CTEP Branch Support Contracts Forms and Surveys (NCI)

ICR 201802-0925-001

OMB: 0925-0753

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
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New
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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
IC ID
Document
Title
Status
230005 New
230004 New
230003 New
230002 New
230001 New
230000 New
229999 New
229998 New
229997 New
229995 New
229993 New
229991 New
229989 New
229988 New
229986 New
229985 New
229984 New
225931 Removed
225930 Removed
225929 Unchanged
225928 Unchanged
225927 Unchanged
225926 Unchanged
225925 Modified
225924 Removed
225923 Unchanged
225922 Unchanged
225921 Unchanged
225919 Removed
225918 Removed
225917 Modified
225916 Unchanged
225915 Modified
225914 Unchanged
225913 Unchanged
225912 Unchanged
225911 Removed
225910 Unchanged
225909 Removed
225908 Unchanged
225907 Unchanged
225906 Unchanged
225904 Unchanged
225903 Modified
225902 Modified
225901 Removed
225900 Modified
225899 Unchanged
225898 Unchanged
225897 Unchanged
225895 Unchanged
225894 Unchanged
225893 Unchanged
225892 Unchanged
225891 Modified
225890 Unchanged
225889 Unchanged
225888 Removed
225887 Unchanged
225886 Unchanged
225885 Unchanged
225884 Modified
225883 Unchanged
225882 Unchanged
225881 Unchanged
225880 Unchanged
225879 Unchanged
225878 Modified
225877 Removed
225876 Removed
225875 Removed
225874 Removed
225873 Unchanged
225871 Unchanged
225870
Unchanged
225868
Unchanged
225866
Unchanged
225863 Removed
225862 Removed
225861 Unchanged
225860 Removed
225857
Unchanged
225853 Unchanged
225852 Unchanged
225850
Unchanged
225847
Unchanged
225846
Unchanged
225845
Unchanged
225844
Unchanged
225843
Unchanged
225841 Unchanged
ICR Details
0925-0753 201802-0925-001
Historical Active 201702-0925-003
HHS/NIH
CTEP Branch Support Contracts Forms and Surveys (NCI)
Revision of a currently approved collection   No
Regular
Approved without change 07/31/2018
Retrieve Notice of Action (NOA) 05/01/2018
  Inventory as of this Action Requested Previously Approved
07/31/2021 36 Months From Approved 06/30/2020
207,989 0 100,337
112,838 0 15,524
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
CTSU Request for Clinical Brochure (Attachment A6) 6
CTSU Supply Request Form (Attachment A7) 7
CTSU Transfer Form (Attachment A16) 16
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
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
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
CTSU Help Desk Customer Satisfaction Survey (Attachment C2) 63 Help Desk Survey
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
ETCTN PI Survey (Attachment C12) 76 ETCTN PI Survey
NCI/DCTD/CTEP FDA Form 1572 for Annual Submission (Attachment E01) 91 CTEP FDA Form 1572 for Annual Submission
TAILORx_PACCT1_Data Transmittal Form (Attachment A13) 13 TAILORx PACCT1_DTF
MC0845 (8233) CTSU Data Transmittal Form (Attachment A11) 11 8233 Form
Uncolicited Data Modification Form: Protocol: TAILORx/PACCT-1 (Attachment A14) 14 TAILORx UDM
CTSU OPEN Rave Request Form (Attachment A18) 78 CTSU OPEN RaveRegForm
CIRB Board member Biographical Sketch (Attachment B3) 20 CIRB Biosketch Questions CIRB member
CIRB Direct Deposit Form (Attachment B7) 23 CIRB Direct Deposit Form
ETCTN RS Survey (Attachment C13) 77 ETCTN
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
CIRB Board Member NDA (Attachment B6) 22 CIRB Member NDA
Pediatric Expedited Strudy Chair Response to Required Mod (Attachment B30) 46 Ped Exped Chair Resp Req Mods
Reviewer Worksheet CPC - Determination of UP or SCN (Attachment B39) 55 Reviewer Worksheet CPC UP FB
CTSU Website Customer Satisfaction Survey (Attachment C1) 62 websurvey final
Adult Expedited Study Chair Response to Required Mod (Attachment B29) 45 ER SCRwksht CIRB-ReviewRegMods
RTOG 0834 CTSU Data Transmittal Form (Attachment A10) 10
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 Fin Disclosure
CIRB Board member Contact Information Form (Attachment B4) 21 CIRB ContactInfoForm
Pediatric Continuing Review of Cooperative Group Protocol (Attachment B18) 34 Oed CR FB Reviewer Worksheet
CTSU Generic Data transmittal form (Attachment A12) 12 Generic Data
CTSU System Access Request Form (Attachment A17) 17
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
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
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
Site Addition Form (Attachment A4) 4
CTSU IRB/Regulatory Approval Transmittal Form (Attachment A1) 1 IRB Transmittal
Withdrawl from Protocol Participation Form (Attachment A3) 3
Site Initated Data Update Form (Attachment A8) 8 Site Data Update form
Reviewer Worksheet expedited Review of Study Chair Response to CIRB-Required Modifications (Attachment B37) 53 Reviewer Worksheet SCR ER
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
CTSU Patient Enrollment Transmittal Form (Attachment A15) 15
CTSU Roster Update Form (Attachment A5) 5

  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 207,989 100,337 0 107,652 0 0
Annual Time Burden (Hours) 112,838 15,524 0 97,314 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
This revision adds data collection for the CTMB AIS and for the PMB RCR as well as form changes for the CTSU and CIRB. The burden from the previously approved submission was 15,524 and with these changes it has increased to 112,838. The net change is an increase of 97,314 hours. The CTMB AIS forms accounts for an additional 19,082 hours, and the PMB RCR forms for an additional 78,333 hours. The burden hours for the CTSU, CIRB and surveys slightly decreased to 15,524 hours.

$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.
05/01/2018


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