Information Collection Request

CTEP Branch Support Contracts Forms and Surveys (NCI)

ICR 202402-0925-001 · OMB 0925-0753 · Received in OIRA

Forms and Documents
DocumentTypeStatusAvailability
Form 1 PIO Customer Satisfaction Survey (Attachment C08) Form New Repair queued
Form 1 Basic Study Information Form (Attachment F01) Form New Repair queued
Form 1 International Investigator Statement (Attachment E06) Form New Repair queued
Form 1 Non-IND/NON-Treatment Registration Form (E05) Form New Repair queued
Form 1 Unanticipated Problem or Serious or Continuing Noncompliance Application (Attachment B52) Form New Repair queued
Form 1 Final Video Submission Posting Form (Attachment B50) Form New Missing upstream
Form 1 International DTL Signing (Attachment A24) Form New Repair queued
Form 1 CTSU LPO Approval for Early Closure Form (Attachement A23) Form New Repair queued
Form 1 CTSU CLASS Course Setup Form (Attachment A22) Form Modified Repair queued
Form 97 Notification of Incarcerated Participant Form (Attachment B49) Form and Instruction Unchanged Repair queued
Form 96 Review Worksheet CIRB Review for Inclusion of Incarcerated Participants (Attachment B48) Form and Instruction Unchanged Repair queued
Form 95 CIRB Waiver of Consent Request Supplemental Form (Attachment B47) Form and Instruction Unchanged Repair queued
Form 94 NCI/DCTD/CTEP Agent Shipment Form (ASF) (Attachment E04) Form and Instruction Unchanged Missing upstream
Form 1 NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03) Form Unchanged Missing upstream
Form 92 NCI/DCTD/CTEP Biosketch (Attachment E02) Form and Instruction Unchanged Repair queued
Form 91 NCI/DCTD/CTEP FDA Form 1572 for Annual Submission (Attachment E01) Form and Instruction Unchanged Repair queued
Form 90 Final Report and CAPA Request Form (Attachment D07) Form Modified Repair queued
Form 89 Roster Maintenance Form (Attachment D06) Form Modified Missing upstream
Form 88 Follow-up Form (Attachment D05) Form Modified Repair queued
Form 87 Final Audit Finding Report Form (Attachment D04) Form Modified Repair queued
Form 86 Audit Maintenance Form (Attachment D03) Form Modified Repair queued
Form 85 Preliminary Audit Findings Form (Attachment D02) Form Modified Repair queued
Form 84 Audit Scheduling Form (Attachment D01) Form Modified Repair queued
Form 83 Request Waiver of Assent Form (Attachment B46) Form Unchanged Repair queued
Form 82 CIRB Board Member Application (Attachment B3) Form Unchanged Repair queued
Form 81 CTSU PDF Signature Form (Attachment A21) Form Unchanged Repair queued
Form 80 CTSU Site Form Creation and PDF (Attachment A20) Form Unchanged Missing upstream
Form 79 CTSU LPO Form Creation (Attachment A19) Form Unchanged Repair queued
Form 76 CTSU OPEN Rave Request Form (Attachment A18) Form and Instruction Unchanged Repair queued
Form 72 PIO Customer Satisfaction Survey (Attachment C8) Form Removed Repair queued
Form 71 CIRB Board member Annual Assessment Survey (Attachment C7) Form Unchanged Repair queued
Form 66 Follow-up survey (Communication Audit) (Attachment C5) Form Unchanged Repair queued
Form 65 CIRB Customer Satisfaction survey (Attachment C4) Form Unchanged Repair queued
Form 64 CTSU OPEN Survey (Attachment C3) Form Removed Repair queued
Form 61 Change of SI PI Form (Attachment B45) Form Unchanged Repair queued
Form 60 UP or SCN Reporting Form (Attachment B44) Form and Instruction Unchanged Repair queued
Form 59 Study Closure or Transfer of Study Review Responsibility Form (Attachment B43) Form Unchanged Repair queued
Form 58 Study-Specific worksheet About Local Context (Attachment B42) Form and Instruction Unchanged Repair queued
Form 57 Annual Principal Investigator Worksheet About Local Context (Attachment B41) Form and Instruction Unchanged Repair queued
Form 56 Annual signatory Institution Worksheet About Local Context (Attachment B40) Form and Instruction Unchanged Repair queued
Form 54 Reviewer Worksheet of Expedited IR (Attachment B38) Form and Instruction Unchanged Repair queued
