Office of Clinical Research (OCR)

OCR - SMART IRB Agreement

 The SMART IRB’s Online Reliance System (SIORS) allows for investigators to request, track, and document reliance arrangements.

 

The following institutions have signed the SMART IRB Agreement that may allow the IRB from one site to review and approve a research study for all sites participating in the study: https://smartirb.org/participating-institutions/


SMART IRB video: https://vimeo.com/207505758

 

Available sites in San Antonio are limited to: UTHSA, University Health System (UHS)

 

Pre-submission: OCR Consultation
Determine who should initiate submission to SMART IRB (normally the Lead PI)

  • The Site PI/Study Staff must discuss reliance plans with a representative from the OCR (210-567-8555 or OCRMail@uthscsa.edu).  
  • During this time, the following SMART IRB resource forms will be administered and discussed with Site PI/Study Staff:
    • Communication Plan/Standard Operating Procedures
    • Relying Institution PI Checklist
    • Overall Lead PI Checklist

Note:    Use of a commercial IRB may not require this information.   However, it is very important to contact OCR prior to submitting in the SMART IRB system as institutional requirements and system access must be established for use of a commercial IRB.

Instructions for submission to SMART IRB:

IMPORTANT: Submission to the OCR (see below) is required within 24 hours of submitting through  SMART IRB.   Do not submit to SMART IRB prior to OCR consultation.

 

Instructions for submission to OCR:

 

1. Stage 1

    • Complete Research Common Application Step 1 Form
    • Submit to OCR via the automated email (attach copy of protocol and consent form)
    • NOTE: Stage 1 Form can be submitted alone for early notification. Stage 2 Forms are required. It is recommended that you submit them at this time if possible.

     

2. Stage 2

3. Stage 3

  • Submit to the IRB of record
    • Must use consent form with local context and HIPAA information that was reviewed by OCR

4. Stage 4

  • Submit IRB Approval Letter and Informed Consent Document(s) to 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

Required Forms for Initial Submission

 

Research Common Application Step 1 Form

*Required 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
 

Form A - Signature Assurance Sheet

*Required with Step 2 Form

How to digitally sign Adobe forms

pdf for PC

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

 

Form Y - Monitoring Plan - Lead PI

This form should be submitted with Step 1 Form, as applicable. Guidance and form link 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
 

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 OCRMail@uthscsa.edu