Cancer Trials Support Unit (CTSU) Public Use Forms and Customer Satisfaction Surveys (NCI)

Forms and Documents

Document Name	Status
Form 27 Attach 8 - Low Accruing Clinical Trial Survey Form and Instruction	New
Form 26 Attach 7 - Prospective Clinical Trial Survey Form and Instruction	New
Form 25 Attach 6 - Concept Clinical Trial Survey Form and Instruction	New
Form 24 Attach 5 - Protocol and Information Office (PIO) External Customer Satisfaction Form and Instruction	New
Form 5 Attach 1E_CTSU Site Addition Form Form and Instruction	Modified
Form 14 Attach 1N - CTSU Generic Data Transmittal Form Form and Instruction	Modified
Form 23 Attach 4 - CTSU Oncology Patient Enrollment Network (OPEN) Survey Form and Instruction	Modified
Form 22 Attach 3 - CTSU Helpdesk Customer Satisfaction Survey Form and Instruction	Modified
Form 23 Attach 2 - CTSU Web Site Customer Satisfaction Survey Form and Instruction	Modified
Form 20 Attach 1T - CTSU Supply Request Form Form and Instruction	Modified
Form 19 Attach 1S - CTSU Request for Clinical Brochure Form and Instruction	Modified
Form 18 Attach 1R - CTSU System Account Request Form Form and Instruction	Modified
Form 17 Attach 1Q - CTSU Transfer Form Form and Instruction	Modified
Form 16 Attach 1P - CTSU P2C Enrollment Transmittal Form Form and Instruction	Modified
Form 15 Attach 1o - CTSU Patient Enrollment Transmittal Form Form and Instruction	Modified
Form 26 Attach 1Z - USMCI 8214/Z6091 Crossover Request/Checklist Transmittal Form Form and Instruction	Removed
Form 25 Attach 1Y - USMCI 8214/Z6091: CTSU Data Transmittal Form and Instruction	Removed
Form 24 Attach 1X- Site Initiated Data Update Form, Protocol 8121 Form and Instruction	Removed
Form 23 Attach 1W - 8121 CTSU Data Transmittal Form Form and Instruction	Removed
Form 13 Attach 1M - MC0845(8233) CTSU Data Transmittal Form and Instruction	Modified
Form 21 Attach 1U - Site Initiated Data Update Form, protocol 7868 Form and Instruction	Removed
Form 20 Attach 1T - CTSU 7868 Data Transmittal Form Form and Instruction	Removed
Form 12 Attach 1L - RTOG 0834 CTSU Data Transmittal Form Form and Instruction	Modified
Form 18 Attach 1R - Z6051 CTSU Data Transmittal Form Form and Instruction	Removed
Form 17 Attach 1Q - Z1041 CTSU Data Transmittal Form Form and Instruction	Removed
Form 16 Attach 1P - Z1031 CTSU Data Transmittal Form Form and Instruction	Removed
Form 15 Attach 1O - Z4032 CTSU Data Transmittal Form Form and Instruction	Removed
Form 14 Attach 1N - Unsolicited Data Modification Form (UDM), Protocol:TAILORx/PACCT1 Form and Instruction	Removed
Form 11 Attach 1K - Data Clarification Form Form and Instruction	Modified
Form 12 Attach 1L - TAILORX/PACCT 1 CTSU Data Transmittal Form Form and Instruction	Removed
Form 11 Attach 1K - Site Initiated Data Update Form (DUF), Protocol: NCCTG N0147 Form and Instruction	Removed
Form 10 Attach 1J - N0147 CTSU Data Transmittal Form Form and Instruction	Removed
Form 10 Attach 1J - Site Initiated Data Update Form (generic) Form and Instruction	Modified
Form 9 Attach 1I - CTSU IBCSG Transfer of Investigational Agent Form Form and Instruction	Modified
Form 8 Attach 1H - CTSU IBCSG Drug Accountability Form Form and Instruction	Modified
Form 7 Attach 1G - CTSU Radiation Therapy Facilities Inventory Form Form and Instruction	Modified
Form 6 Attach 1F - CTSU Roster Update Form Form and Instruction	Modified
Form 4 Attach 1D - Optional Form 1 - Withdrawal from Protocol Participation Form Form and Instruction	Modified
Form 3 Attach 1C- CTSU Acknowledgement Form Form and Instruction	Modified
Form 2 Attach 1B - CTSU IRB Certification Form Form and Instruction	Modified
Form 1 Attach 1A - CTSU IRB/Regulatory Approval Transmittal Form Form and Instruction	Modified
SSB_CTSU_10-25-2013.docx Supporting Statement B	2013-10-30
attachment_11_privacy act memo.pdf Supplementary Document	2013-10-30
attachment_10_irb and OHSR determination.pdf Supplementary Document	2013-10-30
attachment_9_PIA.pdf Supplementary Document	2013-10-30
Cover Memo_10-25-2013.doc Supplementary Document	2013-10-30
SSA_CTSU_11-19-2013.docx Supporting Statement A	2013-11-19

