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

Forms and Documents

Document Name	Status
Form 5 Attach 1Di_CTSU Site Addition Form Form and Instruction	New
Form 33 Attach 1GG - CTSU Generic Data Transmittal Form Form and Instruction	Modified
Form 36 Attach 4 - CTSU OPEN Survey Form	Modified
Form 35 Attach 3 - CTSU Helpdesk Customer Satisfaction Survey Form	Modified
Form 34 Attach 2 - CTSU Web Site Customer Satisfaction Survey Form	Modified
Form 32 Attach 1FF - CTSU Supply Request Form Form and Instruction	Modified
Form 31 Attach 1EE - CTSU Request for Clinical Brochure Form and Instruction	Modified
Form 30 Attach 1DD - CTSU System Account Request Form Form and Instruction	Modified
Form 29 Attach 1CC - CTSU Transfer Form Form and Instruction	Modified
Form 28 Attach 1BB - CTSU P2C Enrollment Transmittal Form Form and Instruction	Modified
Form 27 Attach 1AA - CTSU Patient Enrollment Transmittal Form Form and Instruction	Modified
Form 26 Attach 1Z - USMCI 8214/Z6091 Crossover Request/Checklist Transmittal Form Form and Instruction	Modified
Form 25 Attach 1Y - USMCI 8214/Z6091: CTSU Data Transmittal Form and Instruction	Modified
Form 24 Attach 1X- Site Initiated Data Update Form, Protocol 8121 Form and Instruction	Modified
Form 23 Attach 1W - 8121 CTSU Data Transmittal Form Form and Instruction	Modified
Form 22 Attach 1V - MC0845(8233) CTSU Data Transmittal Form and Instruction	Modified
Form 21 Attach 1U - Site Initiated Data Update Form, protocol 7868 Form and Instruction	Modified
Form 20 Attach 1T - CTSU 7868 Data Transmittal Form Form and Instruction	Modified
Form 19 Attach 1S - RTOG 0834 CTSU Data Transmittal Form Form and Instruction	Modified
Form 18 Attach 1R - Z6051 CTSU Data Transmittal Form Form and Instruction	Modified
Form 17 Attach 1Q - Z1041 CTSU Data Transmittal Form Form and Instruction	Modified
Form 16 Attach 1P - Z1031 CTSU Data Transmittal Form Form and Instruction	Modified
Form 15 Attach 1O - Z4032 CTSU Data Transmittal Form Form and Instruction	Modified
Form 14 Attach 1N - Unsolicited Data Modification Form (UDM), Protocol:TAILORx/PACCT1 Form and Instruction	Modified
Form 13 Attach 1M - Data Clarification Form Form and Instruction	Modified
Form 12 Attach 1L - TAILORX/PACCT 1 CTSU Data Transmittal Form Form and Instruction	Modified
Form 11 Attach 1K - Site Initiated Data Update Form (DUF), Protocol: NCCTG N0147 Form and Instruction	Modified
Form 10 Attach 1J - N0147 CTSU Data Transmittal Form Form and Instruction	Modified
Form 9 Attach 1I - Site Initiated Data Update Form (generic) Form and Instruction	Modified
Form 8 Attach 1H - CTSU IBCSG Transfer of Investigational Agent Form Form and Instruction	Modified
Form 7 Attach 1G - CTSU IBCSG Drug Accountability Form Form and Instruction	Modified
Form 6 Attach 1F - CTSU Radiation Therapy Facilities Inventory Form Form and Instruction	Modified
Form 5 Attach 1E - 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
Change Request_CTSU.doc Justification for No Material/Nonsubstantive Change	2011-08-17

