March 13, 2020
The University of Florida and UF Health, in an effort to enhance the safety of the local community, patients, and research teams, is temporarily closing access for in-person monitoring visits and scheduled meetings by clinical study sponsors. This closure will remain in effect until April 30, 2020 due to circumstances related to current and anticipated impacts of COVID-19. At that time this procedural change will be reassessed.
For new studies in which a study initiation visit (SIV) has been scheduled, we are requesting sponsors allow remote SIV (i.e. Zoom, Skype, WebEx etc) or postpone their visit.
Remote monitoring will be assessed on a case-by-case basis. Requests for remote monitor access can be made by study teams following the standard process. Sponsors will need to work directly with study teams during this closure to determine if remote access is appropriate for the nature of the required monitoring.
For federally funded projects, it is critical that we follow applicable regulations. Specific guidance for NIH is available and continues to evolve – See https://grants.nih.gov/grants/natural_disasters/corona-virus.htm. In some cases, it may be appropriate to coordinate with your award program and grant management staff. Questions should be directed to Stephanie Gray firstname.lastname@example.org at UF|Research Sponsored Programs.
Please provide this policy to your study sponsors as necessary. As new information becomes available regarding the COVID-19 response, this policy may be updated and/or the visitor restriction lifted.
Brian J. Sevier, Ph.D. | COO, Clinical and Translational Science Institute | Director, Office of Clinical Research | 2004 Mowry Road | PO Box 100219 | Gainesville, FL 32610-0219