IC Document Collections

IC ID	Document Title	Status
209614	Attach 8 - Low Accruing Clinical Trial Survey Form and Instruction	New
209613	Attach 7 - Prospective Clinical Trial Survey Form and Instruction	New
209612	Attach 6 - Concept Clinical Trial Survey Form and Instruction	New
209611	Attach 5 - Protocol and Information Office (PIO) External Customer Satisfaction Form and Instruction	New
199005	Attach 1E_CTSU Site Addition Form Form and Instruction	Modified
195188	Attach 1N - CTSU Generic Data Transmittal Form Form and Instruction	Modified
195187	Attach 4 - CTSU Oncology Patient Enrollment Network (OPEN) Survey Form and Instruction	Modified
195186	Attach 3 - CTSU Helpdesk Customer Satisfaction Survey Form and Instruction	Modified
195185	Attach 2 - CTSU Web Site Customer Satisfaction Survey Form and Instruction	Modified
195184	Attach 1T - CTSU Supply Request Form Form and Instruction	Modified
195183	Attach 1S - CTSU Request for Clinical Brochure Form and Instruction	Modified
195182	Attach 1R - CTSU System Account Request Form Form and Instruction	Modified
195181	Attach 1Q - CTSU Transfer Form Form and Instruction	Modified
195180	Attach 1P - CTSU P2C Enrollment Transmittal Form Form and Instruction	Modified
195179	Attach 1o - CTSU Patient Enrollment Transmittal Form Form and Instruction	Modified
195178	Attach 1Z - USMCI 8214/Z6091 Crossover Request/Checklist Transmittal Form Form and Instruction	Removed
195177	Attach 1Y - USMCI 8214/Z6091: CTSU Data Transmittal Form and Instruction	Removed
195176	Attach 1X- Site Initiated Data Update Form, Protocol 8121 Form and Instruction	Removed
195175	Attach 1W - 8121 CTSU Data Transmittal Form Form and Instruction	Removed
195174	Attach 1M - MC0845(8233) CTSU Data Transmittal Form and Instruction	Modified
195173	Attach 1U - Site Initiated Data Update Form, protocol 7868 Form and Instruction	Removed
195172	Attach 1T - CTSU 7868 Data Transmittal Form Form and Instruction	Removed
195171	Attach 1L - RTOG 0834 CTSU Data Transmittal Form Form and Instruction	Modified
195170	Attach 1R - Z6051 CTSU Data Transmittal Form Form and Instruction	Removed
195169	Attach 1Q - Z1041 CTSU Data Transmittal Form Form and Instruction	Removed
195168	Attach 1P - Z1031 CTSU Data Transmittal Form Form and Instruction	Removed
195167	Attach 1O - Z4032 CTSU Data Transmittal Form Form and Instruction	Removed
195166	Attach 1N - Unsolicited Data Modification Form (UDM), Protocol:TAILORx/PACCT1 Form and Instruction	Removed
195165	Attach 1K - Data Clarification Form Form and Instruction	Modified
195164	Attach 1L - TAILORX/PACCT 1 CTSU Data Transmittal Form Form and Instruction	Removed
195163	Attach 1K - Site Initiated Data Update Form (DUF), Protocol: NCCTG N0147 Form and Instruction	Removed
195162	Attach 1J - N0147 CTSU Data Transmittal Form Form and Instruction	Removed
195161	Attach 1J - Site Initiated Data Update Form (generic) Form and Instruction	Modified
195160	Attach 1I - CTSU IBCSG Transfer of Investigational Agent Form Form and Instruction	Modified
195159	Attach 1H - CTSU IBCSG Drug Accountability Form Form and Instruction	Modified
195158	Attach 1G - CTSU Radiation Therapy Facilities Inventory Form Form and Instruction	Modified
195157	Attach 1F - CTSU Roster Update Form Form and Instruction	Modified
195156	Attach 1D - Optional Form 1 - Withdrawal from Protocol Participation Form Form and Instruction	Modified
195155	Attach 1C- CTSU Acknowledgement Form Form and Instruction	Modified
195154	Attach 1B - CTSU IRB Certification Form Form and Instruction	Modified
195153	Attach 1A - CTSU IRB/Regulatory Approval Transmittal Form Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0624	ICR Reference No: 201312-0925-003
Status: Historical Active	Previous ICR Reference No: 201211-0925-011
Agency/Subagency: HHS/NIH	Agency Tracking No: 20796
Title: Cancer Trials Support Unit (CTSU) Public Use Forms and Customer Satisfaction Surveys (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: 01/03/2014
	Date Received in OIRA: 12/06/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2017	36 Months From Approved	01/31/2014
Responses	237,560	0	289,918
Time Burden (Hours)	25,204	0	34,827
Cost Burden (Dollars)	0	0	0

