Rapid Response Expedites COVID-19 Related Studies at Emory

In January 2020, the Georgia CTSA Quality & Efficiency program finalized their SOP for the Rapid Response Team to obtain fast-track approvals across the Emory system. This new SOP allows for the coordination of needed approvals within 48 hours. The process was a collaboration, with Office for Clinical Research (OCR) leading Emory’s Rapid Response Team (RRT).

Emory’s first COVID-19 patient began receiving infusion therapy as a result of this new Rapid Response Team SOP.  More coverage of this first patient can be found in Georgia CTSA’s published article here.

The overall process of rapid review at Emory is facilitated by Sherry Coleman, DNP, RN, CHRC, CHC. Dr. Coleman is the Associate Executive Director of Emory OCR’s Invoicing and Clinical Research Support Service teams and supervises the Clinical Research Navigator team for the Georgia CTSA. As the facilitator, she works non-stop with all teams involved to initiate relationships and alleviate any barriers as they occur. This includes sending reminders, calling, texting and following-up at any time (after hours and on weekends) when necessary to ensure that any preventable delay is addressed.

All RRT submission forms go through the following review process:

  • RRT Facilitator receives the RRT Submission Form from study teams with required documents.
  • Coleman, along with Robin Ginn (AVP, Research Administration and Executive Director, OCR), review the submission to determine if protocol meets criteria based upon the Standard Operating Procedure (SOP) Qualifying Criteria.
  • If the criteria is met and all necessary documents are received, Dr. Coleman notifies the study team and deploys the RRT by standardized email utilizing the Point of Contact (POC) list in the SOP.
  • Each Office of Research Administration department assigns the trial to a team representative to begin review.
  • All teams are copied on emails across departments throughout the process to ensure that we are all aware and updated – contributing to concurrent process approvals.

Since the introduction of the Emory Rapid Response Team and SOP in light of COVID-19, A total of 11 studies have been completely processed through the Rapid Response Team. As of April 30, ten have completed the process and one is pending.

The metrics for completed in mean/median (calendar days) are as follows:

  • RRT Activation to Open Enrollment
    • 4 days (mean)
    • 4 days (median)
  • RRT Activation to OCR Budget/PRA Completion
    • 2 days (mean)
    • 2 days (median)
  • RRT Activation to CTA Execution
    • 4 days (mean)
    • 5 days (median)
  • RRT Activation to eNOA Issue
    • 5 days (mean)
    • 5 days (median)

While there are currently 11 studies that are officially labeled RRT studies, OCR also worked to expedite a COVID-19 related contract with joint collaboration of the CDC Surveillance project, Georgia CTSA, Emory Office of Sponsored Programs, Emory Research Administration Services, and Dr. John Roback.

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