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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 5 Attach 1Di_Site Addition Form	Form and Instruction	Modified	Available
Form 33 Attach 1GG - CTSU Generic Data Transmittal Form	Form and Instruction	Modified	Available
Form 36 Attach 4 - CTSU OPEN Survey	Form	Modified	Available
Form 35 Attach 3 - CTSU Helpdesk Customer Satisfaction Survey	Form	Modified	Available
Form 34 Attach 2 - CTSU Web Site Customer Satisfaction Survey	Form	Modified	Available
Form 32 Attach 1FF - CTSU Supply Request Form	Form and Instruction	Modified	Available
Form 31 Attach 1EE - CTSU Request for Clinical Brochure	Form and Instruction	Modified	Available
Form 30 Attach 1DD - CTSU System Account Request Form	Form and Instruction	Modified	Available
Form 29 Attach 1CC - CTSU Transfer Form	Form and Instruction	Modified	Available
Form 28 Attach 1BB - CTSU P2C Enrollment Transmittal Form	Form and Instruction	Modified	Available
Form 27 Attach 1AA - CTSU Patient Enrollment Transmittal Form	Form and Instruction	Modified	Available
Form 26 Attach 1Z - USMCI 8214/Z6091 Crossover Request/Checklist Transmittal Form	Form and Instruction	Modified	Available
Form 25 Attach 1Y - USMCI 8214/Z6091: CTSU Data Transmittal	Form and Instruction	Modified	Available
Form 24 Attach 1X- Site Initiated Data Update Form, Protocol 8121	Form and Instruction	Modified	Available
Form 23 Attach 1W - 8121 CTSU Data Transmittal Form	Form and Instruction	Modified	Available
Form 22 Attach 1V - MC0845(8233) CTSU Data Transmittal	Form and Instruction	Modified	Available
Form 21 Attach 1U - Site Initiated Data Update Form, protocol 7868	Form and Instruction	Modified	Available
Form 20 Attach 1T - CTSU 7868 Data Transmittal Form	Form and Instruction	Modified	Available
Form 19 Attach 1S - RTOG 0834 CTSU Data Transmittal Form	Form and Instruction	Modified	Available
Form 18 Attach 1R - Z6051 CTSU Data Transmittal Form	Form and Instruction	Modified	Available
Form 17 Attach 1Q - Z1041 CTSU Data Transmittal Form	Form and Instruction	Modified	Available
Form 16 Attach 1P - Z1031 CTSU Data Transmittal Form	Form and Instruction	Modified	Available
Form 15 Attach 1O - Z4032 CTSU Data Transmittal Form	Form and Instruction	Modified	Available
Form 14 Attach 1N - Unsolicited Data Modification Form (UDM), Protocol:TAILORx/PACCT1	Form and Instruction	Modified	Available
Form 13 Attach 1M - Data Clarification Form	Form and Instruction	Modified	Available
Form 12 Attach 1L - TAILORX/PACCT 1 CTSU Data Transmittal Form	Form and Instruction	Modified	Available
Form 11 Attach 1K - Site Initiated Data Update Form (DUF), Protocol: NCCTG N0147	Form and Instruction	Modified	Available
Form 10 Attach 1J - N0147 CTSU Data Transmittal Form	Form and Instruction	Modified	Available
Form 9 Attach 1I - Site Initiated Data Update Form (generic)	Form and Instruction	Modified	Available
Form 8 Attach 1H - CTSU IBCSG Transfer of Investigational Agent Form	Form and Instruction	Modified	Available
Form 7 Attach 1G - CTSU IBCSG Drug Accountability Form	Form and Instruction	Modified	Available
Form 6 Attach 1F - CTSU Radiation Therapy Facilities Inventory Form	Form and Instruction	Modified	Available
Form 5 Attach 1E - CTSU Roster Update Form Version 2	Form and Instruction	Modified	Available
Form 4 Attach 1D - Optional Form 1 - Withdrawal from Protocol Participation Form	Form and Instruction	Modified	Available
Form 3 Attach 1C- CTSU Acknowledgement Form	Form and Instruction	Modified	Available
Form 2 Attach 1B - CTSU IRB Certification Form v. 2_July 2011	Form and Instruction	Modified	Available
Form 1 Attach 1A - CTSU IRB/Regulatory Approval Transmittal Form	Form and Instruction	Modified	Available
attachment_1cc.pdf	Supplementary Document	Uploaded 2012-11-27	Available
attachment_1e.pdf	Supplementary Document	Uploaded 2012-11-27	Available
Change Request_CTSU_11-27-2012.doc	Justification for No Material/Nonsubstantive Change	Uploaded 2012-11-27	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
199005	Attach 1Di_CTSU Site Addition Form	Form and Instruction	Modified	Attach 1Di_Site Addition Form
195188	Attach 1GG - CTSU Generic Data Transmittal Form	Form and Instruction	Modified	Attach 1GG - CTSU Generic Data Transmittal Form
195187	Attach 4 - CTSU OPEN Survey	Form	Modified	Attach 4 - CTSU OPEN Survey
195186	Attach 3 - CTSU Helpdesk Customer Satisfaction Survey	Form	Modified	Attach 3 - CTSU Helpdesk Customer Satisfaction Survey
195185	Attach 2 - CTSU Web Site Customer Satisfaction Survey	Form	Modified	Attach 2 - CTSU Web Site Customer Satisfaction Survey