Form 52 Reviewer worksheet Expedited Study Closure Review (Attachment B36) Form and Instruction Unchanged Repair queued
Form 51 Reviewer Worksheet of Recruitment Material (Attachment B35) Form and Instruction Unchanged Repair queued
Form 50 Reviewer Worksheet of Translated Documents (Attachment B34) Form and Instruction Unchanged Repair queued
Form 49 CIRB Application for Translated Documents (Attachment B33) Form and Instruction Unchanged Repair queued
Form 48 Reviewer worksheet CIRB Statistical Reviewer Form (Attachment B32) Form Unchanged Repair queued
Form 47 Reviewer Worksheet Determination of UP or SCN (Attachment B31) Form and Instruction Unchanged Repair queued
Form 45 Adult Expedited Study Chair Response to Required Mod (Attachment B29) Form Unchanged Repair queued
Form 44 Pediatric Cooperative Group Response to CIRB Review (Attachment B28) Form and Instruction Unchanged Repair queued
Form 43 Adult Cooperative Group Response to CIRB Review (Attachment B27) Form and Instruction Unchanged Repair queued
Form 42 Pediatric Expedited Continuing Review (Attachment B26) Form and Instruction Unchanged Repair queued
Form 41 Adult Expedited Continuing Review (Attachment B25) Form and Instruction Unchanged Missing upstream
Form 40 Pediatric Expedited Amendment Review (Attachment B24) Form and Instruction Unchanged Repair queued
Form 39 Adult Expedited Amendment Review (Attachment B23) Form and Instruction Unchanged Repair queued
Form 37 Pharmacist's Review of a Cooperative Group Study (Attachment B21) Form and Instruction Unchanged Repair queued
Form 36 Pediatric Amendment of Cooperative Group Protocol (Attachment B20) Form and Instruction Unchanged Repair queued
Form 35 Adult amendment of Cooperative Group Protocol (Attachment B19) Form and Instruction Unchanged Repair queued
Form 33 Adult Continuing Review of Cooperative Group Protocol (Attachment B17) Form and Instruction Unchanged Repair queued
Form 32 Pediatric IR of Cooperative Group Protocol (Attachment B16) Form and Instruction Unchanged Repair queued
Form 31 Adult IR of cooperative Group Protocol (Attachment B15) Form and Instruction Unchanged Repair queued
Form 30 CIRB Continuing Review Application (Attachment B14) Form Unchanged Repair queued
Form 29 CIRB Ancillary Studies Application (Attachment B13) Form and Instruction Unchanged Repair queued
Form 1 CIRB Amendment Review Application (Attachment B12) Form Modified Repair queued
Form 27 CIRB IR Application for Exempt Studies (Attachment B11) Form and Instruction Unchanged Repair queued
Form 1 CIRB IR Application (Attachment B10) Form Modified Repair queued
Form 25 CIRB COI Screening for CIRB meetings (Attachment B9) Form and Instruction Unchanged Repair queued
Form 24 CIRB Member COI Screening Worksheet (Attachment B8) Form Unchanged Repair queued
Form 19 NCI CIRB Signatory Enrollment Form (Attachment B2) Form and Instruction Unchanged Repair queued
Form 18 NCI CIRB AA & DOR between the NCI CIRB and Signatory Institution (Attachment B1) Form and Instruction Unchanged Repair queued
Form 16 CTSU Transfer Form (Attachment A16) Form and Instruction Unchanged Missing upstream
Form 15 CTSU Patient Enrollment Transmittal Form (Attachment A15) Form and Instruction Unchanged Repair queued
Form 1 RTOG 0834 CTSU Data Transmittal Form (Attachment A10) Form Modified Repair queued
Form 7 CTSU Supply Request Form (Attachment A7) Form and Instruction Unchanged Repair queued
Form 6 CTSU Request for Clinical Brochure (Attachment A6) Form and Instruction Unchanged Repair queued
Form 4 Site Addition Form (Attachment A4) Form and Instruction Unchanged Repair queued
Form 3 Withdrawl from Protocol Participation Form (Attachment A3) Form and Instruction Unchanged Repair queued
Form 2 CTSU IRB Certification Form (Attachment A2) Form and Instruction Unchanged Repair queued
Form 1 CTSU IRB/Regulatory Approval Transmittal Form (Attachment A1) Form Modified Repair queued
Attachment G10_CTEPESYS_FIPS.pdf Supplementary Document Uploaded 2024-03-27 Repair queued
