Additional Information Now Required for eIAFs for Clinical Trial Research Projects with Human Subjects

For PIs who include human subjects on their clinical trial sponsored research projects, the SRAS Grants Proposal Specialist (GPS) will now ask you or your staff members for a “Study Personnel Sheet” (also called an “F5”) during electronic Internal Approval Form (eIAF) preparation.  This is the sheet that the PI submits to UK’s Office of Research Integrity (ORI) as part of his or her IRB submission.  This step will ensure that all investigators are included on the eIAF and have completed a COI disclosure.  Any sub-investigator or other person who qualifies as an “investigator” under UK’s Administrative Regulation 7:2 must be included on the project’s eIAF and must complete a COI disclosure.  This step will also help to minimize eIAF re-routing, which occurs when an investigator is not listed on the eIAF.