№ files_lp_3_process_7_090575
Institutional guidance outlining procedures, responsibilities, communication processes, and reporting requirements for Relying Site Study Teams participating in multi-site research under a Reviewing IRB operating through the SMART IRB Agreement.
Document Type: Institutional guidance document
Subject: Reliance arrangement procedures and study team responsibilities
Related Agreement: SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement
Governing Procedures: SMART IRB Standard Operating Procedures (SOPs)
Issuing Body: Reviewing Institutional Review Board
Applicable To: Relying Site Study Teams
Scope: Multi-site research relying on a single IRB
Key Roles Identified: Lead Study Team; SMART IRB Point of Contact (POC)
Topics Covered: Communication plan; IRB approval preparation; reporting requirements; compliance obligations; key IRB policies
Referenced Materials: Communication Plan; FAQs for Research Teams Relying on an External IRB
Regulatory Framework: Applicable federal regulations; state and local laws; institutional requirements
Lifecycle Coverage: Study activation, conduct, continuing review, reporting, and site closure
Price: 8 / 10 USD
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