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Abstract: The Cancer Therapy Evaluation Program (CTEP) establishes and supports programs to facilitate the participation of qualified investigators on CTEP-supported studies, and to institute programs that minimize redundancy among grant and contract holders, thereby reducing overall cost of maintaining a robust treatment trials program. Currently guided by the efforts of the Clinical Trials Working Group (CTWG) and the Institute of Medicine (IOM) recommendations to revitalize the Cooperative Group program, CTEP has funded the Cancer Trials Support Unit (CTSU). The CTSU collects standardized forms to process site regulatory information, changes to membership, patient enrollment data, and routing information for case report forms. In addition, CTSU collects seven surveys used for customer satisfaction or related to clinical trials. The customer satisfaction surveys assess different areas of service delivery at CTSU including: the CTSU Help Desk, the CTSU web site, the Protocol and Information Office (PIO), and the Oncology Patient Enrollment Network (OPEN). User satisfaction surveys are compiled as part of the project quality assurance activities and are used to direct improvements to processes and technology. Additionally, there are three surveys collect information about health professional's interests in clinical trial, potential issues with opening and accruing to a clinical trial and reasons for low accrual.

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Authorizing Statute(s): US Code: 42 USC 413(285a-2) 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:
	78 FR 53763	08/30/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 69428	11/19/2013
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 27

