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) Modified 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) New 760 114 0 Form 86 Aud Maint
Audit Scheduling Form (Attachment D01) New 760 266 0 Form 84 Audit Schedule
CIRB Amendment Review Application (Attachment B12) Unchanged 400 100 0 Form and Instruction 28 CIRB AR 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) New 100 50 0 Form 82 Board member application
CIRB Board Member NDA (Attachment B6) Removed 0 0 0 Form and Instruction 22 CIRB Member NDA
CIRB Board member Annual Assessment Survey (Attachment C7) Modified 60 15 0 Form 71 CIRB Board Member Annual Assessment
CIRB Board member Biographical Sketch (Attachment B3) Removed 0 0 0 Form and Instruction 20 CIRB Biosketch Questions CIRB member
CIRB Board member Contact Information Form (Attachment B4) Removed 0 0 0 Form and Instruction 21 CIRB ContactInfoForm
CIRB COI Screening for CIRB meetings (Attachment B9) Unchanged 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) Unchanged 600 150 0 Form 65 CIRB Satisfaction survey
CIRB Direct Deposit Form (Attachment B7) Removed 0 0 0 Form 23 CIRB Direct Deposit Form
CIRB IR Application (Attachment B10) Unchanged 80 80 0 Form and Instruction 26 CIRB 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) Modified 100 25 0 Form 24 CIRB COI Update
CPC Pharmacist's Review of Cooperative Group Study (Attachment B22) Unchanged 20 40 0 Form and Instruction 38 CPC FB Pharma Reviewer Worksheet
CTSU Generic Data transmittal form (Attachment A12) Unchanged 60 10 0 Form and Instruction 12 Generic Data
CTSU Help Desk Customer Satisfaction Survey (Attachment C2) Removed 0 0 0 Form and Instruction 63 Help Desk Survey
CTSU IRB Certification Form (Attachment A2) Unchanged 29328 4888 0
CTSU IRB/Regulatory Approval Transmittal Form (Attachment A1) Unchanged 29328 978 0 Form and Instruction 1 IRB Transmittal
CTSU LPO Form Creation (Attachment A19) New 10 20 0 Form 79 Protocol Specific DTL
CTSU OPEN Rave Request Form (Attachment A18) New 630 105 0 Form 78 CTSU OPEN RaveRegForm
CTSU OPEN Survey (Attachment C3) Unchanged 60 15 0 Form 64 OPEN survey
CTSU PDF Signature Form (Attachment 21) New 4000 667 0 Form 81 Elec Sig Page
CTSU Patient Enrollment Transmittal Form (Attachment A15) Unchanged 144 24 0
CTSU Request for Clinical Brochure (Attachment A6) Unchanged 360 60 0
CTSU Roster Update Form (Attachment A5) Unchanged 600 50 0
CTSU Site Form Creation and PDF (Attachment A20) New 4000 2000 0 Form 80 Site Prot DTL
CTSU Supply Request Form (Attachment A7) Unchanged 1080 180 0
CTSU System Access Request Form (Attachment A17) Unchanged 180 60 0
CTSU Transfer Form (Attachment A16) Unchanged 720 120 0
CTSU Website Customer Satisfaction Survey (Attachment C1) Removed 0 0 0 Form 62 websurvey final
Change of SI PI Form (Attachment B45) Modified 120 40 0 Form 61 Change PI Worksheet
Concept Clinical Trial Survey (Attachment C9) Unchanged 500 42 0 Form 73 Concept Survey
Data Clarification Form (Attachment A9) Unchanged 3600 600 0 Form and Instruction 9 Data Clarification Form
ETCTN PI Survey (Attachment C12) Removed 0 0 0 Form 76 ETCTN PI Survey
ETCTN RS Survey (Attachment C13) Removed 0 0 0 Form 77 ETCTN
Final Audit Finding Report Form (Attachment D04) New 825 15098 0 Form 87 Final Audit Finding
Final Report and CAPA Request Form (Attachment D07) New 108 3240 0 Form 90 Final Report CAPA Reg.
