Resources

The tools and resources in this section are provided to assist institutions in joining SMART IRB and to help IRB and HRPP representatives and study teams develop processes and procedures for using SMART IRB for their studies.

Thank you to the institutions that have agreed to share their resources. Have a resource to share? Contact us at gro.britrams@pleh

For Institutions Interested in Joining SMART IRB
Document Name Source
View the Agreement  
Review the Master Common Reciprocal Institutional Review Board Authorization Agreement.
SMART IRB
SMART IRB SOP Manual  
Standard operating procedures (SOPs) for establishing and implementing reliance provide clarity during the review and conduct of research using the SMART IRB Agreement.
SMART IRB
SMART IRB FAQs  
Frequently asked questions covering eligibility, how to join, agreement provisions, and other important topics.
SMART IRB
How to Join SMART IRB
An overview of the requirements and processes for completing the SMART IRB Joinder process.
SMART IRB
Joinder Checklist  
An overview of the information required to generate your institution's Joinder Agreement.
SMART IRB
Guidance for Affiliates  
A decision tree to help an affiliate of another institution determine how to join SMART IRB.
SMART IRB
SMART IRB Regional Ambassadors
Need help joining and implementing the SMART IRB Agreement? Ask your ambassador.
SMART IRB
Implementing the SMART IRB Agreement: Start-up Package
Document Name Source
Template Letter of Acknowledgement  
If not using the SMART IRB Online Reliance System to coordinate and document study-specific reliance arrangements, institutions may use this template to document the Reviewing IRB and Relying Institutions for a specific study.
SMART IRB
Local Context Survey  

A Reviewing IRB POC may use this survey to obtain key local context information from Relying Institutions.

Download the Local Context Survey as a customizable Word document. 
SMART IRB
Survey for Relying Site Study Teams  

The Overall Principal Investigator and/or Lead Study Team may use this survey to obtain key information from a relying site study team to determine whether particular regulatory or institutional requirements should be communicated to the Reviewing IRB.

Download the Survey for Relying Site Study Teams as a customizable Word documemnt.  
SMART IRB
Communication Plan for Single IRB Review  

Institutions can use this template to document key communication roles, such as submitting initial and continuing reviews, amendments, and reportable events to the Reviewing IRB; providing conflict of interest management plans to the Reviewing IRB; and providing IRB-approved documents and communicating Reviewing IRB determinations to relying site study teams.

Download the Communication Plan for Single IRB Review as customizable Word document. 
SMART IRB
Overall PI (and Lead Study Team) Checklist  

This checklist helps an Overall PI (and Lead Study Team, where applicable) understand and fulfill his/her responsibilities, particularly for studies using the SMART IRB SOPs, which require identification of a Lead Study Team.

Download the Overall PI (and Lead Study Team) Checklist as customizable Word document.  
SMART IRB
Relying Institution PI Checklist  

This checklist helps site investigators and study teams understand and fulfill their responsibilities when a study has been ceded to an external institution.

Download the Relying Institution PI Checklist as customizable Word document. 
SMART IRB
For Institutional Review Board/Human Research Program Staff
Document Name Source
Implementing the SMART IRB Agreement Webinar [video]

An overview of how to implement the SMART IRB Agreement for studies at your institution. Check our homepage for upcoming webinars.

