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

ICR 201601-0925-003

OMB: 0925-0624

Federal Form Document

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Justification for No Material/Nonsubstantive Change
2016-01-20
Supplementary Document
2015-03-03
Supplementary Document
2015-01-23
Supplementary Document
2015-01-23
Supplementary Document
2014-09-19
Supplementary Document
2014-09-19
Supplementary Document
2014-09-19
Supplementary Document
2014-09-19
Justification for No Material/Nonsubstantive Change
2014-09-19
Supporting Statement B
2013-10-30
Supplementary Document
2013-10-30
Supplementary Document
2013-10-30
Supplementary Document
2013-10-30
Supplementary Document
2013-10-30
Supporting Statement A
2013-11-19
IC Document Collections
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215510
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209614 Unchanged
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199005 Unchanged
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ICR Details
0925-0624 201601-0925-003
Historical Active 201501-0925-005
HHS/NIH 20796
Cancer Trials Support Unit (CTSU) Public Use Forms and Customer Satisfaction Surveys (NCI)
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 01/28/2016
Retrieve Notice of Action (NOA) 01/27/2016
  Inventory as of this Action Requested Previously Approved
01/31/2017 01/31/2017 01/31/2017
237,560 0 246,632
25,204 0 26,716
0 0 0

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.

US Code: 42 USC 413(285a-2) Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  78 FR 53763 08/30/2013
78 FR 69428 11/19/2013
No

27
IC Title Form No. Form Name
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 1K - Data Clarification Form 11 Data Clarification Form
Attach 1L - RTOG 0834 CTSU Data Transmittal Form 12 RTOG 0834 CTSU Data Transmittal Form
Attach 1J - Site Initiated Data Update Form (generic) 10 Site Initiated Data Update Form
Attach 1A - CTSU IRB/Regulatory Approval Transmittal Form 1 Attachment 1-CTSU IRB Regulatory Approval Transmittal Form
CTSU Data Transmittal Form for TailorX/PACCT-1 (Attachment 1u)
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 1M - MC0845(8233) CTSU Data Transmittal 13 MC0845 (8233) CTSU Data Transmittal 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 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 7 - Prospective Clinical Trial Survey 26 Prospective Clinical Trial Survey
Attach 8 - Low Accruing Clinical Trial Survey 27 Low Accrual Clinical Trial Survey
Attach 1Q - CTSU Transfer Form 17 CTSU Transfer Form
Attach 1R - CTSU System Account Request Form 18 CTSU System Account Request Form
Attach 1P - CTSU P2C Enrollment Transmittal Form 16 CTSU P2C Enrollment Transmittal Form
Attach 1o - CTSU Patient Enrollment Transmittal Form 15 CTSU Patient Enrollment Transmittal Form
Attach 1N - CTSU Generic Data Transmittal Form 14 CTSU Generic Data Transmittal 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

  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 237,560 246,632 0 0 -9,072 0
Annual Time Burden (Hours) 25,204 26,716 0 0 -1,512 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$1,953,405
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Tawanda Abdelmouti 240 276-5530 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
01/27/2016


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