	-15,000	0	0
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: Miscellaneous Actions

Short Statement: In the 2013 OMB submission, it was estimated there would be about 5,500 trial registrations submitted annually. This estimate was due to clinical research administrators catching up on a backlog of trials considered in scope for CTRP registration. Now that all the administrators are current with trial registration, it is apparent that the number of annual clinical trial submissions does not exceed 3,000 trials submitted annually. This amounts to a decrease of 2,500 clinical trial submissions/year. This information collection request is proposing 18,000 burden hours which is a decrease in 15,000 burden hours from the original 33,000 approved burden hours in the previous information collection request.

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Annual Cost to Federal Government: $6,300,000

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

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: 05/31/2016

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