CTEP Branch Support Contracts Forms and Surveys (NCI)

ICR 202402-0925-001

OMB: 0925-0753

Federal Form Document

⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0925-0753 can be found here:

2024-11-12 - No material or nonsubstantive change to a currently approved collection
2024-08-29 - No material or nonsubstantive change to a currently approved collection

Forms and Documents

Document Name	Status
Form 1 PIO Customer Satisfaction Survey (Attachment C08) Form	New
Form 1 Basic Study Information Form (Attachment F01) Form	New
Form 1 International Investigator Statement (Attachment E06) Form	New
Form 1 Non-IND/NON-Treatment Registration Form (E05) Form	New
Form 1 Unanticipated Problem or Serious or Continuing Noncompliance Application (Attachment B52) Form	New
Form 1 Final Video Submission Posting Form (Attachment B50) Form	New
Form 1 International DTL Signing (Attachment A24) Form	New
Form 1 CTSU LPO Approval for Early Closure Form (Attachement A23) Form	New
Form 1 CTSU CLASS Course Setup Form (Attachment A22) Form	Modified
Form 97 Notification of Incarcerated Participant Form (Attachment B49) Form and Instruction	Unchanged
Form 96 Review Worksheet CIRB Review for Inclusion of Incarcerated Participants (Attachment B48) Form and Instruction	Unchanged
Form 95 CIRB Waiver of Consent Request Supplemental Form (Attachment B47) Form and Instruction	Unchanged
Form 94 NCI/DCTD/CTEP Agent Shipment Form (ASF) (Attachment E04) Form and Instruction	Unchanged
Form 1 NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03) Form	Unchanged
Form 92 NCI/DCTD/CTEP Biosketch (Attachment E02) Form and Instruction	Unchanged
Form 91 NCI/DCTD/CTEP FDA Form 1572 for Annual Submission (Attachment E01) Form and Instruction	Unchanged
Form 90 Final Report and CAPA Request Form (Attachment D07) Form	Modified
Form 89 Roster Maintenance Form (Attachment D06) Form	Modified
Form 88 Follow-up Form (Attachment D05) Form	Modified
Form 87 Final Audit Finding Report Form (Attachment D04) Form	Modified
Form 86 Audit Maintenance Form (Attachment D03) Form	Modified
Form 85 Preliminary Audit Findings Form (Attachment D02) Form	Modified
Form 84 Audit Scheduling Form (Attachment D01) Form	Modified
Form 83 Request Waiver of Assent Form (Attachment B46) Form	Unchanged
Form 82 CIRB Board Member Application (Attachment B3) Form	Unchanged
Form 81 CTSU PDF Signature Form (Attachment A21) Form	Unchanged
Form 80 CTSU Site Form Creation and PDF (Attachment A20) Form	Unchanged
Form 79 CTSU LPO Form Creation (Attachment A19) Form	Unchanged
Form 76 CTSU OPEN Rave Request Form (Attachment A18) Form and Instruction	Unchanged
Form 72 PIO Customer Satisfaction Survey (Attachment C8) Form	Removed
Form 71 CIRB Board member Annual Assessment Survey (Attachment C7) Form	Unchanged
Form 66 Follow-up survey (Communication Audit) (Attachment C5) Form	Unchanged
Form 65 CIRB Customer Satisfaction survey (Attachment C4) Form	Unchanged
Form 64 CTSU OPEN Survey (Attachment C3) Form	Removed
Form 61 Change of SI PI Form (Attachment B45) Form	Unchanged
Form 60 UP or SCN Reporting Form (Attachment B44) Form and Instruction	Unchanged
Form 59 Study Closure or Transfer of Study Review Responsibility Form (Attachment B43) Form	Unchanged
Form 58 Study-Specific worksheet About Local Context (Attachment B42) Form and Instruction	Unchanged
Form 57 Annual Principal Investigator Worksheet About Local Context (Attachment B41) Form and Instruction	Unchanged
Form 56 Annual signatory Institution Worksheet About Local Context (Attachment B40) Form and Instruction	Unchanged
Form 54 Reviewer Worksheet of Expedited IR (Attachment B38) Form and Instruction	Unchanged
Form 52 Reviewer worksheet Expedited Study Closure Review (Attachment B36) Form and Instruction	Unchanged
Form 51 Reviewer Worksheet of Recruitment Material (Attachment B35) Form and Instruction	Unchanged
Form 50 Reviewer Worksheet of Translated Documents (Attachment B34) Form and Instruction	Unchanged
Form 49 CIRB Application for Translated Documents (Attachment B33) Form and Instruction	Unchanged
