Monitoring

For inquiries regarding acceptable practices and platforms for in-person and remote study monitoring, please review the guidance provided by the UCSF Office of Research. 

On-site monitoring: The onsite presence of clinical research sponsors and monitors is strongly discouraged at this time and requires pre-approval of the appropriate principal investigator or department head when absolutely necessary. All study teams and monitors must follow the Office of Research Guidelines for Clinical Research Monitoring for onsite monitoring.

Remote monitoring: The Office of Research leadership has been actively working on identifying a durable and privacy compliant remote solution for study monitors.

• “Zoom-hosted remote site monitoring” is approved for remote monitoring. Though not preferred, “Zoom-hosted remote site monitoring” through UCSF’s HIPAA-compliant enterprise Zoom service is acceptable in the interim until a more durable solution is identified
• Monitors can use MD Link for remote monitoring. Please review the guidance on how to sign-up for MD Link.
• A “manual” option being used by some is printing the requested forms, redacting PHI, and sending via secure email as PDFs. It is time intensive and not favored, but can still be used is absolutely needed

Electronic signatures: DocuSign and REDCap are the two platforms currently being used for electronic signatures for all studies, including FDA-regulated trials. Additionally, UCSF is expecting REDCap to be FDA 21 CFR Part 11 compliant in the coming weeks, with DocuSign following shortly after. The FDA COVID MyStudies app is approved for use, but access must be requested by the investigator and the study must possess an IND or IDE. Refer to section 2 of the IRB FAQ.