Clinical research reactivation during the COVID-19 pandemic: An academic center process and lessons for the future.

Background: Clinical research is a central mission of the University of Colorado Anschutz Medical Campus (CU-Anschutz). On March 18, 2020, due to rising COVID-19 rates and personal protective equipment (PPE) shortages, an emergency approval process for critical research essential to the care and safety of patients, including COVID-19 trials, was enacted. All other clinical research studies requiring face-to-face visits were placed on hold to protect participant and staff safety.

Methods: A clinical research TaskForce was rapidly assembled, consisting of a cross- section of campus clinical research operations leaders, including affiliate hospitals. This group developed a guidance document and process where the primary prioritization factor was positive therapeutic benefit/risk (Groups 2-5). A REDCap form demarcating items including research visit types and safety plans was designed. A separate Space Plan Committee approval was required to gauge environmental health and safety.

Results: A total of 654 protocols were approved over 31 weeks using this process. Group 2 review and approvals occurred within 5 days of campus reactivation, and 65 days after original clinical research hold. Groups 3 through 5 were opened for submission and review in a phased approach. The majority proactively submitted IRB protocol amendments to minimize face-to-face participant/staff contact. There were no cases of COVID-19 outbreak in research participants.

Conclusion: Clinical research reactivation was rapidly implemented in a transparent, collaborative, broadly supported, and efficient process of staged reactivation while prioritizing the health and safety of participants and staff at CU-Anschutz. This model is practical and easily generalizable to other medical research campuses.