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JHU COVID-19 Requirements for Visits by External Monitors and Site Initiation Visits

Updated October 15, 2020

External Monitor Onsite Visits

Beginning September 1, 2020 external monitor onsite visits for clinical research protocols will be permitted under limited circumstances. Whereas, remote monitoring is the preferred approach and should be used when possible, onsite monitoring is to be reserved for the rare circumstance when an onsite visit is required, with the visit limited to study records or documents that cannot be reviewed remotely. 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. If it is determined that onsite monitoring is necessary the monitor must follow Johns Hopkins safety procedures, including 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 orally screened for COVID -19 symptoms prior to entry into the building. In addition, the monitor is expected to not have traveled to any site in the past 14 days.

Site Initiation Visits (SIVs)

Beginning September 1, 2020, site initiation visits (SIVs) will be permitted onsite when absolutely necessary. Remote SIVs remain the preferred approach and should be used to the extent possible.  The study team must coordinate with any other department or group the monitor may visit (e.g. the Investigational Drug Service) to ensure they can accommodate that request. If an onsite SIV is determined to be necessary, study teams are expected to follow all policies related to COVID-19, including ensuring that visitors are screened prior to coming for an SIV, and follow masking and social distancing protocols. In addition, any sponsor personnel participating in the onsite SIV are expected to not have traveled to any site in the past 14 days.

 

Please see FAQs for more details. Any questions can be directed to the Compliance Monitoring Program at JHM_OHRP_CMP@jh.edu