Attachment G09_CTEP_PIA.pdf Supplementary Document Uploaded 2024-03-27 Repair queued
Attachment G06 - CIRB - Emmes IRB_exempt.pdf Supplementary Document Uploaded 2024-03-27 Repair queued
Attachment G05 - CIRB - OHSR Determination.pdf Supplementary Document Uploaded 2024-03-27 Repair queued
Attachment G04 - CTEP_ESYS FIPS 199 System Categorization _FY2023 V 1.0 Final.pdf Supplementary Document Uploaded 2024-03-27 Repair queued
Attachment G03 - Privacy Act Memo.pdf Supplementary Document Uploaded 2024-03-27 Missing upstream
Attachment G02_IRB and OHSR determination.pdf Supplementary Document Uploaded 2024-03-27 Repair queued
Attachment G01 - PIA - Cancer Therapy Evaluation System 9-6-2022 Approved.pdf Supplementary Document Uploaded 2024-03-27 Repair queued
SSB_CTEP 3.13.2024 FINAL.docx Supporting Statement B Uploaded 2024-03-27 Repair queued
SSA_CTEP REV 3.13.2024 FINAL.docx Supporting Statement A Uploaded 2024-03-27 Repair queued
CTEP 30day FRN.pdf Supplementary Document Uploaded 2024-03-27 Missing upstream
Changes in Attach-ments as of 2.14.2024 - for OMB.xlsx Supplementary Document Uploaded 2024-03-13 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
266102 PIO Customer Satisfaction Survey (Attachment C08) Form New
265729 Basic Study Information Form (Attachment F01) Form New
265728 International Investigator Statement (Attachment E06) Form New
265725 Non-IND/NON-Treatment Registration Form (E05) Form New
265724 Unanticipated Problem or Serious or Continuing Noncompliance Application (Attachment B52) Form New
265723 Final Video Submission Posting Form (Attachment B50) Form New
265722 International DTL Signing (Attachment A24) Form New
265721 CTSU LPO Approval for Early Closure Form (Attachement A23) Form New
255631 CTSU CLASS Course Setup Form (Attachment A22) Form Modified
245475 Notification of Incarcerated Participant Form (Attachment B49) Form and Instruction Unchanged
245474 Review Worksheet CIRB Review for Inclusion of Incarcerated Participants (Attachment B48) Form and Instruction Unchanged
245472 CIRB Waiver of Consent Request Supplemental Form (Attachment B47) Form and Instruction Unchanged
230005 NCI/DCTD/CTEP Agent Shipment Form (ASF) (Attachment E04) Form and Instruction Unchanged
230004 NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03) Form Unchanged
230003 NCI/DCTD/CTEP Biosketch (Attachment E02) Form and Instruction Unchanged
230002 NCI/DCTD/CTEP FDA Form 1572 for Annual Submission (Attachment E01) Form and Instruction Unchanged
230001 Final Report and CAPA Request Form (Attachment D07) Form Modified
230000 Roster Maintenance Form (Attachment D06) Form Modified
229999 Follow-up Form (Attachment D05) Form Modified
229998 Final Audit Finding Report Form (Attachment D04) Form Modified
229997 Audit Maintenance Form (Attachment D03) Form Modified
229995 Preliminary Audit Findings Form (Attachment D02) Form Modified
229993 Audit Scheduling Form (Attachment D01) Form Modified
229991 Request Waiver of Assent Form (Attachment B46) Form Unchanged
229989 CIRB Board Member Application (Attachment B3) Form Unchanged
229988 CTSU PDF Signature Form (Attachment A21) Form Unchanged
229986 CTSU Site Form Creation and PDF (Attachment A20) Form Unchanged
229985 CTSU LPO Form Creation (Attachment A19) Form Unchanged
229984 CTSU OPEN Rave Request Form (Attachment A18) Form and Instruction Unchanged
225926 PIO Customer Satisfaction Survey (Attachment C8) Form Removed
225925 CIRB Board member Annual Assessment Survey (Attachment C7) Form Unchanged
225923 Follow-up survey (Communication Audit) (Attachment C5) Form Unchanged
225922 CIRB Customer Satisfaction survey (Attachment C4) Form Unchanged
225921 CTSU OPEN Survey (Attachment C3) Form Removed
225917 Change of SI PI Form (Attachment B45) Form Unchanged
225916 UP or SCN Reporting Form (Attachment B44) Form and Instruction Unchanged
225915 Study Closure or Transfer of Study Review Responsibility Form (Attachment B43) Form Unchanged
