Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Adult Continuing Review of Cooperative Group Protocol (Attachment B17) Modified 275 275 0 Form and Instruction 33 Adult CR FB Reviewer Worksheet
Adult Cooperative Group Response to CIRB Review (Attachment B27) Modified 30 30 0 Form and Instruction 43 Adult & CPC FB SCRWksht
Adult Expedited Amendment Review (Attachment B23) Modified 348 174 0 Form and Instruction 39 Adult & CPC Expedited Reviewer Worksheet
Adult Expedited Continuing Review (Attachment B25) Modified 140 70 0 Form and Instruction 41 Adult & CPC Expedited CR Worksheet
Adult Expedited Study Chair Response to Required Mod (Attachment B29) Modified 40 20 0 Form 45 ER SCRwksht CIRB-ReviewRegMods
Adult IR of cooperative Group Protocol (Attachment B15) Modified 65 195 0 Form and Instruction 31 Adult IR FB Reviewer Worksheet
Adult amendment of Cooperative Group Protocol (Attachment B19) Modified 40 80 0 Form and Instruction 35 Adult AR FB Reviewer Worksheet
Annual Principal Investigator Worksheet About Local Context (Attachment B41) Modified 1800 600 0 Form and Instruction 57 Annual PI Worksheet
Annual signatory Institution Worksheet About Local Context (Attachment B40) Modified 400 267 0 Form and Instruction 56 Annual SI Worksheet
Audit Maintenance Form (Attachment D03) Modified 760 114 0 Form 86 Aud Maint
Audit Scheduling Form (Attachment D01) Unchanged 760 266 0 Form 84 Audit Schedule
CIRB Amendment Review Application (Attachment B12) Modified 400 100 0 Form and Instruction 28 CIRB AR Application
CIRB Ancillary Studies Application (Attachment B13) Modified 1 1 0 Form and Instruction 29 CIRB Ancillary Application
CIRB Application for Translated Documents (Attachment B33) Modified 100 50 0 Form and Instruction 49 CIRB App for Translated Docs
CIRB Board Member Application (Attachment B3) Modified 100 50 0 Form 82 Board member application
CIRB Board member Annual Assessment Survey (Attachment C7) Modified 60 15 0 Form 71 CIRB Board Member Annual Assessment
CIRB COI Screening for CIRB meetings (Attachment B9) Modified 72 18 0 Form and Instruction 25 COI Screening
CIRB Continuing Review Application (Attachment B14) Modified 400 100 0 Form 30 CIRB CR Application
CIRB Customer Satisfaction survey (Attachment C4) Modified 600 150 0 Form 65 CIRB Satisfaction survey
CIRB IR Application (Attachment B10) Modified 80 80 0 Form and Instruction 26 CIRB IR Application
CIRB IR Application for Exempt Studies (Attachment B11) Modified 4 2 0 Form and Instruction 27 CIRB IR Exempt Application
CIRB Member COI Screening Worksheet (Attachment B8) Modified 100 25 0 Form 24 CIRB COI Update
CIRB Waiver of Consent Request Supplemental Form (Attachment B47) New 20 5 0 Form and Instruction 95 CIRB WoC Supp
CPC Pharmacist's Review of Cooperative Group Study (Attachment B22) Removed 0 0 0 Form and Instruction 38 CPC FB Pharma Reviewer Worksheet
CTSU Generic Data transmittal form (Attachment A12) Removed 0 0 0 Form and Instruction 12 Generic Data
CTSU IRB Certification Form (Attachment A2) Unchanged 29328 4888 0 Form and Instruction 2 IRB Certification
CTSU IRB/Regulatory Approval Transmittal Form (Attachment A1) Modified 29328 978 0 Form and Instruction 1 IRB Transmittal
CTSU LPO Form Creation (Attachment A19) Unchanged 10 20 0 Form 79 Protocol Specific DTL
CTSU OPEN Rave Request Form (Attachment A18) Modified 630 105 0 Form and Instruction 76 CTSU-OPEN Rave-Form
CTSU OPEN Survey (Attachment C3) Modified 10 3 0 Form 64 OPEN survey
CTSU PDF Signature Form (Attachment A21) Modified 4000 667 0 Form 81 Elec Sig Page
CTSU Patient Enrollment Transmittal Form (Attachment A15) Unchanged 144 24 0 Form and Instruction 15 patient Enrollment Transmittal Form
CTSU Request for Clinical Brochure (Attachment A6) Unchanged 360 60 0 Form and Instruction 6 Clinical Brochure
CTSU Roster Update Form (Attachment A5) Removed 0 0 0 Form and Instruction 5 Roster Update
CTSU Site Form Creation and PDF (Attachment A20) Unchanged 4000 2000 0 Form 80 Site Prot DTL
CTSU Supply Request Form (Attachment A7) Unchanged 1080 180 0 Form and Instruction 7 Supply
CTSU System Access Request Form (Attachment A17) Modified 180 30 0 Form and Instruction 17 System Access Request Form
CTSU Transfer Form (Attachment A16) Unchanged 720 120 0 Form and Instruction 16 Transfer
Change of SI PI Form (Attachment B45) Modified 120 40 0 Form 61 Change PI Worksheet
Concept Clinical Trial Survey (Attachment C9) Removed 0 0 0 Form 73 Concept Survey
Data Clarification Form (Attachment A9) Removed 0 0 0 Form and Instruction 9 Data Clarification Form
Final Audit Finding Report Form (Attachment D04) Modified 825 15098 0 Form 87 Final Audit Finding
Final Report and CAPA Request Form (Attachment D07) Modified 108 3240 0 Form 90 Final Report CAPA Reg.
