CTEP Branch Support Contracts Forms and Surveys (NCI)

ICR 201908-0925-003

OMB: 0925-0753

Federal Form Document

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Supplementary Document
2019-08-14
Justification for No Material/Nonsubstantive Change
2019-08-14
Supplementary Document
2019-07-01
Justification for No Material/Nonsubstantive Change
2019-07-01
Supplementary Document
2018-09-24
Supplementary Document
2018-09-24
Supplementary Document
2018-09-24
Supplementary Document
2018-09-24
Supplementary Document
2018-09-24
Supplementary Document
2018-09-24
Supplementary Document
2018-09-24
Supplementary Document
2018-09-24
Supplementary Document
2018-09-24
Supplementary Document
2018-09-24
Justification for No Material/Nonsubstantive Change
2018-09-24
Supporting Statement B
2018-04-30
Supplementary Document
2018-04-30
Supplementary Document
2018-04-30
Supplementary Document
2018-04-30
Supplementary Document
2018-04-30
Supplementary Document
2018-04-30
Supplementary Document
2018-04-30
Supplementary Document
2018-04-30
Supplementary Document
2018-04-30
Supplementary Document
2018-04-30
Supplementary Document
2018-04-30
Supporting Statement A
2018-04-30
IC Document Collections
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ICR Details
0925-0753 201908-0925-003
Active 201906-0925-003
HHS/NIH
CTEP Branch Support Contracts Forms and Surveys (NCI)
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 08/28/2019
Retrieve Notice of Action (NOA) 08/15/2019
  Inventory as of this Action Requested Previously Approved
07/31/2021 07/31/2021 07/31/2021
207,989 0 207,989
112,838 0 112,838
0 0 0

This is a revised information collection for OMB control number #0925-0753, expiration 6/30/2020 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 implements programs to register clinical site investigators and clinical site staff, and to oversee the conduct of research at the clinical sites. CTEP and DCP also oversee two support programs, the NCI Central Institutional Review Board (CIRB) and the Cancer Trial Support Unit (CTSU). The combined systems and processes for initiating and managing clinical trials is termed the Clinical Oncology Research Enterprise (CORE) and represents an integrated set of information systems and processes which support investigator registration, trial oversight, patient enrollment, and clinical data collection. The information collected is required to ensure compliance with applicable federal regulations governing the conduct of human subjects research (45 CFR 46 and 21 CRF 50), and when CTEP acts as the Investigational New Drug (IND) holder (FDA regulations pertaining to the sponsor of clinical trials and the selection of qualified investigators under 21 CRF 312.53).

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

Not associated with rulemaking

  83 FR 7483 02/21/2018
83 FR 18576 04/27/2018
No

75
IC Title Form No. Form Name
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
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
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
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 Transfer Worksheet
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 Withdrawal Form
Site Initated Data Update Form (Attachment A8) 8 Site Data Update form
Request Waiver of Assent Form (Attachment B46) 83 Waiver Assent Worksheet
Audit Maintenance Form (Attachment D03) 86 Aud Maint
Final Report and CAPA Request Form (Attachment D07) 90 Final Report CAPA Reg.
NCI CIRB AA & DOR between the NCI CIRB and Signatory Institution (Attachment B1) 18 NCI CIRB AA DivofResps
Adult Cooperative Group Response to CIRB Review (Attachment B27) 43 Adult & CPC FB SCRWksht
CIRB Member COI Screening Worksheet (Attachment B8) 24 CIRB COI Update
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
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 Current CIRB Stat Reviewer Worksheet
CIRB Application for Translated Documents (Attachment B33) 49 CIRB App for Translated Docs
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
CTSU Request for Clinical Brochure (Attachment A6) 6 Clinical Brochure
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
Follow-up survey (Communication Audit) (Attachment C5) 66 CIRB FUP Survey
Reviewer Worksheet of Translated Documents (Attachment B34) 50 Reviewer Worksheet Translated Docs
Study-Specific worksheet About Local Context (Attachment B42) 58 SSW Worksheet
CTSU LPO Form Creation (Attachment A19) 79 Protocol Specific DTL
CIRB Board Member Application (Attachment B3) 82 Board member application
NCI/DCTD/CTEP FDA Form 1572 for Annual Submission (Attachment E01) 91 CTEP FDA Form 1572 for Annual Submission
CTSU OPEN Rave Request Form (Attachment A18) 76 CTSU-OPEN Rave-Form
Final Audit Finding Report Form (Attachment D04) 87 Final Audit Finding
CTSU Site Form Creation and PDF (Attachment A20) 80 Site Prot DTL
CTSU PDF Signature Form (Attachment 21) 81 Elec Sig Page
Audit Scheduling Form (Attachment D01) 84 Audit Schedule
Preliminary Audit Findings Form (Attachment D02) 85 Preliminary Audit Findings
NCI/DCTD/CTEP Agent Shipment Form (ASF) (Attachment E04) 94 Shipment Form (ASF)
Follow-up Form (Attachment D05) 88 Follow up
Roster Maintenance Form (Attachment D06) 89 Roster Maintenance
NCI/DCTD/CTEP Biosketch (Attachment E02) 92 Biosketch
NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03) 93, 1 Fin Disclosure ,   Financial Disclosure
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 CIRB Board Member Annual Assessment
Adult Expedited Study Chair Response to Required Mod (Attachment B29) 45 ER SCRwksht CIRB-ReviewRegMods
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 Supply Request Form (Attachment A7) 7 Supply
CTSU Transfer Form (Attachment A16) 16 Transfer
CIRB Continuing Review Application (Attachment B14) 30 CIRB CR Application
Pediatric Amendment of Cooperative Group Protocol (Attachment B20) 36 Ped AR FB Reviewer Worksheet
Prospective Clinical Trial Survey (Attachment C10) 74 Prospective Survey
CIRB IR Application for Exempt Studies (Attachment B11) 27 CIRB IR Exempt Application
NCI CIRB Signatory Enrollment Form (Attachment B2) 19 NCI CIRB Signatory Enrollment Form

  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 207,989 207,989 0 0 0 0
Annual Time Burden (Hours) 112,838 112,838 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$1,613,105
Yes Part B of Supporting Statement
    Yes
    Yes
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.
08/15/2019


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