As we gradually resume in-person clinical and human subjects research visits, we are allowing in-person, external research monitoring visits on a very limited basis. We are currently in a transitional Orange phase in which clinical and human subjects research resumes, but strict controls and monitoring of safety procedures must be implemented. During the Orange Phase, only potentially beneficial clinical and human subjects research are allowed to resume. See the Guidelines for Clinical Research Transitions between Levels.
For routine, interim monitoring requirements from external sponsors and CROs, we strongly encourage you to continue to ask our research sponsors to conduct those remotely. The Monitoring Guidance details the steps for external monitors to access our electronic health record (EPIC) for the purposes of source data verification.
For certain research visits that cannot be done remotely, such as Site Initiation Visits and/or Site Close-Out Visits, or visits from regulatory agencies, they are allowed to be conducted on-site and in-person, provided safety precautions are implemented and monitored. Any visitor on campus, including research monitors and regulators, should be screened for any symptoms concerning for COVID-19 infection. These symptoms include: fever, cough, sore throat, shortness of breath, loss of taste or smell, or nasal congestion or a runny nose that are different from usual seasonal allergies. The monitors or visitors should be screened by phone 1 business day prior to the scheduled on-site visit. Cancel any study monitoring visits if anyone has developed these symptoms. In addition to screening, any visitor should be reminded to practice social distancing, hand hygiene, mask wearing and frequent surface disinfection while on-site. For policies and best practices related to this, please visit the Faculty Practice Plan’s website. In particular, refer to Social Distancing, Hygiene and Workplace Safety Measures (PDF), as well as Office Cleaning Protocols (PDF).
See Monitoring Guidance and FAQs for additional information.