UCSF Office of Research Guidelines for Clinical Research Monitoring

December 22, 2020

As of June 10, 2020, 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: https://coronavirus.ucsf.edu/campus-protocols/vendors.

Given the December 16th public health emergency order imposing a mandatory 10-day quarantine for anyone traveling, moving or returning to San Francisco from anywhere outside the nine-county Bay Area, updated UCSF Quarantine Order and Travel Guidance, and UCSF Health Visitor Restrictions, 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 while the public health emergency order is in effect (currently until Jan. 4, 2021).
  • 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 or other approved remote monitoring methods unless on-site monitoring is essential to participant safety/study integrity. Information on how to sign-up for MD Link can be found here.
  • 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.
  • For essential monitoring visits that cannot be postponed or conducted remotely, UCSF strongly recommends a 10-day quarantine before the on-site visit for monitors who are coming from or have traveled outside the nine-county Bay Area within 14 days of the visit.
  • If in-person visits must occur before the end of the 10-day quarantine, monitors are required to complete two COVID-19 tests at a minimum. The first test must be completed ideally 2 days prior to the first day the monitor will perform on-site work at UCSF, or else on the first day of on-site work. The second must be completed 5-7 days after the first test. 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. 
    • I have been shown copies of UCSF’s universal masking and physical distancing policies and agree to adhere to them when I am on site
    • I have been shown copies of the UCSF Office of Research Guidelines for Clinical Research Monitoring and agree to comply with the guidelines
    • I will complete the vendor screening app prior to coming onto campus each day and will not come onto campus if I answer “YES” to any of the screening questions
    • I will not come onto campus if I have had a positive test for COVID-19 in the past 30 days, if I am ill, or if I have any symptoms of or known exposure to COVID-19 in the past 14 days
    • Travel: one of the following must be true:
      • I am not coming from and have not traveled outside the nine-county Bay Area in the last 14 days
      • Or: I am coming from or have traveled outside the nine-county Bay Area in the last 14 days but completed a 10-day quarantine before my on-site visit
      • Or: I am coming from or have traveled outside the nine-county Bay Area in the last 14 days but I have completed a COVID-19 test before my on-site visit and will complete a second test on day 5 through 7 after the first day of the on-site visit.
    • I agree to notify UCSF if I test positive for COVID-19 within 14 days of my on-site visit
    • I confirm that I am in compliance with all of my employers policies for COVID-19 screening, testing and quarantining.
  • Upon request, monitors must provide a copy of their employer’s COVID-19 screening, testing, and quarantining practices for review and comment by the PI or their delegate. Monitors may be required to provide their employer’s written COVID-19 Prevention Program 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.
  • 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.
  • Staff capacity on-site remains limited given population density restrictions: https://research.ucsf.edu/. 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]