Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Adult Continuing Review of Cooperative Group Protocol (Attachment B17) Unchanged 275 275 0 Form and Instruction 33 Adult CR FB Reviewer Worksheet
Adult Cooperative Group Response to CIRB Review (Attachment B27) Unchanged 30 30 0 Form and Instruction 43 Adult & CPC FB SCRWksht
Adult Expedited Amendment Review (Attachment B23) Unchanged 348 174 0 Form and Instruction 39 Adult & CPC Expedited Reviewer Worksheet
Adult Expedited Continuing Review (Attachment B25) Unchanged 140 70 0 Form and Instruction 41 Adult & CPC Expedited CR Worksheet
Adult Expedited Study Chair Response to Required Mod (Attachment B29) Unchanged 40 20 0 Form 45 ER SCRwksht CIRB-ReviewRegMods
Adult IR of cooperative Group Protocol (Attachment B15) Unchanged 65 195 0 Form and Instruction 31 Adult IR FB Reviewer Worksheet
Adult amendment of Cooperative Group Protocol (Attachment B19) Unchanged 40 80 0 Form and Instruction 35 Adult AR FB Reviewer Worksheet
Annual Principal Investigator Worksheet About Local Context (Attachment B41) Unchanged 1800 600 0 Form and Instruction 57 Annual PI Worksheet
Annual signatory Institution Worksheet About Local Context (Attachment B40) Unchanged 400 267 0 Form and Instruction 56 Annual SI Worksheet
Audit Maintenance Form (Attachment D03) Modified 790 119 0 Form 86 Aud Maint
Audit Scheduling Form (Attachment D01) Modified 1145 401 0 Form 84 Audit Schedule
Basic Study Information Form (Attachment F01) New 140 47 0 Form 1 Registration
CIRB Amendment Review Application (Attachment B12) Modified 400 100 0 Form 1 Application
CIRB Ancillary Studies Application (Attachment B13) Unchanged 1 1 0 Form and Instruction 29 CIRB Ancillary Application
CIRB Application for Translated Documents (Attachment B33) Unchanged 100 50 0 Form and Instruction 49 CIRB App for Translated Docs
CIRB Board Member Application (Attachment B3) Unchanged 100 50 0 Form 82 Board member application
CIRB Board member Annual Assessment Survey (Attachment C7) Unchanged 60 15 0 Form 71 CIRB Board Member Annual Assessment
CIRB COI Screening for CIRB meetings (Attachment B9) Unchanged 72 18 0 Form and Instruction 25 COI Screening
CIRB Continuing Review Application (Attachment B14) Unchanged 400 100 0 Form 30 CIRB CR Application
CIRB Customer Satisfaction survey (Attachment C4) Unchanged 600 150 0 Form 65 CIRB Satisfaction survey
CIRB IR Application (Attachment B10) Modified 80 80 0 Form 1 IR Application
CIRB IR Application for Exempt Studies (Attachment B11) Unchanged 4 2 0 Form and Instruction 27 CIRB IR Exempt Application
CIRB Member COI Screening Worksheet (Attachment B8) Unchanged 100 25 0 Form 24 CIRB COI Update
CIRB Waiver of Consent Request Supplemental Form (Attachment B47) Unchanged 20 5 0 Form and Instruction 95 CIRB WoC Supp
CTSU CLASS Course Setup Form (Attachment A22) Modified 20 7 0 Form 1 Class Request Form
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 1 Transmittal Form
CTSU LPO Approval for Early Closure Form (Attachement A23) New 14664 4888 0 Form 1 Early Closure Form
CTSU LPO Form Creation (Attachment A19) Unchanged 10 20 0 Form 79 Protocol Specific DTL
CTSU OPEN Rave Request Form (Attachment A18) Unchanged 630 105 0 Form and Instruction 76 CTSU OPEN Rave Request
CTSU OPEN Survey (Attachment C3) Removed 0 0 0 Form 64 OPEN survey
CTSU PDF Signature Form (Attachment A21) Unchanged 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 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 Transfer Form (Attachment A16) Unchanged 720 120 0 Form and Instruction 16 Transfer
Change of SI PI Form (Attachment B45) Unchanged 120 40 0 Form 61 Change PI Worksheet
Final Audit Finding Report Form (Attachment D04) Modified 1210 22143 0 Form 87 Final Audit Finding
Final Report and CAPA Request Form (Attachment D07) Modified 27 810 0 Form 90 Final Report CAPA Reg.
