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

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.

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
• Restricted documents (masked/blinded studies) and site business documents require additional access; see the sections below for more information.

Restricted Documents

Restricted documents have limited visibility to avoid revealing private information or due to the study being masked or blinded. To view Restricted documents a user must have Restricted access granted at the study level. An Administrator can grant Restricted access to Monitors and External Users.

Site Documents

A Monitor or an External User can request access to the site’s business process documents, such as standard operating procedures (SOPs), work instructions, or policy memos. These are stored in the Site Documents eBinder, which is not visible to non-site staff users. However, sites can share these documents with Monitors/External Users on an individual document basis, accessible to them through a report.