CTEP Support Contracts Forms and Surveys (NCI)

ICR 201702-0925-003

OMB: 0925-0753

Federal Form Document

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Supplementary Document
2017-03-07
Supplementary Document
2017-03-03
Supplementary Document
2017-03-03
Supplementary Document
2017-03-03
Supplementary Document
2017-03-03
Supplementary Document
2017-03-03
Supplementary Document
2017-03-03
Supplementary Document
2017-03-03
Supporting Statement A
2017-05-31
Supporting Statement B
2017-02-28
IC Document Collections
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225931 New
225930 New
225929 New
225928 New
225927 New
225926 New
225925 New
225924 New
225923 New
225922 New
225921 New
225919 New
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225843 New
225841 New
ICR Details
0925-0753 201702-0925-003
Historical Active
HHS/NIH
CTEP Support Contracts Forms and Surveys (NCI)
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 06/01/2017
Retrieve Notice of Action (NOA) 03/07/2017
  Inventory as of this Action Requested Previously Approved
06/30/2020 36 Months From Approved
100,337 0 0
15,524 0 0
0 0 0

This is a new information collection seeking approval for three years. The National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) and the Division of Cancer Prevention (DCP) fund an extensive national program of cancer research, sponsoring clinical trials in cancer prevention, symptom management and treatment for qualified clinical investigators. As part of this effort, CTEP and DCP oversee two support programs, the NCI Central Institutional Review Board (CIRB) and the Cancer Trial Support Unit (CTSU). The information collected for both programs is for the purposes of membership, enrollment, opening of Institutional Review Board (IRB) approved studies, documenting IRB review, regulatory approval (for sites not using the CIRB), patient enrollment, and routing of case report forms. Information will also be collected through surveys to assess satisfaction and provide feedback to guide improvements with processes and technology as well as assessing health professional’s interests in clinical trials.

US Code: 42 USC 285a Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  81 FR 89955 12/13/2016
82 FR 12618 03/06/2017
No

