Overview
For nearly a decade, CTTI has championed the adoption of single IRBs (sIRBs) for multicenter clinical trials in an effort to streamline and optimize study execution.
Use the following resources to adopt an sIRB model:
- Recommendations and resources to address barriers to using sIRBs for multicenter clinical trials and for driving sIRB implementation
- Resources for determining institutional engagement
- A case study of the IMPACT-AFib trial's successfully implementation of an sIRB framework
CTTI also collaborated with an NIH workgroup to develop a comprehensive plan for assessing the NIH's sIRB policy. The final evaluation framework report describes suggested next steps and key elements to be included in a future evaluation of the sIRB model.
Solutions
Search AllRecommendation Summary
Recommendations
- Recommendations for Using Single IRBS for Multicenter Clinical Trials
- Recommendations for Advancing the Use of Single IRBs for Multicenter Clinical Trials
Resources
- Single IRB: Determination of Institutional Engagement Overview
- sIRB Flowchart: Determining Engagement of Institutions in Research
- Single IRB: Institutional Engagement Scenarios
- Single IRB: Institutional Engagement Definitions
- Use of Single IRBs for Multicenter Clinical Trials Evaluation Checklist
- CTTI Advancing the Use of Single IRBs for Multicenter Clinical Trials: Template IRB Authorization Agreement
- Evaluation Framework for the NIH Single IRB Policy
- Single IRB: Resource of Resources Document
- Considerations to Support Communication between Institutions and Outside IRBs when Responsibilities are Being Assigned for Multicenter Clinical Trial Protocols
- Single IRBs for Multicenter Clinical Trials: Summary of CTTI Recommendations & Resources
- Use of Single IRBs for Multicenter Clinical Trials: Final Report
Related Items
- CTTI Publication Explores Stakeholder Reflections on Implementing the National Institutes of Health’s Policy on Single Institutional Review Boards
- Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance
- Investigators from Multiple U.S. Organizations Collaborate on First Embedded Pragmatic Clinical Trial Using National Health Plans’ Data
- Single IRB (sIRB) Adoption & Evaluation
- Resources to assist in the transition to a single IRB model for multisite clinical trials
- CTTI to Support NIH Workgroup in Developing Evaluation Plan for Single IRB Policy
- CTTI to Support NIH Workgroup in Developing Evaluation Plan for Single IRB Policy
- Are You Ready for Mandated Single IRB Review for Multicenter Clinical Trials?
- Advancing the Use of Central IRBs for Multi-center Clinical Trials in the United States
- Research Institution Perspectives on Advancing the Use of Central IRBs for Multi-center Clinical Trials in the United States
- Research Institution Perspectives on Advancing the Use of Central IRBs for Multi-center Clinical Trials in the United States
- Sponsors’ Perspectives on Advancing the Use of Central IRBs for Multi-center Clinical Trials in the United States
- An Update on the CTTI Use of Central IRBs for Multi-center Clinical Trials Project
- Use of central institutional review boards for multicenter clinical trials in the United States: A review of the literature
- Using Central IRBs for Multicenter Clinical Trials in the United States
- Conducting Multi-Center Trials: New Recommendations and Tool for Research
- Use of Central IRBs for Multi-center Clinical Trials
- Use of Central IRBs for Multi-center Clinical Trials
News
- CTTI Publication Explores Stakeholder Reflections on Implementing the National Institutes of Health’s Policy on Single Institutional Review BoardsA new CTTI publication, published in the Journal of Ethics and Human Research, explores stakeholder reflections on implementing the National Institutes of Health’s policy on single Institutional Review Boards (sIRB). ...