Office of Clinical Research (OCR)

National Cancer Institute Central IRB (NCI CIRB)

If you are utilizing an external IRB for the first time, contact the OCR staff prior to submitting (210-567-8555 or OCRMail@uthscsa.edu).

 

The Central Institutional Review Board (CIRB) Initiative is sponsored by the National Cancer Institute (NCI) in consultation with the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP). The NCI CIRB will serve as the IRB of record for these studies.

  • UTHSCSA will accept NCI CIRB review for all NCI sponsored cooperative group cancer trials
    • Check the NCI CIRB website (https://www.ncicirb.org/) and confirm the study to be opened is on the NCI CIRB menu. Select “Current List of Studies Under CIRB Review”
  • Available sites are in San Antonio limited to: UTHSCSA, University Health System (UHS), Doctors Hospital at Renaissance (DHR)

Instructions for submission:

 

1. Stage 1

2. Stage 2

3. Stage 3

    • For first time users only, complete an Annual PI Worksheet About Local Context. Use the UTHSCSA Specific Information Template to complete this worksheet.
      • OCR analysts can grant access to the system if needed
    • Complete an NCI CIRB Study-Specific Worksheet About Local Context.
    • If you need additional assistance with the NCI forms, review the NCI CIRB Instruction Manual for Worksheet Completion in IRBManager:    https://www.ncicirb.org/ 
      • Select “How it Works”, Then “Independent Model Information”

4. Stage 4

  • Provide Overall PI IRB approval letter
  • Provide Site IRB approval letter
  • Provide IRB approved Informed Consent document(s) with local contact info/HIPAA
  • Submit all forms to the assigned OCR analyst.

5. Stage 5

  • An institutional activation letter from each participating site (i.e. UTHSCSA, UHS) is required prior to initiating your research.

 

  Form Instructions MS Word/ PDF / Link

Required Forms for Initial Submission

 

Research Common Application Step 1 Form

*Required doc for PC
 

NCI CIRB Signatory and/or Component Institution Personnel form

*Required with Step 1 Form.
Access this form from NCI CIRB, as applicable, for first time users or to request updates.
doc for PC
 

Research Common Application Step 2 Form

*Required doc for PC
  Inst-M - Personnel Form *Required with Step 2 Form doc for PC
 

Local Informed Consent Document with local boilerplate language (English version)

*Required with Step 2 Form.
NCI IRB approved informed consent document should be submitted with local boilerplate language provided here.
Note - Also use the Spanish version if applicable.
doc for PC
 

Form A - Signature Assurance Sheet

*Required with Step 2 Form.

Form A-Instructions

How to digitally sign Adobe forms

pdf for PC

Submit as applicable - Submit these forms if applicable to your research

  Local Informed Consent Document with local boilerplate language (Spanish version) This form should be submitted with Step 2 Form, as applicable.  
 

Form Y - Monitoring Plan - Lead PI

This form should be submitted with Step 1 Form, as applicable. Guidance and form link is contained within the Step 1 Form. doc for PC
 

Form Inst-F - Investigational Drug Information Record Form

This form can be submitted with Step 1 or Step 2 Form, as applicable.  Guidance and form links are contained within the Step 1 Form. Do not resubmit with Step 2, if already submitted with Step 1 form. doc for PC
  Form O - Drug or Biologic Being Tested in Research This form can be submitted with Step 1 or Step 2 Form, as applicable.  Guidance and form links are contained within the Step 1 Form. Do not resubmit with Step 2, if already submitted with Step 1 form. doc for PC
  Form P - Use of an Investigational Device in Research This form can be submitted with Step 1 or Step 2 Form, as applicable.  Guidance and form links are contained within the Step 1 Form. Do not resubmit with Step 2, if already submitted with Step 1 form. doc for PC
  Form Inst-H - Local Investigator FDA-Sponsor Form This form can be submitted with Step 1 or Step 2 Form, as applicable.  Guidance and form links are contained within the Step 1 Form. Do not resubmit with Step 2, if already submitted with Step 1 form. doc for PC
  RABT (Research Activity & Billing Trigger)
(available on the CTO website)
This form can be submitted with Step 1 or Step 2 Form, as applicable.  Guidance and form links are contained within the Step 1 Form. Do not resubmit with Step 2, if already submitted with Step 1 form. Webpage
  Local Informed Consent Document with local boilerplate language (Spanish version) This form should be submitted with Step 2 Form, as applicable. doc for PC
  Form L-1 - Find a Study Recruitment Website This form should be submitted with Step 2 Form, as applicable.  Guidance and form links are contained within the Step 2 Form. doc for PC
  Form Q - Use of Radiation in Human Research Studies This form should be submitted with Step 2 Form, as applicable.  Guidance and form links are contained within the Step 2 Form. doc for PC
  Form Q-1 - Gene Transfer Therapy in Human Research Studies This form should be submitted with Step 2 Form, as applicable.  Guidance and form links are contained within the Step 2 Form. doc for PC
  Form X - Protocol-Related Conflict of Interest This form should be submitted with Step 2 Form, as applicable.  Guidance and form links are contained within the Step 2 Form. doc for PC
  Form Inst-J - Request for Approval - Research Involving Child Protective Services This form should be submitted with Step 2 Form, as applicable.  Guidance and form links are contained within the Step 2 Form. doc for PC
 

Form Inst-G - Pharmacy LOU

This form should be submitted with Step 2 Form, as applicable.  Guidance and form links are contained within the Step 2 Form. doc for PC

Request for Modification to External IRB Study - Submit if applicable

  Request for Modification to External IRB Studies for Local UTHSCSA Approval This form should be submitted if a modification is requested. doc for PC
 

Forms should be submitted as attachments in an e-mail to OCR Mail@uthscsa.edu

Links for the NCI CIRB Submission

  Annual PI Worksheet About Local Context For first time users or to provide an annual update, complete an Annual PI Worksheet About Local Context. Use the UTHSCSA Specific Information Template to complete this worksheet.
Webpage
  NCI CIRB Study-Specific Worksheet About Local Context For assistance with NCI Forms, got to https://www.ncicirb.org/ - Select “How it Works”, Then “Independent Model Information”
Webpage