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.
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
FAQs (Updated April 2020) Frequently asked questions covering eligibility, how to join, agreement provisions, and other important topics.
Letter of Acknowledgement, Template 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
Local Considerations: Institutional Profile Captures institutional, local, and state requirements that a Reviewing IRB may need to apply to its review and oversight of studies on behalf of another institution as well as information about an institution's
IRB(s), if applicable.
SMART IRB Harmonization Steering Committee
Local Considerations: Protocol-specific Document Allows a Reviewing IRB to collect variations across participating sites regarding key information about study teams (e.g., training and conflicts of interests) and variations in study conduct (e.g., ancillary
reviews required; HIPAA requirements; subject population).
SMART IRB Harmonization Steering Committee
Local Context Survey A Reviewing IRB POC may use this survey to obtain key local context information from Relying Institutions.
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.
Relying Site Study Team Survey 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.
SOP Manual, SMART IRB Standard operating procedures (SOPs) for establishing and implementing reliance provide clarity during the review and conduct of research using the SMART IRB Agreement.
Start-up Package for NIH Grant Preparation A suite of resources to help investigators prepare NIH grant applications that require single IRB review; the package provides a guide describing how and when to use the included resource as well as links to online tools and further information.
Start-up Package for Relying Institutions A suite of resources to help Relying Institutions understand and fulfill their roles and responsibilities in a single IRB arrangement; the package provides a guide describing how and when to use the included resource as well as links to online tools and further information.
Start-up Package for Reviewing IRBs A suite of resources to help Reviewing IRBs understand and fulfill their roles and responsibilities in a single IRB arrangement; the package provides a guide describing how and when to use the included resource as well as links to online tools and further information.
Start-up Package for Study Teams A suite of resources to ensure study teams understand and can fulfill their responsibilities related to single IRB arrangements; the package provides a guide describing how and when to use the included resource as well as links to online tools and further information.
Webinar: SMART Talk - Resources for Training Study Teams in Single IRB Provides an overview of training materials and resources developed by SMART IRB that are designed to help investigators and study teams successfully plan for and navigate single IRB review arrangements for their studies; panelists also discuss their experiences preparing study teams for single IRB review, including best practices and lessons learned. View Slide Deck
Webinar: SMART Talk - Single IRB and the Review of Research Involving Children A discussion of the differences that arise between Reviewing IRBs and Relying Institutions surrounding pediatric research, such as differences in assent processes, age of assent, pregnancy testing, risk assessment, and state laws. Panelists speak about their experiences, including how they work with institutions to address disagreements and potential areas for flexibility and harmonization. View Slide Deck