Final Video Submission Posting Form (Attachment B50) New 80 20 0 Form 1 CIRB Final Video Submission
Follow-up Form (Attachment D05) Modified 308 139 0 Form 88 Follow up
Follow-up survey (Communication Audit) (Attachment C5) Unchanged 300 75 0 Form 66 CIRB FUP Survey
International DTL Signing (Attachment A24) New 29 5 0 Form 1 International DTL Signing
International Investigator Statement (Attachment E06) New 2100 525 0 Form 1 International Investigator Statement (IIS) Form
NCI CIRB AA & DOR between the NCI CIRB and Signatory Institution (Attachment B1) Unchanged 50 13 0 Form and Instruction 18 NCI CIRB AA DivofResps
NCI CIRB Signatory Enrollment Form (Attachment B2) Unchanged 50 13 0 Form and Instruction 19 NCI CIRB Signatory Enrollment Form
NCI/DCTD/CTEP Agent Shipment Form (ASF) (Attachment E04) Unchanged 24000 4000 0 Form and Instruction 94 Shipment Form (ASF)
NCI/DCTD/CTEP Biosketch (Attachment E02) Unchanged 48000 96000 0 Form and Instruction 92 Biosketch
NCI/DCTD/CTEP FDA Form 1572 for Annual Submission (Attachment E01) Unchanged 26500 6625 0 Form and Instruction 91 CTEP FDA Form 1572 for Annual Submission
NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03) Unchanged 48000 12000 0 Form 1 Financial Disclosure
Non-IND/NON-Treatment Registration Form (E05) New 1000 1000 0 Form 1 Non-IND/Non-Treatment Registration Form
Notification of Incarcerated Participant Form (Attachment B49) Unchanged 20 7 0 Form and Instruction 97 Attachment B49 Incarcerated Participant Wrksht
PIO Customer Satisfaction Survey (Attachment C08) New 60 5 0 Form 1 PIO External Survey
PIO Customer Satisfaction Survey (Attachment C8) Removed 0 0 0 Form 72 PIO External Survey
Pediatric Amendment of Cooperative Group Protocol (Attachment B20) Unchanged 25 50 0 Form and Instruction 36 Ped AR FB Reviewer Worksheet
Pediatric Cooperative Group Response to CIRB Review (Attachment B28) Unchanged 5 5 0 Form and Instruction 44 Ped FB SCRWksht
Pediatric Expedited Amendment Review (Attachment B24) Unchanged 140 70 0 Form and Instruction 40 Ped Expedited Reviewer Worksheet
Pediatric Expedited Continuing Review (Attachment B26) Unchanged 36 18 0 Form and Instruction 42 Ped Expedited CR Worksheet
Pediatric IR of Cooperative Group Protocol (Attachment B16) Unchanged 15 45 0 Form and Instruction 32 Ped IR FB Reviewerworksheet
Pharmacist's Review of a Cooperative Group Study (Attachment B21) Unchanged 50 100 0 Form and Instruction 37 Adult Ped FB Pharma Adult Reviewer Worksheet
Preliminary Audit Findings Form (Attachment D02) Modified 1145 191 0 Form 85 Preliminary Audit Findings
RTOG 0834 CTSU Data Transmittal Form (Attachment A10) Modified 60 5 0 Form 1 RTOG 0834 CTSU Data Transmittal Form
Request Waiver of Assent Form (Attachment B46) Unchanged 35 12 0 Form 83 Waiver Assent Worksheet
Review Worksheet CIRB Review for Inclusion of Incarcerated Participants (Attachment B48) Unchanged 20 20 0 Form and Instruction 96 Attachment B48 Prisoner FB Reviewer Worksheet
Reviewer Worksheet Determination of UP or SCN (Attachment B31) Unchanged 400 67 0 Form and Instruction 47 Reviewer Worksheet UP FB
Reviewer Worksheet of Expedited IR (Attachment B38) Unchanged 5 3 0 Form and Instruction 54 Reviewer Worksheet ER IR
Reviewer Worksheet of Recruitment Material (Attachment B35) Unchanged 20 5 0 Form and Instruction 51 Reviewer Worksheet Recruitment materials
Reviewer Worksheet of Translated Documents (Attachment B34) Unchanged 100 25 0 Form and Instruction 50 Reviewer Worksheet Translated Docs
Reviewer worksheet CIRB Statistical Reviewer Form (Attachment B32) Unchanged 100 25 0 Form 48 Current CIRB Stat Reviewer Worksheet
Reviewer worksheet Expedited Study Closure Review (Attachment B36) Unchanged 20 5 0 Form and Instruction 52 reviewer Worksheet ER ClosureWksht
Roster Maintenance Form (Attachment D06) Modified 7 2 0 Form 89 Roster Maintenance
Site Addition Form (Attachment A4) Unchanged 960 160 0 Form and Instruction 4 Site Addition
Study Closure or Transfer of Study Review Responsibility Form (Attachment B43) Unchanged 1680 420 0 Form 59 Study Closure Transfer Worksheet
Study-Specific worksheet About Local Context (Attachment B42) Unchanged 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
Unanticipated Problem or Serious or Continuing Noncompliance Application (Attachment B52) New 20 10 0 Form 1 Unanticipated Problem or Serious or Continuing Noncompliance Application
Withdrawl from Protocol Participation Form (Attachment A3) Unchanged 279 47 0 Form and Instruction 3 Withdrawal Form
Total burden requested under this ICR: 253570 162836 0  
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