IC Title	Form No.	Form Name
Attach 1Q - Z1041 CTSU Data Transmittal Form	17	Attach 1Q - Z1041 CTSU Data Transmittal Form
Attach 1R - Z6051 CTSU Data Transmittal Form	18	Attach 1R - Z6051 CTSU Data Transmittal Form
Attach 1T - CTSU 7868 Data Transmittal Form	20	Attach 1T - CTSU 7868 Data Transmittal Form
Attach 1U - Site Initiated Data Update Form, protocol 7868	21	Attach 1U - Site Initiated Data Update Form, protocol 7868
Attach 1L - RTOG 0834 CTSU Data Transmittal Form	12	RTOG 0834 CTSU Data Transmittal Form
Attach 1M - MC0845(8233) CTSU Data Transmittal	13	MC0845 (8233) CTSU Data Transmittal Form
Attach 1o - CTSU Patient Enrollment Transmittal Form	15	CTSU Patient Enrollment Transmittal Form
Attach 1P - CTSU P2C Enrollment Transmittal Form	16	CTSU P2C Enrollment Transmittal Form
Attach 1Q - CTSU Transfer Form	17	CTSU Transfer Form
Attach 1R - CTSU System Account Request Form	18	CTSU System Account Request Form
Attach 1S - CTSU Request for Clinical Brochure	19	CTSU Request for Clinical Brochure
Attach 1T - CTSU Supply Request Form	20	CTSU Supply Request Form
Attach 1E_CTSU Site Addition Form	5	Site Addition Form
Attach 5 - Protocol and Information Office (PIO) External Customer Satisfaction	24	Protocol and Information Office (PIO) External Customer Satisfaction
Attach 6 - Concept Clinical Trial Survey	25	Concept Clinical Trial Survey
Attach 1W - 8121 CTSU Data Transmittal Form	23	Attach 1W - 8121 CTSU Data Transmittal Form
Attach 1X- Site Initiated Data Update Form, Protocol 8121	24	Attach 1X- Site Initiated Data Update Form, Protocol 8121
Attach 1Y - USMCI 8214/Z6091: CTSU Data Transmittal	25	Attach 1Y - USMCI 8214/Z6091: CTSU Data Transmittal
Attach 1Z - USMCI 8214/Z6091 Crossover Request/Checklist Transmittal Form	26	Attach 1Z - USMCI 8214/Z6091 Crossover Request/Checklist Transmittal Form
Attach 7 - Prospective Clinical Trial Survey	26	Prospective Clinical Trial Survey
Attach 8 - Low Accruing Clinical Trial Survey	27	Low Accrual Clinical Trial Survey
Attach 1J - N0147 CTSU Data Transmittal Form	10	Attach 1J - N0147 CTSU Data Transmittal Form
Attach 1K - Site Initiated Data Update Form (DUF), Protocol: NCCTG N0147	11	Attach 1K - Site Initiated Data Update Form (DUF), Protocol: NCCTG N0147
Attach 1L - TAILORX/PACCT 1 CTSU Data Transmittal Form	12	Attach 1L - TAILORX/PACCT 1 CTSU Data Transmittal Form
Attach 1A - CTSU IRB/Regulatory Approval Transmittal Form	1	CTSU IRB/Regulatory Approval Transmittal Form
Attach 1B - CTSU IRB Certification Form	2	CTSU IRB Certification Form
Attach 1C- CTSU Acknowledgement Form	3	CTSU Acknowledgement Form
Attach 1D - Optional Form 1 - Withdrawal from Protocol Participation Form	4	Optional Form 1 - Withdrawal from Protocol Participation
Attach 1F - CTSU Roster Update Form	6	CTSU Roster Update Form
Attach 1G - CTSU Radiation Therapy Facilities Inventory Form	7	CTSU Radiation Therapy Facilities Inventory Form
Attach 1H - CTSU IBCSG Drug Accountability Form	8	CTSU IBCSG Drug Accountability Form
Attach 1I - CTSU IBCSG Transfer of Investigational Agent Form	9	CTSU IBCSG Transfer of Investigational Agent Form
Attach 1J - Site Initiated Data Update Form (generic)	10	Site Initiated Data Update Form
Attach 1K - Data Clarification Form	11	Data Clarification Form
Attach 1N - Unsolicited Data Modification Form (UDM), Protocol:TAILORx/PACCT1	14	Attach 1N - Unsolicited Data Modification Form (UDM), Protocol:TAILORx/PACCT1
Attach 1O - Z4032 CTSU Data Transmittal Form	15	Attach 1O - Z4032 CTSU Data Transmittal Form
Attach 1P - Z1031 CTSU Data Transmittal Form	16	Attach 1P - Z1031 CTSU Data Transmittal Form
Attach 2 - CTSU Web Site Customer Satisfaction Survey	23	OPEN-Website Survey
Attach 3 - CTSU Helpdesk Customer Satisfaction Survey	22	Help Desk Survey Customer Satisfaction Survey
Attach 4 - CTSU Oncology Patient Enrollment Network (OPEN) Survey	23	Oncology Patient Enrollment Network (OPEN) Survey
Attach 1N - CTSU Generic Data Transmittal Form	14	CTSU Generic Data Transmittal Form

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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	237,560	289,918	0	-52,358	0	0
Annual Time Burden (Hours)	25,204	34,827	0	-9,623	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: Changing Forms

Short Statement: This program change is being submitted as a revised information collection and includes minor updates to forms and the customer satisfaction surveys. Additionally, several forms are no longer required for collection, which results in a decrease of 9,623 burden hours and about a 20% cost reduction associated with this project. The Protocol and Information Office Customer Satisfaction Survey has been added to this submission and it is anticipated that information collection will occur annually. Additionally, three surveys related to clinical trial ideas, opening and accrual, and low accruals have been added to this information collection.

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Annual Cost to Federal Government: $1,953,405

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 12/06/2013

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