UCSF Office of Research Guidelines for Clinical Research Monitoring

Updated 07/30/21    

As of June 10, 2021, clinical research study monitors are allowed to return to the University of California San Francisco (UCSF), while adhering to all COVID-19 guidelines and policies in-effect. Monitors must complete the UCSF Vendor & Campus Guest Daily Health Screener and follow all protocols applying to Vendors coming to UCSF as shown here: https://coronavirus.ucsf.edu/campus-protocols/vendors.

The Office of Research has instituted the following additional procedures for visiting study monitors to ensure UCSF can meet the needs of our sponsors while ensuring the continued safety of our staff, research participants and visitors.

  • Whenever feasible, the Office of Research strongly recommends postponing all monitoring visits to UCSF or using remote monitoring.
  • Site Initiation Visits should be done remotely. Zoom video conference system is available for that use.
  • Non-essential monitoring visits: Monitors must use MD Link, Veeva SiteVault or other approved remote monitoring methods unless on-site monitoring is essential to participant safety/study integrity. 
  • Essential monitoring visits:
    • Remote monitoring visits should be considered as a first option. On-site visits should only be scheduled for monitoring that is essential to participant safety and/or study integrity (e.g., critical data locks, safety reviews, regulatory inspections or sponsor audits, etc.) where remote monitoring is not feasible.
    • The study Principal Investigator must approve the request for an on-site visit. Monitors must justify why the objectives of the site visit cannot otherwise be accomplished virtually. Where possible, the monitor should request the visit at least 4 weeks in advance to allow for the study team to arrange for the appropriate space, while maintaining social distancing requirements.
  • For essential monitoring visits that cannot be postponed or conducted remotely:
    • Monitors coming from outside California or who have traveled outside of California in the previous 10 days: follow UCSF Vendors policy for requirements on quarantine/testing based on vaccination status. When testing is required, monitors may continue to work on-site while waiting for results of the test.
    • Study teams are responsible for coordinating with monitors and their employers the logistics of testing monitors for on-site visits. The costs of testing monitors must be covered by the CRO or sponsor unless otherwise agreed to with the study PI in writing.
  • Monitors who must come to UCSF for on-site visits are required to affirm that they agree to and are compliant with UCSF’s COVID-19 prevention measures in the checklist below, either in writing (email or letter) or verbally with a study team member one day prior to the first day of the visit. 
  • Upon request, monitors must provide a copy of their employer’s COVID-19 prevention and safety measures for review and comment by the PI or their delegate as required by Cal/OSHA standard Title 8 Section 3205, applicable even if the monitor’s employer is out of state. Monitors must also be able to demonstrate completion of training as required by Section 3205.
  •   Research programs are responsible for determining the best use of Clinical Research Coordinator (CRC) time while they are on campus and study monitors should be informed that the research team may not be able to accommodate all monitoring requests. Whenever feasible, follow-up for action items should be done by phone or zoom.
  • Monitors must inform the PI and research team which charts and files will be reviewed at least 2 weeks prior to the visit, so that the charts and files can be prepared ahead of time.
  • In addition to physical distancing, the space provided by the UCSF study team to the monitor during the visit should prevent or limit the duration of contact with any UCSF personnel as much as possible. Monitors should remain in their assigned space and are not allowed to use common ‘gathering’ spaces in the building e.g. break areas. 
  • Monitors in clinical environments must be pre-approved by the clinical unit leadership. The UCSF study PI or their delegate are responsible for obtaining this approval.
  • Monitors who have had a positive test for COVID-19 in the past 30 days, or who are ill or have any symptoms of or known exposure to COVID-19 in the past 14 days are not allowed on any UCSF campus and must reschedule their monitoring visits.
  • Exceptions to any procedure in this document require approval by the Office of Research before monitors can be allowed on-site. Requests for exception approval should be sent to [email protected]

Information, updates and policies related to COVID-19 restriction and operations at UCSF are available on the UCSF COVID-19 website (https://www.ucsf.edu/coronavirus).

If you have any questions, please do not hesitate to contact the corresponding PI and/or the Office of Research at [email protected]