Study Plan

Information to Gather

  • What are the projected start and end dates for the study?
     

  • Are there any study specific deadlines related to execution of the agreement?
     

  • Where will the work be performed? Provide specific addresses.
     

  • What is the study material being investigated?
     

  • Will University staff be in control of the performance for the entire study (i.e. will any portion of the treatment be done by the patient at the patient’s home, by a home health care service, or by an outside institution)?
     

  • Will the sponsor provide the study material, will the University purchase study material, or will insurance pay for the study material?
     

  • What is the status of the study material? For example, is it on the market or approved in other countries but not in the US? Is this a new use?
     

  • Are there other treatments available for the condition under study?
     

  • Are the other parties requesting access to identifiable patient information?
     

  • Did the University -- or anyone performing the study -- contribute to the development of the study material or procedures (either as part of University or otherwise)?
     

  • Are the proposed publication provisions acceptable to the PI and the University, and consistent with the anticipated publication plan?
     

  • Is there a time requirement for completing data entry in the case report form and/or adverse event reporting (e.g., 24 hours from visit, 3 days from visit vs. 3 business days)?  Can you meet the timelines?


Reminders

  • The ‘pre-proposal’ process is generally managed by the PI and department to secure funding for IITs.
     

  • The contracts office does not review proposals for clinical trials.
     

  • The PI or department should consult with their Contracts and Compliance Offices, or Conflict of Interest Committee if they have any concern that the funding entity is requiring intellectual property, confidentiality or other rights, or creating obligations that may interfere with the study in a pre-proposal.

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