CTEP Branch Support Contracts Forms and Surveys (NCI)

OMB 0925-0753

This is a revised information collection for OMB control number #0925-0753, expiration 6/30/2020 for three years. The National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) and the Division of Cancer Prevention (DCP) fund an extensive national program of cancer research, sponsoring clinical trials in cancer prevention, symptom management and treatment for qualified clinical investigators. As part of this effort, CTEP implements programs to register clinical site investigators and clinical site staff, and to oversee the conduct of research at the clinical sites. CTEP and DCP also oversee two support programs, the NCI Central Institutional Review Board (CIRB) and the Cancer Trial Support Unit (CTSU). The combined systems and processes for initiating and managing clinical trials is termed the Clinical Oncology Research Enterprise (CORE) and represents an integrated set of information systems and processes which support investigator registration, trial oversight, patient enrollment, and clinical data collection. The information collected is required to ensure compliance with applicable federal regulations governing the conduct of human subjects research (45 CFR 46 and 21 CRF 50), and when CTEP acts as the Investigational New Drug (IND) holder (FDA regulations pertaining to the sponsor of clinical trials and the selection of qualified investigators under 21 CRF 312.53).

The latest form for CTEP Branch Support Contracts Forms and Surveys (NCI) expires 2021-07-31 and can be found here.

Latest Forms, Documents, and Supporting Material

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

All Historical Document Collections

202402-0925-001	Revision of a currently approved collection	2024-03-28
202307-0925-003 Approved without change	No material or nonsubstantive change to a currently approved collection	2023-07-14
202208-0925-003 Approved without change	Revision of a currently approved collection	2022-09-07
202111-0925-002 Approved without change	No material or nonsubstantive change to a currently approved collection	2021-11-10
202012-0925-003 Approved without change	Revision of a currently approved collection	2021-02-16
201908-0925-003 Approved without change	No material or nonsubstantive change to a currently approved collection	2019-08-15
201906-0925-003 Approved without change	No material or nonsubstantive change to a currently approved collection	2019-07-02
201809-0925-002 Approved without change	No material or nonsubstantive change to a currently approved collection	2018-09-25
201802-0925-001 Approved without change	Revision of a currently approved collection	2018-05-01
201702-0925-003 Approved with change	New collection (Request for a new OMB Control Number)	2017-03-07

OMB Details

CTSU IRB/Regulatory Approval Transmittal Form (Attachment A1)

Federal Enterprise Architecture: Health - Public Health Monitoring

Form 1

IRB Transmittal

Fillable Fileable

Form and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.