IC Document Collections

IC ID	Document Title	Status
199005	Attach 1Di_CTSU Site Addition Form Form and Instruction	New
195188	Attach 1GG - CTSU Generic Data Transmittal Form Form and Instruction	Modified
195187	Attach 4 - CTSU OPEN Survey Form	Modified
195186	Attach 3 - CTSU Helpdesk Customer Satisfaction Survey Form	Modified
195185	Attach 2 - CTSU Web Site Customer Satisfaction Survey Form	Modified
195184	Attach 1FF - CTSU Supply Request Form Form and Instruction	Modified
195183	Attach 1EE - CTSU Request for Clinical Brochure Form and Instruction	Modified
195182	Attach 1DD - CTSU System Account Request Form Form and Instruction	Modified
195181	Attach 1CC - CTSU Transfer Form Form and Instruction	Modified
195180	Attach 1BB - CTSU P2C Enrollment Transmittal Form Form and Instruction	Modified
195179	Attach 1AA - CTSU Patient Enrollment Transmittal Form Form and Instruction	Modified
195178	Attach 1Z - USMCI 8214/Z6091 Crossover Request/Checklist Transmittal Form Form and Instruction	Modified
195177	Attach 1Y - USMCI 8214/Z6091: CTSU Data Transmittal Form and Instruction	Modified
195176	Attach 1X- Site Initiated Data Update Form, Protocol 8121 Form and Instruction	Modified
195175	Attach 1W - 8121 CTSU Data Transmittal Form Form and Instruction	Modified
195174	Attach 1V - MC0845(8233) CTSU Data Transmittal Form and Instruction	Modified
195173	Attach 1U - Site Initiated Data Update Form, protocol 7868 Form and Instruction	Modified
195172	Attach 1T - CTSU 7868 Data Transmittal Form Form and Instruction	Modified
195171	Attach 1S - RTOG 0834 CTSU Data Transmittal Form Form and Instruction	Modified
195170	Attach 1R - Z6051 CTSU Data Transmittal Form Form and Instruction	Modified
195169	Attach 1Q - Z1041 CTSU Data Transmittal Form Form and Instruction	Modified
195168	Attach 1P - Z1031 CTSU Data Transmittal Form Form and Instruction	Modified
195167	Attach 1O - Z4032 CTSU Data Transmittal Form Form and Instruction	Modified
195166	Attach 1N - Unsolicited Data Modification Form (UDM), Protocol:TAILORx/PACCT1 Form and Instruction	Modified
195165	Attach 1M - Data Clarification Form Form and Instruction	Modified
195164	Attach 1L - TAILORX/PACCT 1 CTSU Data Transmittal Form Form and Instruction	Modified
195163	Attach 1K - Site Initiated Data Update Form (DUF), Protocol: NCCTG N0147 Form and Instruction	Modified
195162	Attach 1J - N0147 CTSU Data Transmittal Form Form and Instruction	Modified
195161	Attach 1I - Site Initiated Data Update Form (generic) Form and Instruction	Modified
195160	Attach 1H - CTSU IBCSG Transfer of Investigational Agent Form Form and Instruction	Modified
195159	Attach 1G - CTSU IBCSG Drug Accountability Form Form and Instruction	Modified
195158	Attach 1F - CTSU Radiation Therapy Facilities Inventory Form Form and Instruction	Modified
195157	Attach 1E - 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: 201108-0925-003
Status: Historical Active	Previous ICR Reference No: 201011-0925-002
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: 08/26/2011
	Date Received in OIRA: 08/25/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2013	12/31/2013	12/31/2013
Responses	289,918	0	289,618
Time Burden (Hours)	34,827	0	34,802
Cost Burden (Dollars)	0	0	0

---

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.

---

Authorizing Statute(s): US Code: 42 USC 413(285a-2) 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

Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
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 1BB - CTSU P2C Enrollment Transmittal Form	28	Attach 1BB - CTSU P2C Enrollment Transmittal Form
Attach 1CC - CTSU Transfer Form	29	Attach 1CC - CTSU Transfer Form
Attach 1H - CTSU IBCSG Transfer of Investigational Agent Form	8	Attach 1H - CTSU IBCSG Transfer of Investigational Agent Form
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 1A - CTSU IRB/Regulatory Approval Transmittal Form	1	Attach 1A - CTSU IRB/Regulatory Approval Transmittal Form
Attach 1B - CTSU IRB Certification Form	2	Attach 1B - CTSU IRB Certification Form v. 2_July 2011
Attach 1C- CTSU Acknowledgement Form	3	Attach 1C- CTSU Acknowledgement Form
Attach 1D - Optional Form 1 - Withdrawal from Protocol Participation Form	4	Attach 1D - Optional Form 1 - Withdrawal from Protocol Participation Form
Attach 1E - CTSU Roster Update Form	5	Attach 1E - CTSU Roster Update Form Version 2
Attach 1F - CTSU Radiation Therapy Facilities Inventory Form	6	Attach 1F - CTSU Radiation Therapy Facilities Inventory Form
Attach 1G - CTSU IBCSG Drug Accountability Form	7	Attach 1G - CTSU IBCSG Drug Accountability Form
Attach 1Z - USMCI 8214/Z6091 Crossover Request/Checklist Transmittal Form	26	Attach 1Z - USMCI 8214/Z6091 Crossover Request/Checklist Transmittal Form
Attach 1AA - CTSU Patient Enrollment Transmittal Form	27	Attach 1AA - CTSU Patient Enrollment Transmittal 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 1DD - CTSU System Account Request Form	30	Attach 1DD - CTSU System Account Request Form
Attach 1EE - CTSU Request for Clinical Brochure	31	Attach 1EE - CTSU Request for Clinical Brochure
Attach 1FF - CTSU Supply Request Form	32	Attach 1FF - CTSU Supply Request 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
Attach 1GG - CTSU Generic Data Transmittal Form	33	Attach 1GG - CTSU Generic Data Transmittal Form
Attach 1Di_CTSU Site Addition Form	5	Attach 1Di_Site Addition Form

---

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	289,918	289,618	0	300	0	0
Annual Time Burden (Hours)	34,827	34,802	0	25	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: There is a new regulatory form that has not previously been submitted. This form is now being added to facilitate the addition of new clinical sites to an already existing IRB approval within a network.

---

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

---

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: 08/25/2011

---