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