CTEP Branch Support Contracts Forms and Surveys (NCI)

ICR 202012-0925-003

OMB: 0925-0753

Federal Form Document

Forms and Documents
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Status
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Supplementary Document
2021-02-16
Supporting Statement A
2021-01-29
Supporting Statement B
2021-01-29
Supplementary Document
2021-01-28
Supplementary Document
2021-01-28
Supplementary Document
2021-01-28
Supplementary Document
2021-01-28
Supplementary Document
2021-01-28
Supplementary Document
2021-01-28
Supplementary Document
2021-01-28
Supplementary Document
2021-01-28
IC Document Collections
IC ID
Document
Title
Status
245475 New
245474 New
245472 New
230005 Modified
230004 Modified
230003 Modified
230002 Modified
230001 Modified
230000 Modified
229999 Modified
229998 Modified
229997 Modified
229995 Modified
229993 Unchanged
229991 Modified
229989 Modified
229988 Modified
229986 Unchanged
229985 Unchanged
229984 Modified
225929 Removed
225928 Removed
225927 Removed
225926 Modified
225925 Modified
225923 Modified
225922 Modified
225921 Modified
225917 Modified
225916 Unchanged
225915 Modified
225914 Modified
225913 Modified
225912 Modified
225910 Modified
225908 Modified
225907 Modified
225906 Modified
225904 Modified
225903 Modified
225902 Modified
225900 Modified
225899 Modified
225898 Modified
225897 Modified
225895 Modified
225894 Modified
225893 Modified
225892 Removed
225891 Modified
225890 Modified
225889 Modified
225887 Modified
225886 Modified
225885 Modified
225884 Modified
225883 Modified
225882 Modified
225881 Modified
225880 Modified
225879 Modified
225878 Modified
225873 Modified
225871 Modified
225870 Modified
225868 Unchanged
225866 Unchanged
225861 Removed
225857 Modified
225853 Removed
225852 Removed
225850 Unchanged
225847 Unchanged
225846 Removed
225845 Unchanged
225844 Unchanged
225843 Unchanged
225841 Modified
ICR Details
0925-0753 202012-0925-003
Received in OIRA 201908-0925-003
HHS/NIH
CTEP Branch Support Contracts Forms and Surveys (NCI)
Revision of a currently approved collection   No
Regular 02/16/2021
  Requested Previously Approved
36 Months From Approved 07/31/2021
235,670 207,989
151,792 112,838
0 0

This is a revised information collection for OMB control number #0925-0753, expiration 7/31/2021 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

  85 FR 63561 10/08/2020
86 FR 9524 02/16/2021
No

70
IC Title Form No. Form Name
CPC Pharmacist's Review of Cooperative Group Study (Attachment B22) 38 CPC FB Pharma Reviewer Worksheet
Prospective Clinical Trial Survey (Attachment C10) 74 Prospective Survey
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
CTSU Roster Update Form (Attachment A5) 5 Roster Update
Site Initated Data Update Form (Attachment A8) 8 Site Data Update form
Data Clarification Form (Attachment A9) 9 Data Clarification Form
CTSU Generic Data transmittal form (Attachment A12) 12 Generic Data
CIRB Waiver of Consent Request Supplemental Form (Attachment B47) 95 CIRB WoC Supp
Review Worksheet CIRB Review for Inclusion of Incarcerated Participants (Attachment B48) 96 Attachment B48 Prisoner FB Reviewer Worksheet
Notification of Incarcerated Participant Form (Attachment B49) 97 Attachment B49 Incarcerated Participant Wrksht
Low Accural clinical Trial Survey (Attachment C11) 75 low accuring survey
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
CTSU IRB/Regulatory Approval Transmittal Form (Attachment A1) 1 IRB Transmittal
Withdrawl from Protocol Participation Form (Attachment A3) 3 Withdrawal Form
Request Waiver of Assent Form (Attachment B46) 83 Waiver Assent Worksheet
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
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
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
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 Supply Request Form (Attachment A7) 7 Supply
CTSU Transfer Form (Attachment A16) 16 Transfer
NCI CIRB Signatory Enrollment Form (Attachment B2) 19 NCI CIRB Signatory Enrollment Form
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
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 A21) 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) 1 Financial Disclosure
CTSU System Access Request Form (Attachment A17) 17 System Access Request Form
CIRB IR Application (Attachment B10) 26 CIRB IR Application
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

  Total Request 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 235,670 207,989 0 27,681 0 0
Annual Time Burden (Hours) 151,792 112,838 0 38,954 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
This revision removes several forms and surveys and adds new forms for the CIRB. The burden from the previously approved submission was 112,798 hours and with these changes, it has increased to 151,792 hours. The net change is an increase of 38,994 hours. The increase in total burden hours is driven by an increase in the number of respondents for the PMB forms (E01 – E04). From the 2018 submission, the total burden hours for PMB forms was 78,333 hours. For the current submission the total burden hours for PMB forms is 118,625. The addition of new CIRB forms increased burden for the CIRB forms by 32 hours annually, and the removal of several CTSU forms and surveys decreased the overall burden by 740 hours annually.

$1,529,246
Yes Part B of Supporting Statement
    Yes
    Yes
No
No
No
No
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.
02/16/2021


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