Once added to a study, an external user can complete the monitoring of study documents in the approved or steady state.

Access Provides:

• Ability to view and annotate documents in the approved or steady state (major version documents such as 1.0 or 2.0).
• Ability to create monitoring issues and request missing documents.
• Reports monitor/CRA can access:
  • Documents Ready for Monitoring Review (included in the Monitor Review Dashboard)
  • Documents Waiting on Site Response (included in the Monitor Review Dashboard)
  • Monitoring Issues (multiple)
  • New documents since the previous monitoring visit
  • Read and Understand History
• Monitor Review Dashboard

Access Does Not Provide:

• Visibility to any documents in the Draft state.
• Ability to edit, upload, or delete documents.
• Ability to download participant source documents.
• Ability to view financial documents such as contracts or budgets.