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School of Medicine

Submission & Planning Process

The School of Medicine has a Submission and Planning Process that is required for all clinical research studies, regardless of funding source.  This process ensures that all applicable administrative and compliance requirements are met prior to a study becoming active.

Externally-Sponsored Clinical Research:

  • Industry sponsored studies – Initiate the Submission and Planning Process at the time of site selection.
  • For detailed information, please see the SOM Industry Study Planning Guidebook.
  • All other Sponsors – Initiate the Submission and Planning Process at the time of award/Just in time, or when starting the RAMS-IRB submission. This includes all federal, foundation, and non-profit proposals that have a submission deadline.

SOMCT Externally Funded Flow Graph

For a full description, please see SOM Submission and Planning Process for Clinical Research: Externally-Sponsored.

Internally-Supported Clinical Research:

  • For new studies - Initiate the Submission and Planning Process concurrently with a RAMS-IRB submission.
  • For existing studies – Initiate the Submission and Planning Process at the time of IRB continuing review if this process was not previously completed.
  • Abbreviated Review – Internally-supported studies that require minimal effort and will not have any clinical research billing may be eligible for an expedited process (see below).  Examples include: observational studies, chart reviews, data collection studies, etc.

SOMCT Internally Sponsored Flow Graph

For a full description, please see SOM Submission and Planning Process for Clinical Research: Internally-Supported.

For a full description of the Abbreviated process for Internally-Supported studies, please see SOM Process for Abbreviated Review of New Clinical Research Studies.