Form 48 Reviewer worksheet CIRB Statistical Reviewer Form (Attachment B32) Form	Unchanged
Form 47 Reviewer Worksheet Determination of UP or SCN (Attachment B31) Form and Instruction	Unchanged
Form 45 Adult Expedited Study Chair Response to Required Mod (Attachment B29) Form	Unchanged
Form 44 Pediatric Cooperative Group Response to CIRB Review (Attachment B28) Form and Instruction	Unchanged
Form 43 Adult Cooperative Group Response to CIRB Review (Attachment B27) Form and Instruction	Unchanged
Form 42 Pediatric Expedited Continuing Review (Attachment B26) Form and Instruction	Unchanged
Form 41 Adult Expedited Continuing Review (Attachment B25) Form and Instruction	Unchanged
Form 40 Pediatric Expedited Amendment Review (Attachment B24) Form and Instruction	Unchanged
Form 39 Adult Expedited Amendment Review (Attachment B23) Form and Instruction	Unchanged
Form 37 Pharmacist's Review of a Cooperative Group Study (Attachment B21) Form and Instruction	Unchanged
Form 36 Pediatric Amendment of Cooperative Group Protocol (Attachment B20) Form and Instruction	Unchanged
Form 35 Adult amendment of Cooperative Group Protocol (Attachment B19) Form and Instruction	Unchanged
Form 33 Adult Continuing Review of Cooperative Group Protocol (Attachment B17) Form and Instruction	Unchanged
Form 32 Pediatric IR of Cooperative Group Protocol (Attachment B16) Form and Instruction	Unchanged
Form 31 Adult IR of cooperative Group Protocol (Attachment B15) Form and Instruction	Unchanged
Form 30 CIRB Continuing Review Application (Attachment B14) Form	Unchanged
Form 29 CIRB Ancillary Studies Application (Attachment B13) Form and Instruction	Unchanged
Form 1 CIRB Amendment Review Application (Attachment B12) Form	Modified
Form 27 CIRB IR Application for Exempt Studies (Attachment B11) Form and Instruction	Unchanged
Form 1 CIRB IR Application (Attachment B10) Form	Modified
Form 25 CIRB COI Screening for CIRB meetings (Attachment B9) Form and Instruction	Unchanged
Form 24 CIRB Member COI Screening Worksheet (Attachment B8) Form	Unchanged
Form 19 NCI CIRB Signatory Enrollment Form (Attachment B2) Form and Instruction	Unchanged
Form 18 NCI CIRB AA & DOR between the NCI CIRB and Signatory Institution (Attachment B1) Form and Instruction	Unchanged
Form 16 CTSU Transfer Form (Attachment A16) Form and Instruction	Unchanged
Form 15 CTSU Patient Enrollment Transmittal Form (Attachment A15) Form and Instruction	Unchanged
Form 1 RTOG 0834 CTSU Data Transmittal Form (Attachment A10) Form	Modified
Form 7 CTSU Supply Request Form (Attachment A7) Form and Instruction	Unchanged
Form 6 CTSU Request for Clinical Brochure (Attachment A6) Form and Instruction	Unchanged
Form 4 Site Addition Form (Attachment A4) Form and Instruction	Unchanged
Form 3 Withdrawl from Protocol Participation Form (Attachment A3) Form and Instruction	Unchanged
Form 2 CTSU IRB Certification Form (Attachment A2) Form and Instruction	Unchanged
Form 1 CTSU IRB/Regulatory Approval Transmittal Form (Attachment A1) Form	Modified
Attachment G10_CTEPESYS_FIPS.pdf Supplementary Document	2024-03-27
Attachment G09_CTEP_PIA.pdf Supplementary Document	2024-03-27
Attachment G06 - CIRB - Emmes IRB_exempt.pdf Supplementary Document	2024-03-27
Attachment G05 - CIRB - OHSR Determination.pdf Supplementary Document	2024-03-27
Attachment G04 - CTEP_ESYS FIPS 199 System Categorization _FY2023 V 1.0 Final.pdf Supplementary Document	2024-03-27
Attachment G03 - Privacy Act Memo.pdf Supplementary Document	2024-03-27
Attachment G02_IRB and OHSR determination.pdf Supplementary Document	2024-03-27
Attachment G01 - PIA - Cancer Therapy Evaluation System 9-6-2022 Approved.pdf Supplementary Document	2024-03-27
SSB_CTEP 3.13.2024 FINAL.docx Supporting Statement B	2024-03-27
SSA_CTEP REV 3.13.2024 FINAL.docx Supporting Statement A	2024-03-27
CTEP 30day FRN.pdf Supplementary Document	2024-03-27
Changes in Attach-ments as of 2.14.2024 - for OMB.xlsx Supplementary Document	2024-03-13

IC Document Collections

IC ID	Document Title	Status
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