Review and Approval Process: Clinical Research Sunrise
Once a PI/research group submits their Portfolio Plan (including Medical School department head or OACA center/institute/unit director approval) through REDCap, the documents will be reviewed by the Clinical Research Sunrise Committee. PIs/research groups should expect an iterative review process prior to receiving a recommendation for approval.
We ask for your patience as we go through this process as all of these activities are new, and we are trying to anticipate challenges and problems. The committee will work as fast as it can through this process, but there is no specific timeline for when approvals will be given. There will be unanticipated issues that the committee will need to sort through. It is important to understand that as the committee reviews the Portfolio Plans, it will likely identify key infrastructure needs that could facilitate a safer environment for resumption of clinical research activities. For example, PIs might have a study visit that involves only a blood draw, which is an activity common to many studies. It might make sense to set up stations around the Twin Cities where this can be done without having the participant come to campus.
Upon a recommendation for approval through the Clinical Research Sunrise Implementation Process, the PI/research group will receive a letter of support for their Portfolio Plan from Dean/Vice President Tolar and Vice Dean Schacker. PIs should submit this documentation to the HRPP/IRB for any Tier 2-5 requests; OVPR/HRPP/IRB will need to sign off on any plan to resume a clinical trial or clinical research.
After PIs/research groups receive documentation of support for their Portfolio Plan, employees should begin the return-to-work authorization process. Based on the approved plan, employees should submit their Request to Return forms based on the Clinical Sunrise Step they will resume work on-campus. Each employee should route their form to the PI, and PIs should route the forms to the Medical School department head or OACA center/institute/unit director for final approval/sign-off. Forms should not be submitted for Clinical Sunrise Step 2 until we have entered that stage of the Clinical Sunrise Implementation Process.