Follow-up Form (Attachment D05) New 525 236 0 Form 88 Follow up
Follow-up survey (Communication Audit) (Attachment C5) Unchanged 300 75 0 Form 66 CIRB FUP Survey
Low Accural clinical Trial Survey (Attachment C11) Unchanged 1000 17 0 Form 75 low accuring survey
MC0845 (8233) CTSU Data Transmittal Form (Attachment A11) Removed 0 0 0 Form and Instruction 11 8233 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) New 23000 3833 0 Form and Instruction 94 Shipment Form (ASF)
NCI/DCTD/CTEP Biosketch (Attachment E02) New 33000 66000 0 Form and Instruction 92 Biosketch
NCI/DCTD/CTEP FDA Form 1572 for Annual Submission (Attachment E01) New 23000 5750 0 Form and Instruction 91 CTEP FDA Form 1572 for Annual Submission
NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03) New 33000 2750 0 Form 93 Fin Disclosure
PIO Customer Satisfaction Survey (Attachment C8) Unchanged 60 5 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 Continuing Review of Cooperative Group Protocol (Attachment B18) Removed 0 0 0 Form and Instruction 34 Oed CR 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 Expedited Strudy Chair Response to Required Mod (Attachment B30) Removed 0 0 0 Form and Instruction 46 Ped Exped Chair Resp Req Mods
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) Modified 50 100 0 Form and Instruction 37 Adult Ped FB Pharma Adult Reviewer Worksheet
Preliminary Audit Findings Form (Attachment D02) New 760 127 0 Form 85 Preliminary Audit Findings
Prospective Clinical Trial Survey (Attachment C10) Unchanged 1000 17 0 Form 74 Prospective Survey
RTOG 0834 CTSU Data Transmittal Form (Attachment A10) Unchanged 912 152 0
Request Waiver of Assent Form (Attachment B46) New 60 20 0 Form 83 Waiver Assent Worksheet
Reviewer Worksheet CPC - Determination of UP or SCN (Attachment B39) Removed 0 0 0 Form and Instruction 55 Reviewer Worksheet CPC UP FB
Reviewer Worksheet Determination of UP or SCN (Attachment B31) Modified 400 67 0 Form and Instruction 47 Reviewer Worksheet UP FB
Reviewer Worksheet expedited Review of Study Chair Response to CIRB-Required Modifications (Attachment B37) Removed 0 0 0 Form and Instruction 53 Reviewer Worksheet SCR ER
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) Modified 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) New 5 2 0 Form 89 Roster Maintenance
Site Addition Form (Attachment A4) Unchanged 960 160 0
Site Initated Data Update Form (Attachment A8) Unchanged 24 4 0 Form and Instruction 8 Site Data Update form
Study Closure or Transfer of Study Review Responsibility Form (Attachment B43) Modified 1680 560 0 Form 59 Study Closure Transfer Worksheet
Study-Specific worksheet About Local Context (Attachment B42) Unchanged 4800 1600 0 Form and Instruction 58 SSW Worksheet
TAILORx_PACCT1_Data Transmittal Form (Attachment A13) Removed 0 0 0 Form and Instruction 13 TAILORx PACCT1_DTF
UP or SCN Reporting Form (Attachment B44) Unchanged 360 120 0 Form and Instruction 60 Unanticipated Problem Worksheet
Uncolicited Data Modification Form: Protocol: TAILORx/PACCT-1 (Attachment A14) Removed 0 0 0 Form and Instruction 14 TAILORx UDM
Website Focus Groups, Communication Project (Attachments C6 A-D) Removed 0 0 0 Form 67 CIRB Website Focus Group Survey - CIRB Members usability
Form 68 CIRB Website Focus Group Survey - Local Instiutions usability
Form 69 CIRB Website Focus Group Survey - Network Groups usability
Form 70 CIRB Website Focus Group Survey -Web site usability testing
Withdrawl from Protocol Participation Form (Attachment A3) Unchanged 279 47 0
Total burden requested under this ICR: 207989 112838 0  
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