195184	Attach 1FF - CTSU Supply Request Form	Form and Instruction	Modified	Attach 1FF - CTSU Supply Request Form
195183	Attach 1EE - CTSU Request for Clinical Brochure	Form and Instruction	Modified	Attach 1EE - CTSU Request for Clinical Brochure
195182	Attach 1DD - CTSU System Account Request Form	Form and Instruction	Modified	Attach 1DD - CTSU System Account Request Form
195181	Attach 1CC - CTSU Transfer Form	Form and Instruction	Modified	Attach 1CC - CTSU Transfer Form
195180	Attach 1BB - CTSU P2C Enrollment Transmittal Form	Form and Instruction	Modified	Attach 1BB - CTSU P2C Enrollment Transmittal Form
195179	Attach 1AA - CTSU Patient Enrollment Transmittal Form	Form and Instruction	Modified	Attach 1AA - CTSU Patient Enrollment Transmittal Form
195178	Attach 1Z - USMCI 8214/Z6091 Crossover Request/Checklist Transmittal Form	Form and Instruction	Modified	Attach 1Z - USMCI 8214/Z6091 Crossover Request/Checklist Transmittal Form
195177	Attach 1Y - USMCI 8214/Z6091: CTSU Data Transmittal	Form and Instruction	Modified	Attach 1Y - USMCI 8214/Z6091: CTSU Data Transmittal
195176	Attach 1X- Site Initiated Data Update Form, Protocol 8121	Form and Instruction	Modified	Attach 1X- Site Initiated Data Update Form, Protocol 8121
195175	Attach 1W - 8121 CTSU Data Transmittal Form	Form and Instruction	Modified	Attach 1W - 8121 CTSU Data Transmittal Form
195174	Attach 1V - MC0845(8233) CTSU Data Transmittal	Form and Instruction	Modified	Attach 1V - MC0845(8233) CTSU Data Transmittal
195173	Attach 1U - Site Initiated Data Update Form, protocol 7868	Form and Instruction	Modified	Attach 1U - Site Initiated Data Update Form, protocol 7868
195172	Attach 1T - CTSU 7868 Data Transmittal Form	Form and Instruction	Modified	Attach 1T - CTSU 7868 Data Transmittal Form
195171	Attach 1S - RTOG 0834 CTSU Data Transmittal Form	Form and Instruction	Modified	Attach 1S - RTOG 0834 CTSU Data Transmittal Form
195170	Attach 1R - Z6051 CTSU Data Transmittal Form	Form and Instruction	Modified	Attach 1R - Z6051 CTSU Data Transmittal Form
195169	Attach 1Q - Z1041 CTSU Data Transmittal Form	Form and Instruction	Modified	Attach 1Q - Z1041 CTSU Data Transmittal Form
195168	Attach 1P - Z1031 CTSU Data Transmittal Form	Form and Instruction	Modified	Attach 1P - Z1031 CTSU Data Transmittal Form
195167	Attach 1O - Z4032 CTSU Data Transmittal Form	Form and Instruction	Modified	Attach 1O - Z4032 CTSU Data Transmittal Form
195166	Attach 1N - Unsolicited Data Modification Form (UDM), Protocol:TAILORx/PACCT1	Form and Instruction	Modified	Attach 1N - Unsolicited Data Modification Form (UDM), Protocol:TAILORx/PACCT1
195165	Attach 1M - Data Clarification Form	Form and Instruction	Modified	Attach 1M - Data Clarification Form
195164	Attach 1L - TAILORX/PACCT 1 CTSU Data Transmittal Form	Form and Instruction	Modified	Attach 1L - TAILORX/PACCT 1 CTSU Data Transmittal Form
195163	Attach 1K - Site Initiated Data Update Form (DUF), Protocol: NCCTG N0147	Form and Instruction	Modified	Attach 1K - Site Initiated Data Update Form (DUF), Protocol: NCCTG N0147
195162	Attach 1J - N0147 CTSU Data Transmittal Form	Form and Instruction	Modified	Attach 1J - N0147 CTSU Data Transmittal Form
195161	Attach 1I - Site Initiated Data Update Form (generic)	Form and Instruction	Modified	Attach 1I - Site Initiated Data Update Form (generic)
195160	Attach 1H - CTSU IBCSG Transfer of Investigational Agent Form	Form and Instruction	Modified	Attach 1H - CTSU IBCSG Transfer of Investigational Agent Form
195159	Attach 1G - CTSU IBCSG Drug Accountability Form	Form and Instruction	Modified	Attach 1G - CTSU IBCSG Drug Accountability Form
195158	Attach 1F - CTSU Radiation Therapy Facilities Inventory Form	Form and Instruction	Modified	Attach 1F - CTSU Radiation Therapy Facilities Inventory Form
195157	Attach 1E - CTSU Roster Update Form	Form and Instruction	Modified	Attach 1E - CTSU Roster Update Form Version 2
195156	Attach 1D - Optional Form 1 - Withdrawal from Protocol Participation Form	Form and Instruction	Modified	Attach 1D - Optional Form 1 - Withdrawal from Protocol Participation Form
195155	Attach 1C- CTSU Acknowledgement Form	Form and Instruction	Modified	Attach 1C- CTSU Acknowledgement Form
195154	Attach 1B - CTSU IRB Certification Form	Form and Instruction	Modified	Attach 1B - CTSU IRB Certification Form v. 2_July 2011
195153	Attach 1A - CTSU IRB/Regulatory Approval Transmittal Form	Form and Instruction	Modified	Attach 1A - CTSU IRB/Regulatory Approval Transmittal Form

