Process Describing the Pathway from Initial IRB Submission of a Protocol to Approval of a Study Site Agreement (SSA) and Distribution of Site Agreement.

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Presentation transcript:

Process Describing the Pathway from Initial IRB Submission of a Protocol to Approval of a Study Site Agreement (SSA) and Distribution of Site Agreement Approval Letter (SAL) Granting Permission for Initiation of Study Activity PI/Clinical Research Coordinator (CRC) Gather Protocol, Data Collection Sheet and HIPAA Waiver Documentation Form (if needed) Clinical Research Compliance Office (CRO) Director Develop SSA and SAL Email SAL to PI, IRB Chair, & CRC UMC Legal Review and approve SSA Log in SSA UMC VP Support Services Sign SSA TTUHSC Director of Contracting Sign SSA Scan & return TTUHSC Department Chairs