Update on External Onsite Monitoring and Site-Initiation Visits for Clinical Research Protocols
Updated June 24, 2021
Beginning June 24, 2021 external onsite monitoring and site-initiation visits for clinical research protocols will be permitted under limited circumstances. Whereas, remote monitoring remains the preferred approach and should be used when possible, onsite monitoring may be permitted when no feasible remote alternative is available (e.g., when study records and/or source documents cannot be reviewed virtually). In situations where in-person monitoring is planned, the study team must coordinate with any other department or facility the monitor may visit (e.g. the Investigational Drug Service) to ensure they can accommodate that request. Further, the study team must confirm with the monitor that all current applicable Johns Hopkins safety procedures will be followed, including the mandatory wearing of masks at all times when on campus and maintaining 6 feet of social distancing when possible. The monitor should be met at the entrance to the building by a study team member and screened for COVID-19 symptoms and, if applicable, affirm the monitor is fully vaccinated.
For the most up-to-date information, study teams are advised to review frequently the JHM IRB’s webpage for up-to-date COVID-19 guidelines related to human subjects research at https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information/index.html, and the JHM Guidelines for Visitors at https://www.hopkinsmedicine.org/coronavirus/visitor-guidelines.html.
