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

 

Updated  August 25, 2020

External Monitor Onsite Visits

Beginning September 1, 2020, external monitor onsite visits for clinical research protocols will once again be permitted under limited circumstances. In particular, remote monitoring is the preferred approach and should be used to the extent possible. Onsite monitoring should be reserved for the rare circumstance when an onsite visit is required and should be limited to the review of items that cannot be conducted remotely. The monitor must provide a list of items for onsite review at least 3 days in advance of the visit along with a justification outlining why the review must occur onsite.  Study teams may request permission to proceed with the on- site visit by contacting the JHM Compliance Monitoring Program at JHM_OHRP_CMP@jh.edu. A copy of the onsite review plan and justification must be supplied with the request. If permission is granted for the onsite visit, 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 symptoms prior to entry into the building. In addition, the monitor is expected to not have traveled to another 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.  In the event that an onsite SIV is required, study teams may request permission to proceed with the on- site visit by contacting the JHM Compliance Monitoring Program at JHM_OHRP_CMP@jh.edu. If permission is granted for the onsite site initiation visit, 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 travelled to another site in the past 14 days.