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Basis of CRI Review

All proposals will be reviewed for:

  • Feasible: Adequate subjects & expertise, affordable in terms of time & money and manageable in scope
  • Novel: Confirms, refutes or extends previous findings
  • Ethical: Acceptable treatment of subjects with adequate confidentiality
  • Relevant: Related to advancing scientific knowledge, clinical & health policy, or future research

Investigator Responsibilities

The expectations for the PI and Co-PIs that they:

  • Make certain they stay involved and the members of their team are following the SOM Policy requiring that all individuals; including subjects and staff; are treated courteously, respectfully and with dignity
  • Are active participants, involved to some extent at all levels
  • Complete the CITI training with all personnel on the study
  • Know and understand the details of the protocol
  • Assist in identifying eligible subjects or appropriate charts
  • Know how to log into iRIS, study sites and eCRFs
  • Arrange regularly-scheduled meetings with the study team to discuss study events progress and questions that arise
  • Attend the pertinent meetings and teleconferences
  • Ensure that all team members are totally familiar with the regulations and are adequately trained and qualified for the tasks assigned to them
  • Assist in identification and enrollment of subjects
  • Hold meetings monthly or more frequently, as necessary to make certain that the study is progressing as expected and to discuss possible changes
  • See also FDA Form 1572 for a listing of investigator responsibilities
  • Review also: FDA Guidance on Investigator Responsibilities