The Blue Line outlines the processes specific to the design, start-up and conduct of Investigator Initiated Clinical Research.

Investigator Initiated Clinical Research includes/refers to the following:

  • Studies designed, written and initiated by ISMMS faculty
  • Studies where ISMMS faculty holds the IND/IDE (if applicable)
  • Studies funded by government agencies (NIH, state), Non-Profit (foundations) or For-Profit entities (including the supply of a drug or device)
  • Subawards (incoming and outgoing)


Use the “Stops” on the Blue Line to navigate ISMMS research processes and procedures throughout the Investigator Initiated Clinical Research project life cycle.

Note: Refer to the Green Line for guidance specific to Industry Initiated Clinical Research.

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