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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 3 NCI CTRP Accrual Portal Workflow and Screen Shots	Form	Modified	Available
Form 2 Amendment for the Clinical Trials Reporting Program (CTRP) Database (NCI)	Form and Instruction	Modified	Available
Form 1 Registration for the Clinical Trials Reporting Program (CTRP) Database (NCI)	Form and Instruction	Modified	Available
Attach_11_CTRP_Strategic_Subcommittee_Report_2011-07.pdf	Supplementary Document	Uploaded 2013-04-04	Available
Attach_10_NIH Privacy Act Memo.doc	Supplementary Document	Uploaded 2013-04-04	Available
Attach_9_NIH OHSR Statement of Exemption.pdf	Supplementary Document	Uploaded 2013-04-04	Available
Attach_8_ Outside organizations.doc	Supplementary Document	Uploaded 2013-04-04	Available
Attach_4_PIA_CTRP.doc	Supplementary Document	Uploaded 2013-04-04	Available
Attach_2_CTWG-report.pdf	Supplementary Document	Uploaded 2013-04-04	Available
Attach_1_ NCI Advisory Board.doc	Supplementary Document	Uploaded 2013-04-04	Available
Attach_7_CTRP-Accrual-UsersGuide.pdf	Supplementary Document	Uploaded 2013-04-04	Available
Attach_6_CTRP-Registration-UsersGuide.pdf	Supplementary Document	Uploaded 2013-04-04	Available
SSA_CTRP_4-3-2013.doc	Supporting Statement A	Uploaded 2013-04-04	Available

IC Document Collections

Information collection document groups

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

ICR Details

OMB Control No: 0925-0600	ICR Reference No: 201304-0925-002
Status: Historical Active	Previous ICR Reference No: 201001-0925-003
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/22/2013
	Date Received in OIRA: 04/17/2013
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2016	36 Months From Approved
Responses	49,500	0	0
Time Burden (Hours)	33,000	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: The Clinical Trials Reporting Program (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.

---

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

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 7437	02/01/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 21130	04/09/2013
Did the Agency receive public comments on this ICR? No

---

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

table that charts list of burden

IC Title	Form No.	Form Name
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
NCI CTRP Accrual Portal Workflow and Screen Shots	3, 3	CTRP Accural Updates ,   CTRP Accrual Batch File Tool

---

ICR Summary of Burden

table that charts list 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	0	0	49,500	0	0
Annual Time Burden (Hours)	33,000	0	0	33,000	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: No

Burden Reduction Due to:

Short Statement: This application seeks a reinstatement with change for an additional 3 more years. Changes to the program have focused on improving system performance, reporting capability to support NCI information needs, and user interface enhancements. There are no changes to the information collected and no new data elements have been added. A decrease in the burden hours is being requested compared to the previous submission. In the previous submission, initial registration was estimated to take respondents up to 2 hours to complete. However after several years of analysis, it is apparent that the average time to complete the initial registration ranges from 45 to 60 minutes, rarely exceeding 1 hour to complete. Thus the estimated time to complete the initial registration has been decreased from 11,000 hours to 5,500 hours/year, which has decreased the total burden being requested from 38,500 to 33,000 hours/year.

---

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]? 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

---

Common Form ICR:  No

---

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: 04/17/2013

---