225914 Study-Specific worksheet About Local Context (Attachment B42) Form and Instruction Unchanged
225913 Annual Principal Investigator Worksheet About Local Context (Attachment B41) Form and Instruction Unchanged
225912 Annual signatory Institution Worksheet About Local Context (Attachment B40) Form and Instruction Unchanged
225910 Reviewer Worksheet of Expedited IR (Attachment B38) Form and Instruction Unchanged
225908 Reviewer worksheet Expedited Study Closure Review (Attachment B36) Form and Instruction Unchanged
225907 Reviewer Worksheet of Recruitment Material (Attachment B35) Form and Instruction Unchanged
225906 Reviewer Worksheet of Translated Documents (Attachment B34) Form and Instruction Unchanged
225904 CIRB Application for Translated Documents (Attachment B33) Form and Instruction Unchanged
225903 Reviewer worksheet CIRB Statistical Reviewer Form (Attachment B32) Form Unchanged
225902 Reviewer Worksheet Determination of UP or SCN (Attachment B31) Form and Instruction Unchanged
225900 Adult Expedited Study Chair Response to Required Mod (Attachment B29) Form Unchanged
225899 Pediatric Cooperative Group Response to CIRB Review (Attachment B28) Form and Instruction Unchanged
225898 Adult Cooperative Group Response to CIRB Review (Attachment B27) Form and Instruction Unchanged
225897 Pediatric Expedited Continuing Review (Attachment B26) Form and Instruction Unchanged
225895 Adult Expedited Continuing Review (Attachment B25) Form and Instruction Unchanged
225894 Pediatric Expedited Amendment Review (Attachment B24) Form and Instruction Unchanged
225893 Adult Expedited Amendment Review (Attachment B23) Form and Instruction Unchanged
225891 Pharmacist's Review of a Cooperative Group Study (Attachment B21) Form and Instruction Unchanged
225890 Pediatric Amendment of Cooperative Group Protocol (Attachment B20) Form and Instruction Unchanged
225889 Adult amendment of Cooperative Group Protocol (Attachment B19) Form and Instruction Unchanged
225887 Adult Continuing Review of Cooperative Group Protocol (Attachment B17) Form and Instruction Unchanged
225886 Pediatric IR of Cooperative Group Protocol (Attachment B16) Form and Instruction Unchanged
225885 Adult IR of cooperative Group Protocol (Attachment B15) Form and Instruction Unchanged
225884 CIRB Continuing Review Application (Attachment B14) Form Unchanged
225883 CIRB Ancillary Studies Application (Attachment B13) Form and Instruction Unchanged
225882 CIRB Amendment Review Application (Attachment B12) Form Modified
225881 CIRB IR Application for Exempt Studies (Attachment B11) Form and Instruction Unchanged
225880 CIRB IR Application (Attachment B10) Form Modified
225879 CIRB COI Screening for CIRB meetings (Attachment B9) Form and Instruction Unchanged
225878 CIRB Member COI Screening Worksheet (Attachment B8) Form Unchanged
225873 NCI CIRB Signatory Enrollment Form (Attachment B2) Form and Instruction Unchanged
225871 NCI CIRB AA & DOR between the NCI CIRB and Signatory Institution (Attachment B1) Form and Instruction Unchanged
225868 CTSU Transfer Form (Attachment A16) Form and Instruction Unchanged
225866 CTSU Patient Enrollment Transmittal Form (Attachment A15) Form and Instruction Unchanged
225857 RTOG 0834 CTSU Data Transmittal Form (Attachment A10) Form Modified
225850 CTSU Supply Request Form (Attachment A7) Form and Instruction Unchanged
225847 CTSU Request for Clinical Brochure (Attachment A6) Form and Instruction Unchanged
225845 Site Addition Form (Attachment A4) Form and Instruction Unchanged
225844 Withdrawl from Protocol Participation Form (Attachment A3) Form and Instruction Unchanged
225843 CTSU IRB Certification Form (Attachment A2) Form and Instruction Unchanged
225841 CTSU IRB/Regulatory Approval Transmittal Form (Attachment A1) Form Modified
ICR Details
StatusReceived in OIRA
Agency/SubagencyHHS/NIH
OMB Control No0925-0753
Type of Information CollectionRevision of a currently approved collection
Previous ICR Reference No202307-0925-003
Date Submitted to OIRA1969-12-31
Requested Expiration Date1969-12-31