Research Study Monitor Access

• Find out how Research Study Monitors can get access to approved research study records.

Study Monitors are given limited access to SFDPH EPIC as a Release of Information request.  The following is the onboarding process to request access for Clinical Remote Study Monitor access. 

1. Complete the Health Information Data Use Form. You may use DocuSign for the approvals. 
   • You will be required to have a SFDPH sponsor signature - the "Administrative Representative" (DPH leadership, e.g. ZSFG CEO or SFDPH Director of Ambulatory Care) and a signature from the SFDPH "Program Representative" (the representative from the SFDPH program whose patients/staff are most impacted by the research).  
   • You will be required to collect the study sponsor/monitoring signature.
   • The completed form should be submitted to datasharing@sfdph.org for approval by the Office of Compliance and Privacy Affairs (OCPA).  You will receive notice that OCPA has approved the request.  
2. Ensure that the RSH Record (Study Record) is built in EPIC.
3. Once Steps 1 and 2 are completed, proceed with the following steps:
4. Submit a Service Now ticket to the SFDPH Service Desk (dph.helpdesk@sfdph.org) for a new research study for the Epic CareLink Team.
   • Provide:
     • The RSH Record Name.
     • The Study Code.
   • Attach:
     • The approved Health Information Data Use Form.
5. Along with Step 4, submit new Research Study Monitor account requests through the link below with the specific name(s) of the remote study monitor and the specific study ID for the access.
   • Research Monitor Account Request.
6. You will receive notification via the Service Now ticket once the request has been processed and the Study Monitor’s Epic CareLink account has been created.
   • Refer to the Release of Information Study Monitor Tip Sheet on how to send identified study participants to the Study Monitor for review.

Studies that have already submitted and been approved for Study Monitor access and need to add or change the Study Monitor do not need to complete another Data Use Form. 

The Clinical Research Coordinator should follow the Research Study Monitor Onboarding Process (available in the Clinical Research Coordinator Learning Home in Epic) to add a new Study Monitor.