Yes, Version 3.0 of the SMART IRB Reliance Agreement will continue to include flexible provisions, as was allowable in Versions 2.0 and 1.0. The SMART IRB Team recommends utilizing the Implementation Checklist to document flexible arrangements. Additionally, the SMART IRB offers several versions of the Letter of Acknowledgment available that encompass the flexibility often seen under ‘flexible terms addendum’ documents with the launch of V3.0.
Articles in this section
- V3.0 transition: key dates
- Is joining the 3.0 Agreement required?
- I want to learn more about Version 3.0. Where should I go to find out more about the new agreement?
- Does my institution need to sign the Version 3.0 indemnification provision to join Version 3.0?
- Check an institution's V3.0 status
- Does Version 3.0 include flexibility like Version 2.0 and 1.0?
- How do sites determine whether the SMART IRB SOPs will be used?
- What happens to existing V1.0/V2.0 studies?
- Can sites that choose not to rely on the Reviewing IRB still participate in the study?
- How does HIPAA work under Version 3.0?
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