ICR Details

OMB Control No: 0925-0624	ICR Reference No: 201211-0925-011
Status: Historical Active	Previous ICR Reference No: 201206-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Cancer Trials Support Unit (CTSU) Public Use Forms and Customer Satisfaction Surveys (NCI)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/29/2012
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/27/2012
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2013	12/31/2013	12/31/2013
Responses	289,918	0	289,918
Time Burden (Hours)	34,827	0	34,827
Cost Burden (Dollars)	0	0	0

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Abstract: The CTSU collects standardized forms to support regulatory processing, patient enrollments, and data collection. In addition, the CTSU performs routine customer satisfaction surveys to assess help desk, web site, and patient enrollment services. The Supporting Statements A and B gives details on form and survey collection and processing.

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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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 37

table that charts list of burden

IC Title	Form No.	Form Name
Attach 1A - CTSU IRB/Regulatory Approval Transmittal Form	1	Attach 1A - CTSU IRB/Regulatory Approval Transmittal Form
Attach 1AA - CTSU Patient Enrollment Transmittal Form	27	Attach 1AA - CTSU Patient Enrollment Transmittal Form
Attach 1B - CTSU IRB Certification Form	2	Attach 1B - CTSU IRB Certification Form v. 2_July 2011
Attach 1BB - CTSU P2C Enrollment Transmittal Form	28	Attach 1BB - CTSU P2C Enrollment Transmittal Form
Attach 1C- CTSU Acknowledgement Form	3	Attach 1C- CTSU Acknowledgement Form
Attach 1CC - CTSU Transfer Form	29	Attach 1CC - CTSU Transfer Form
Attach 1D - Optional Form 1 - Withdrawal from Protocol Participation Form	4	Attach 1D - Optional Form 1 - Withdrawal from Protocol Participation Form
Attach 1DD - CTSU System Account Request Form	30	Attach 1DD - CTSU System Account Request Form
Attach 1Di_CTSU Site Addition Form	5	Attach 1Di_Site Addition Form
Attach 1E - CTSU Roster Update Form	5	Attach 1E - CTSU Roster Update Form Version 2
Attach 1EE - CTSU Request for Clinical Brochure	31	Attach 1EE - CTSU Request for Clinical Brochure
Attach 1F - CTSU Radiation Therapy Facilities Inventory Form	6	Attach 1F - CTSU Radiation Therapy Facilities Inventory Form
Attach 1FF - CTSU Supply Request Form	32	Attach 1FF - CTSU Supply Request Form
Attach 1G - CTSU IBCSG Drug Accountability Form	7	Attach 1G - CTSU IBCSG Drug Accountability Form
Attach 1GG - CTSU Generic Data Transmittal Form	33	Attach 1GG - CTSU Generic Data Transmittal Form
Attach 1H - CTSU IBCSG Transfer of Investigational Agent Form	8	Attach 1H - CTSU IBCSG Transfer of Investigational Agent Form
Attach 1I - Site Initiated Data Update Form (generic)	9	Attach 1I - Site Initiated Data Update Form (generic)
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 1M - Data Clarification Form	13	Attach 1M - 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 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 1S - RTOG 0834 CTSU Data Transmittal Form	19	Attach 1S - RTOG 0834 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 1V - MC0845(8233) CTSU Data Transmittal	22	Attach 1V - MC0845(8233) CTSU Data Transmittal
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 2 - CTSU Web Site Customer Satisfaction Survey	34	Attach 2 - CTSU Web Site Customer Satisfaction Survey
Attach 3 - CTSU Helpdesk Customer Satisfaction Survey	35	Attach 3 - CTSU Helpdesk Customer Satisfaction Survey
Attach 4 - CTSU OPEN Survey	36	Attach 4 - CTSU OPEN Survey

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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	289,918	289,918	0	0	0	0
Annual Time Burden (Hours)	34,827	34,827	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: $2,520,343

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: 11/27/2012

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