74
IC Title Form No. Form Name
MC0845 (8233) CTSU Data Transmittal Form (Attachment A11) 11 8233 Form
CTSU Transfer Form (Attachment A16) 16 Transfer
NCI CIRB Signatory Enrollment Form (Attachment B2) 19 NCI CIRB Signatory Enrollment Form
CIRB Board Member NDA (Attachment B6) 22 CIRB Member NDA
CIRB Member COI Screening Worksheet (Attachment B8) 24 COI Screen
CIRB COI Screening for CIRB meetings (Attachment B9) 25 COI Screening
CIRB Ancillary Studies Application (Attachment B13) 29 CIRB Ancillary Application
Adult IR of cooperative Group Protocol (Attachment B15) 31 Adult IR FB Reviewer Worksheet
Adult Continuing Review of Cooperative Group Protocol (Attachment B17) 33 Adult CR FB Reviewer Worksheet
Pediatric Continuing Review of Cooperative Group Protocol (Attachment B18) 34 Oed CR FB Reviewer Worksheet
Adult Expedited Amendment Review (Attachment B23) 39 Adult & CPC Expedited Reviewer Worksheet
Pediatric Expedited Continuing Review (Attachment B26) 42 Ped Expedited CR Worksheet
Pediatric Cooperative Group Response to CIRB Review (Attachment B28) 44 Ped FB SCRWksht
Reviewer worksheet CIRB Statistical Reviewer Form (Attachment B32) 48 reviewer Worksheet CIRB Stat
CIRB Application for Translated Documents (Attachment B33) 49 CIRB App for Translated Docs
Reviewer Worksheet CPC - Determination of UP or SCN (Attachment B39) 55 Reviewer Worksheet CPC UP FB
Website Focus Groups, Communication Project (Attachments C6 A-D) 69, 70, 67, 68 CIRB Website Focus Group Survey - CIRB Members usability ,   CIRB Website Focus Group Survey - Local Instiutions usability ,   CIRB Website Focus Group Survey - Network Groups usability ,   CIRB Website Focus Group Survey -Web site usability testing
PIO Customer Satisfaction Survey (Attachment C8) 72 PIO External Survey
Low Accural clinical Trial Survey (Attachment C11) 75 low accuring survey
CIRB Amendment Review Application (Attachment B12) 28 CIRB AR Application
Pediatric IR of Cooperative Group Protocol (Attachment B16) 32 Ped IR FB Reviewerworksheet
Adult amendment of Cooperative Group Protocol (Attachment B19) 35 Adult AR FB Reviewer Worksheet
Pediatric Expedited Strudy Chair Response to Required Mod (Attachment B30) 46 Ped Exped Chair Resp Req Mods
Reviewer worksheet Expedited Study Closure Review (Attachment B36) 52 reviewer Worksheet ER ClosureWksht
Reviewer Worksheet of Expedited IR (Attachment B38) 54 Reviewer Worksheet ER IR
CTSU Help Desk Customer Satisfaction Survey (Attachment C2) 63 Help Desk Survey
Follow-up survey (Communication Audit) (Attachment C5) 66 CIRB FUP Survey
ETCTN PI Survey (Attachment C12) 76 ETCTN PI Survey
Reviewer Worksheet of Translated Documents (Attachment B34) 50 Reviewer Worksheet Translated Docs
Study-Specific worksheet About Local Context (Attachment B42) 58 SSW Worksheet
TAILORx_PACCT1_Data Transmittal Form (Attachment A13) 13 TAILORx PACCT1_DTF
CTSU Generic Data transmittal form (Attachment A12) 12 Generic Data
CTSU System Access Request Form (Attachment A17) 17 System Access Request form
CIRB IR Application (Attachment B10) 26 CIRB IR Application
CPC Pharmacist's Review of Cooperative Group Study (Attachment B22) 38 CPC FB Pharma Reviewer Worksheet
Adult Expedited Continuing Review (Attachment B25) 41 Adult & CPC Expedited CR Worksheet
Annual signatory Institution Worksheet About Local Context (Attachment B40) 56 Annual SI Worksheet
CTSU OPEN Survey (Attachment C3) 64 OPEN survey
CIRB Board member Annual Assessment Survey (Attachment C7) 71 Annual CIRB Board Assessment
Prospective Clinical Trial Survey (Attachment C10) 74 Prospective Survey
Uncolicited Data Modification Form: Protocol: TAILORx/PACCT-1 (Attachment A14) 14 TAILORx UDM
CIRB IR Application for Exempt Studies (Attachment B11) 27 CIRB IR Exempt Application
CIRB Continuing Review Application (Attachment B14) 30 CIRB CR Application
Pediatric Amendment of Cooperative Group Protocol (Attachment B20) 36 Ped AR FB Reviewer Worksheet
Pharmacist's Review of a Cooperative Group Study (Attachment B21) 37 Adult Ped FB Pharma Adult Reviewer Worksheet
Reviewer Worksheet Determination of UP or SCN (Attachment B31) 47 Reviewer Worksheet UP FB
Reviewer Worksheet of Recruitment Material (Attachment B35) 51 Reviewer Worksheet Recruitment materials
Reviewer Worksheet expedited Review of Study Chair Response to CIRB-Required Modifications (Attachment B37) 53 Reviewer Worksheet SCR ER
Annual Principal Investigator Worksheet About Local Context (Attachment B41) 57 Annual PI Worksheet
UP or SCN Reporting Form (Attachment B44) 60 Unanticipated Problem Worksheet
Change of SI PI Form (Attachment B45) 61 Change PI Worksheet
CTSU Website Customer Satisfaction Survey (Attachment C1) 62 websurvey final
CIRB Customer Satisfaction survey (Attachment C4) 65 CIRB Satisfaction survey
Concept Clinical Trial Survey (Attachment C9) 73 Concept Survey
Data Clarification Form (Attachment A9) 9 Data Clarification Form
CIRB Direct Deposit Form (Attachment B7) 23 CIRB Direct Deposit Form
Pediatric Expedited Amendment Review (Attachment B24) 40 Ped Expedited Reviewer Worksheet
Study Closure or Transfer of Study Review Responsibility Form (Attachment B43) 59 Study Closure Worksheet
ETCTN RS Survey (Attachment C13) 77 ETCTN
CTSU IRB Certification Form (Attachment A2) 2 IRB Certification
Site Addition Form (Attachment A4) 4 Site Addition
CTSU IRB/Regulatory Approval Transmittal Form (Attachment A1) 1 IRB Transmittal
Withdrawl from Protocol Participation Form (Attachment A3) 3 Withdrawl form
Site Initated Data Update Form (Attachment A8) 8 Site Data Update form
NCI CIRB AA & DOR between the NCI CIRB and Signatory Institution (Attachment B1) 18 NCI CIRB AA DivofResps
CIRB Board member Biographical Sketch (Attachment B3) 20 CIRB Biosketch Questions CIRB member
CIRB Board member Contact Information Form (Attachment B4) 21 CIRB ContactInfoForm
Adult Cooperative Group Response to CIRB Review (Attachment B27) 43 Adult & CPC FB SCRWksht
Adult Expedited Study Chair Response to Required Mod (Attachment B29) 45 Adult & CPC Exped Chair Resp Req Mods
RTOG 0834 CTSU Data Transmittal Form (Attachment A10) 10 RTOG0834
CTSU Patient Enrollment Transmittal Form (Attachment A15) 15 Patient Enrollment Transmittal form
CTSU Roster Update Form (Attachment A5) 5 Roster Update
CTSU Request for Clinical Brochure (Attachment A6) 6 Clinical Brochure
CTSU Supply Request Form (Attachment A7) 7 Supply

  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 100,337 0 0 100,337 0 0
Annual Time Burden (Hours) 15,524 0 0 15,524 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
New submission

$689,035
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.
03/07/2017


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