Using Reports & Dashboards

Veeva Clinical Basics provides several reports and dashboards to help you monitor your clinical trial metrics.

To view your reports and dashboards, navigate to Reports > Reports or Reports > Dashboards from the TMF Workspace, and click the name of the report or dashboard you want to view.

Reports

The following Clinical Basics reports are available:

  • All Artifacts and Documents: Shows all Artifacts in the TMF Reference Model 3.0, with any documents uploaded for a given Study..

  • All Document Quality Issues (By Document Type): View Quality Issues grouped by Document Type.

  • All Document Quality Issues (By Pre or Post-Approval): Lists a count of documents in each status for each Owning Department. Click a number in the matrix to see the list of documents for that particular status and Owning Department.

  • All Document Quality Issues by Study: View all open and closed Quality Issues for documents within a given study.

  • Artifacts with Documents: Shows the Artifacts in the TMF Reference Model 3.0, where documents have been uploaded for a given Study.

  • Artifacts without Documents: Shows the Artifacts in the TMF Reference Model 3.0, where documents have NOT been uploaded for a given Study.

  • Average Days in Approval Workflow: Calculates the average time documents remains in the Approval with eSignature workflow for a given study.

  • Average Days in QC Review Workflow: Calculates the average time documents remain in the QC Review workflow for a given study.

  • Average Days Quality Issues Remain Open: Calculates the average time Quality Issues remain open for a given study.

  • Average Days to Approval: Calculates the average time a document takes from the created date to date of approval for a specific study.
  • Count of Artifacts by Study Site: Used to support the Site Essential Document Completeness widget on the TMF Overview Dashboard.
  • Filed Site Essential Documents: View all Site Essential Documents that have been uploaded for a given study, grouped by Site.
  • Monthly Document Creation Report: Documents created per month for a specific study.
  • Number of Quality Issues (by Created By): View Quality Issues grouped by Document Owner.
  • Outstanding Document Quality Issues (By Assigned To): View Quality Issues grouped by Assigned To.
  • Quality Issues by Document: Used for viewing a document’s Quality Issues (webaction).
  • Site Essential Document Completeness: View all Site Essential Documents that need to be uploaded for a given study, optionally filtered to the site level.
  • Time in Unclassified > 14 Days: Documents that have spent more than 14 days as unclassified for a specific study.
  • TMF Inspection: Inspector Activity Oversight: Identify document usage by user and study for inspections in Vault.
  • Transferred Documents (Active): Shows all documents of a study received via TMF Transfer. (For non-archived documents).
  • Transferred Documents (Archived): Shows all documents of a study received via TMF Transfer. (For Archived documents).
  • Unapproved Documents: Shows all documents that are not in the Approved state for a given Study.
  • Unclassified Documents: This report shows all documents that have not yet been classified for a given Study.
  • User Access to Study and Vault: Identify user access granted and revoked in Vault.

Dashboards

The following Clinical Basics dashboards are available:

  • TMF Overview Dashboard: To get insights into a Study’s TMF Completeness, Timeliness, and Quality.