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 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 specific study.
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.