Emory's first coronavirus patient began receiving infusion therapy yesterday as a result of Georgia CTSA's assistance in coordinating the approvals needed within 48 hours. Georgia CTSA's Navigator Team utilized the new Standard Operating Procedure (SOP) for its Rapid Response Team service to obtain fast-track approvals across the Emory system.
Sherry Coleman, DNP, RN, CHRC, Georgia CTSA Associate Director of Clinical Research Support Services and Associate Executive Director of Clinical Trials at Emory University says, "The protocol had already been written and submitted. We needed to fast-track this study since there was a patient who had been identified. We coordinated the team effort for all Emory departments to come together to make it happen within 48 hours."
In January 2020, the Georgia CTSA Quality & Efficiency program finalized their SOP for the Rapid Response Team to expedite high priority studies of experimental therapeutics for pre-award approval. This was a key initiative following lessons learned from the response to H1N1, Zika, and Ebola. Representatives from the IRB, the Office of Clinical Research, Grants and Contracts, and other offices as necessary worked in real-time together and in parallel to expedite these studies. A standard procedure and the identification of key staff were recognized as critical components to the successful achievement of rapid implementation and to ensure that the process moves forward successfully.
"When we established this team, we brought all these points of contact together to develop the SOP. Everyone knew they were a part of this team and that we would be reaching out when responding to a rapid response situation. The flow chart we created reflects each group's course of action. Starting when a situation has been identified, we then deploy, contact, and reach out to each department. The timeline we originally agreed to was seven days, contingent upon patient safety or government directive, which in this case was within 48 hours," adds Coleman.
Now that the procedure has been finalized and is in place, this approach will be used across the Georgia CTSA partnership including at the Morehouse School of Medicine (MSM) to adapt similar procedures and share joint expertise.
The Georgia CTSA is a statewide partnership between Emory, MSM, Georgia Tech, and UGA and is one of over 60 in a national consortium striving to improve the way biomedical research is conducted across the country. The consortium, funded through the National Center for Advancing Translational Sciences (NCATS) and the National Institutes of Health's Clinical and Translational Science Awards, shares a common vision to translate laboratory discoveries into treatments for patients, engage communities in clinical research efforts, and train the next generation of clinical investigators.