Clinical Research Sunrise Requests

All PIs conducting clinical research must submit (either individually or as a research group/team) a Portfolio Plan via REDCap (Clinical Research Sunrise Form). A “portfolio,” in this instance, refers to a PI’s or research group’s total set of protocols. The Clinical Research Sunrise Implementation Process will not dictate the protocols that make up each Portfolio Plan, rather, department chairs and center leadership are expected to provide direction to the PIs in their department/center. As an example, an entire division may decide to create a division-wide Portfolio Plan because of the internal resources they use to conduct their research. Alternatively, a single PI may submit a Portfolio Plan on their own.  

Medical School department chairs and OACA center leadership are expected to ensure PIs’ protocols are only included in a single Portfolio Plan. Therefore, as PIs and research teams begin to formulate their Portfolio Plans, they must work in consultation with their Medical School department head or OACA center/unit director. PIs and research groups should view this as an iterative development and review process. Medical School department heads and OACA center/unit directors must sign off on all Portfolio Plans.

Clinical Research Portfolio Plans include two documents:

1. Narrative Form (Word Document)
   The Narrative Form collects information on mitigation of employee risk and the overall clinical research sunrise strategy.
2. Data Form (Excel Document)
   The Data Form collects information on protocols, personnel, and monitor visits.  

These documents must be submitted via a REDCap form and use the following format for the document title: Department or Center_PI Last Name or Research Group Name_Date of Submission_Narrative Form or Data Form.

As PIs and research groups complete their Portfolio Plans, they should keep the following in mind:

• PIs and research groups are expected to prioritize their work, so their work in Sunrise Step 1 does not exceed 50% of face-to-face interactions under normal, pre-COVID-19 operations. This prioritization could be based on effort, trials, or other measures. It is up to PIs/research groups to determine how to prioritize their work. As an example, PIs/research groups could sunrise 100 percent of their trials at 50 percent enrollment. Alternately, they could sunrise 50 percent of their trials at 100 percent enrollment.
• Not every clinical study will be allowed to resume on campus in the first steps of the sunrise process. For example, if the patient population is at particular high risk for COVID-19 and the risk outweighs the potential benefit of the study, the study may not be allowed to resume at this time.
• Every effort should be made to change protocols to do as much by virtual visit as possible. Most industry-sponsored studies and NIH clinical trials have been open to adaptation of the protocol to make it as safe as possible.
• We will continuously review and evaluate infrastructure needs to determine if there are better or more efficient ways to support clinical research.
• Any COVID-19 related requests (no matter the tier) must continue to utilize the Studies of the COVID-19 Virus REDCap form.