Study Monitor Access

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Study Monitor Access

Study monitor access provides monitors (remote or on-site) the ability to access patient and study records in Epic and/or eReg using unique user information.

  • Epic Link is used as a read-only process to review study participant records.
  • eReg is used as a read-only process to review regulatory documentation associated with the study.

CRSO and HCI will act as central points for providing user accounts for study monitors. This request is managed through our Service Now support page. Before granting access, these teams will verify that study monitor information is complete and adequate documentation will be provided.

  • Contact Information (Monitor Name, Organization, Organization Type, Email Address, and Phone Number)
  • Completed HIPAA Training (required annually)
  • Signed Research Study Monitor Confidentiality and Non-Disclosure Agreement
  • Completed eReg training modules (eReg access only): eReg 100 - Navigation and eReg 110 - Using Review Sessions (These will be assigned upon submission of Study Monitor request and will not impact the request process for Epic Link.)
Request Study Monitor Access

Benefits of using Study Monitor Access to Epic and/or eReg

Efficiency

No more “over-the-shoulder” monitoring sessions where study monitors rely on study staff to log in and locate information for them. This is more efficient and keeps study teams focused on other tasks while the monitor is reviewing the study.

Protection of Patient/Study Data

No more access to other patients in Epic. Study monitors will only be given access to the studies and/or participants that are relevant for a particular study visit. With a limited time frame, study monitors can only access the information as assigned in a “review session.”

Accountability

An audit trail will identify which users of Epic Link has accessed the participant’s medical record. This keeps us in compliance with privacy rules.