Follow-up Form (Attachment D05) Modified 525 236 0 Form 88 Follow up
Follow-up survey (Communication Audit) (Attachment C5) Modified 300 75 0 Form 66 CIRB FUP Survey
Low Accural clinical Trial Survey (Attachment C11) Removed 0 0 0 Form 75 low accuring survey
NCI CIRB AA & DOR between the NCI CIRB and Signatory Institution (Attachment B1) Modified 50 13 0 Form and Instruction 18 NCI CIRB AA DivofResps
NCI CIRB Signatory Enrollment Form (Attachment B2) Modified 50 13 0 Form and Instruction 19 NCI CIRB Signatory Enrollment Form
NCI/DCTD/CTEP Agent Shipment Form (ASF) (Attachment E04) Modified 24000 4000 0 Form and Instruction 94 Shipment Form (ASF)
NCI/DCTD/CTEP Biosketch (Attachment E02) Modified 48000 96000 0 Form and Instruction 92 Biosketch
NCI/DCTD/CTEP FDA Form 1572 for Annual Submission (Attachment E01) Modified 26500 6625 0 Form and Instruction 91 CTEP FDA Form 1572 for Annual Submission
NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03) Modified 48000 12000 0 Form 1 Financial Disclosure
Notification of Incarcerated Participant Form (Attachment B49) New 20 7 0 Form and Instruction 97 Attachment B49 Incarcerated Participant Wrksht
PIO Customer Satisfaction Survey (Attachment C8) Modified 60 5 0 Form 72 PIO External Survey
Pediatric Amendment of Cooperative Group Protocol (Attachment B20) Modified 25 50 0 Form and Instruction 36 Ped AR FB Reviewer Worksheet
Pediatric Cooperative Group Response to CIRB Review (Attachment B28) Modified 5 5 0 Form and Instruction 44 Ped FB SCRWksht
Pediatric Expedited Amendment Review (Attachment B24) Modified 140 70 0 Form and Instruction 40 Ped Expedited Reviewer Worksheet
Pediatric Expedited Continuing Review (Attachment B26) Modified 36 18 0 Form and Instruction 42 Ped Expedited CR Worksheet
Pediatric IR of Cooperative Group Protocol (Attachment B16) Modified 15 45 0 Form and Instruction 32 Ped IR FB Reviewerworksheet
Pharmacist's Review of a Cooperative Group Study (Attachment B21) Modified 50 100 0 Form and Instruction 37 Adult Ped FB Pharma Adult Reviewer Worksheet
Preliminary Audit Findings Form (Attachment D02) Modified 760 127 0 Form 85 Preliminary Audit Findings
Prospective Clinical Trial Survey (Attachment C10) Removed 0 0 0 Form 74 Prospective Survey
RTOG 0834 CTSU Data Transmittal Form (Attachment A10) Modified 912 152 0 Form and Instruction 10 RTOG0834
Request Waiver of Assent Form (Attachment B46) Modified 35 12 0 Form 83 Waiver Assent Worksheet
Review Worksheet CIRB Review for Inclusion of Incarcerated Participants (Attachment B48) New 20 20 0 Form and Instruction 96 Attachment B48 Prisoner FB Reviewer Worksheet
Reviewer Worksheet Determination of UP or SCN (Attachment B31) Modified 400 67 0 Form and Instruction 47 Reviewer Worksheet UP FB
Reviewer Worksheet of Expedited IR (Attachment B38) Modified 5 3 0 Form and Instruction 54 Reviewer Worksheet ER IR
Reviewer Worksheet of Recruitment Material (Attachment B35) Modified 20 5 0 Form and Instruction 51 Reviewer Worksheet Recruitment materials
Reviewer Worksheet of Translated Documents (Attachment B34) Modified 100 25 0 Form and Instruction 50 Reviewer Worksheet Translated Docs
Reviewer worksheet CIRB Statistical Reviewer Form (Attachment B32) Modified 100 25 0 Form 48 Current CIRB Stat Reviewer Worksheet
Reviewer worksheet Expedited Study Closure Review (Attachment B36) Modified 20 5 0 Form and Instruction 52 reviewer Worksheet ER ClosureWksht
Roster Maintenance Form (Attachment D06) Modified 5 2 0 Form 89 Roster Maintenance
Site Addition Form (Attachment A4) Unchanged 960 160 0 Form and Instruction 4 Site Addition
Site Initated Data Update Form (Attachment A8) Removed 0 0 0 Form and Instruction 8 Site Data Update form
Study Closure or Transfer of Study Review Responsibility Form (Attachment B43) Modified 1680 420 0 Form 59 Study Closure Transfer Worksheet
Study-Specific worksheet About Local Context (Attachment B42) Modified 4800 1200 0 Form and Instruction 58 SSW Worksheet
UP or SCN Reporting Form (Attachment B44) Unchanged 360 120 0 Form and Instruction 60 Unanticipated Problem Worksheet
Withdrawl from Protocol Participation Form (Attachment A3) Unchanged 279 47 0 Form and Instruction 3 Withdrawal Form
Total burden requested under this ICR: 235670 151792 0  
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