External monitors/auditors may be given limited time access to view Review Sessions in eReg. In order to request access, the study staff must submit a request by email to regulatory@arizona.edu. The request should include the following documents:
- eReg External Monitor Account Request Form – this should NOT be signed, as it will be signed by UAHS Research Administration
- eReg NDA and Acceptable Use Form signed by the monitor/auditor
- Advarra University completion certificates for Advarra eReg 100: Navigation eLearning and Advarra eReg 110: Using Review Sessions eLearning, if available. If the monitor does not have an Advarra University account, the IT staff will set up an account for them and assign the required trainings.
- A copy of their Information Security Awareness training certificate (must have been completed within the past 365 days). This does NOT need to be the UA training.
Monitors should be given access to the specific study information and documents that they need to review via Review Sessions. Study staff are responsible for creating Review Sessions in eReg. For information on this process, you may review the Advarra University module Advarra eReg 109: Creating Review Sessions eLearning.
For more information on monitor access, please review the COM-T IT eReg External Monitor Access Management and Account Provisioning Procedures.”