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

Forms and Documents

Document Name	Status
Form 3 NCI CTRP Accrual Portal Workflow and Screen Shots Form	New
Form 2 Amendment for the Clinical Trials Reporting Program (CTRP) Database (NCI) Form	Modified
Form 1 Registration for the Clinical Trials Reporting Program (CTRP) Database (NCI) Form	Modified
Cover Memo_CTRP_2009_10_14.doc Supplementary Document	2010-01-14
Attachment_6_CTRP OHSR Exemption_4947_CY2009.pdf Supplementary Document	2010-01-14
Attachment_5_CTRP Privacy Act Memo.doc Supplementary Document	2010-01-14
Attachment_4B_CTRP Research Organizations_20090603.doc Supplementary Document	2010-01-14
Attachment_4A_CTRP NCI Advisory Boards_20090603.doc Supplementary Document	2010-01-14
Attachment_3_INSTRUCT_CTRP Registration_Site_Users_Guide.pdf Supplementary Document	2010-01-15
SSA_CTRP_2010_1_12.doc Supporting Statement A	2010-01-14

IC Document Collections

IC ID	Document Title	Status
191890	NCI CTRP Accrual Portal Workflow and Screen Shots Form	New
189519	Amendment for the Clinical Trials Reporting Program (CTRP) Database (NCI) Form	Modified
189518	Registration for the Clinical Trials Reporting Program (CTRP) Database (NCI) Form	Modified

ICR Details

OMB Control No: 0925-0600	ICR Reference No: 201001-0925-003
Status: Historical Active	Previous ICR Reference No: 200906-0925-003
Agency/Subagency: HHS/NIH	Agency Tracking No:
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: 03/01/2010
	Date Received in OIRA: 01/29/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2013	36 Months From Approved	02/28/2010
Responses	49,500	0	27,500
Time Burden (Hours)	38,500	0	33,000
Cost Burden (Dollars)	0	0	0

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Abstract: The National Cancer Institute (NCI) is developing an electronic resource, the NCI Clinical Trials Reporting Program (CTRP) Database, which is intended to serve as a single, definitive source of information about all NCI-supported clinical research, thereby enabling the NCI to execute its mission to reduce the burden of cancer and to ensure an optimal return on the nation's investment in cancer clinical research. Deployment and extension of the CTRP Database is an infrastructure development project that will be enabled by public funds expended pursuant to the American Recovery and Reinvestment Act of 2009. In addition, deployment of this resource will allow the NCI to consolidate reporting, aggregate information and reduce redundant submissions. Clinical research administrators, as designees of the clinical investigators, will electronically access the CTRP website to complete the initial trial registration. After the clinical trial has been registered, four amendments and four study subject accrual updates occur per trial annually. The previous submission took into account the initial registration and amendment activities. This current submission will include registration, amendment, as well as data related to study subject accruals.

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Authorizing Statute(s): 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
   US Code: 42 USC 410 (285a-4(b)) 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:
	74 FR 57684	11/09/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 4827	01/29/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Registration for the Clinical Trials Reporting Program (CTRP) Database (NCI)	1	CTRP Registration
Amendment for the Clinical Trials Reporting Program (CTRP) Database (NCI)	2	CTRP Amendment
NCI CTRP Accrual Portal Workflow and Screen Shots	3	CTRP Accural Updates

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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	49,500	27,500	0	22,000	0	0
Annual Time Burden (Hours)	38,500	33,000	0	5,500	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: No

Burden Reduction Due to:

Short Statement: This program change is being submitted as a revised information collection and includes the study subject accrual aspects of the information collection through the CTRP Database. This revision will result in an increase in burden hours and costs associated with this project. Deployment and extension of the CTRP Database is an infrastructure development project to be conducted pursuant to the American Recovery and Reinvestment Act.

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Annual Cost to Federal Government: $4,200,000

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Yes

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: 01/29/2010

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