View Slide Deck  
SMART IRB
Online Reliance System
Institutions can use the Online Reliance System to request, track, and document reliance arrangements on a study-by-study basis.
SMART IRB
Template Letter of Acknowledgement  
If not using the SMART IRB Online Reliance System to coordinate and document study-specific reliance arrangements, institutions may use this template to document the Reviewing IRB and Relying Institutions for a specific study.
SMART IRB
SMART IRB Consultations: Expert Advice and Guidance
Prepare to serve as a Reviewing IRB or Relying Institution by consulting with an IRB experienced in the conduct, review, and oversight of multisite research.
SMART IRB
Sample Reliance Registry and Approval Workflow
This flowchart shows the University of California system’s process for creating a new study when using IRB reliance.
UC System Reliance Registry
Recommendations to Advance the Use of Central IRBs  
These recommendations were developed through an examination of barriers to the use of central IRBs for multicenter clinical trials.
Clinical Trials Transformation Initiative
Supporting Communication Between Institutions and Outside IRBs  
This document outlines legal and ethical responsibilities in the oversight of clinical trials, providing a starting point for decoupling institutional and IRB responsibilities.
Clinical Trials Transformation Initiative
Evaluation Checklists for the Use of Central IRBs  
These checklists are designed to assist organizations with adoption of a central IRB model, including institutional self-assessment of readiness, institution/sponsor evaluation of a central IRB, and central IRB evaluation of an institution.
Clinical Trials Transformation Initiative
CITI Module - Single Institutional Review Board (sIRB) Use and Administration: When Serving as an sIRB
The Collaborative Institutional Training Initiative (CITI) Program offers a module about serving as the IRB of Record. Full access requires a subscription.
CITI
Reference Documents
View the Agreement  
Review the Master Common Reciprocal Institutional Review Board Authorization Agreement.
SMART IRB
SMART IRB SOP Manual  
Standard operating procedures (SOPs) for establishing and implementing reliance provide clarity during the review and conduct of research using the SMART IRB Agreement.
SMART IRB
SMART IRB FAQs  
Frequently asked questions covering eligibility, how to join, agreement provisions, and other important topics.
SMART IRB
For Reviewing IRBs
Document Name Source
Local Context Survey  

A Reviewing IRB POC may use this survey to obtain key local context information from Relying Institutions.

Download the Local Context Survey as a customizable Word document. 
SMART IRB
Emory IRB Reliance Agreement Worksheet
This worksheet walks the user through a series of yes/no questions to determine whether a reliance agreement is necessary/appropriate.
Emory University
For Relying Institutions
Document Name Source
Responsibilities of Relying Institutions Webinar [coming soon]

Guidance for institutions preparing to serve as a Relying Institution under the SMART IRB Agreement. Check our homepage for upcoming webinars.

View Slide Deck  
SMART IRB
Sample Requirements for External Consent Templates  
This document provides an example of step-by-step guidance to revise informed consent form templates when relying on an external IRB.
University of Pennsylvania
For Study Teams
Resource Name Source
Online Reliance System
Institutions can use the Online Reliance System to request, track, and document reliance arrangements on a study-by-study basis.
SMART IRB
Communication Plan for Single IRB Review  

Institutions can use this template to document key communication roles, such as submitting initial and continuing reviews, amendments, and reportable events to the Reviewing IRB; providing conflict of interest management plans to the Reviewing IRB; and providing IRB-approved documents and communicating Reviewing IRB determinations to relying site study teams.

Download the Communication Plan for Single IRB Review as customizable Word document. 
SMART IRB
CITI Module - Single Institutional Review Board (sIRB) Use and Administration: When Serving as a sIRB of Record
The Collaborative Institutional Training Initiative (CITI) Program offers a module about serving as the IRB of Record. Full access requires a subscription.
CITI
Considerations for a Single IRB Model
Video presentation covering key considerations when using a single IRB.
University of Utah
For Lead Study Teams
Survey for Relying Site Study Teams  

The Overall Principal Investigator and/or Lead Study Team may use this survey to obtain key information from a relying site study team to determine whether particular regulatory or institutional requirements should be communicated to the Reviewing IRB.

Download the Survey for Relying Site Study Teams as a customizable Word documemnt.  
SMART IRB
Overall PI (and Lead Study Team) Checklist  

This checklist helps an Overall PI (and Lead Study Team, where applicable) understand and fulfill his/her responsibilities, particularly for studies using the SMART IRB SOPs, which require identification of a Lead Study Team.

Download the Overall PI (and Lead Study Team) Checklist as customizable Word document.  
SMART IRB
Sample IRB of Record PI Checklist  
This document provides an example of an institution checklist to help an overall PI understand his/her responsibilities.
MetroHealth
For Relying Institution Study Teams
Survey for Relying Site Study Teams  
The Overall Principal Investigator and/or Lead Study Team may use this survey to obtain key information from a relying site study team to determine whether particular regulatory or institutional requirements should be communicated to the Reviewing IRB.
SMART IRB
Relying Institution PI Checklist  

This checklist helps site investigators and study teams understand and fulfill their responsibilities when a study has been ceded to an external institution.

Download the Relying Institution PI Checklist as customizable Word document. 
SMART IRB
Sample Addition of Site Form
This document provides an example of information to collect when adding a site to a study.
University of Texas
Single IRB Review policy