eTMF Health Settings

To configure the eTMF Health Settings, follow the steps below:
  1. Enable or disable the ‘Check Study-Site Status for eTMF Health’ option. When enabled, documents will be considered as required documents only when the Study Site has reached the Status configured in the Document Type profile.
  2. Enable or disable the following under the ‘A document submitted to the room should be considered collected for eTMF Health’ section and click Save.
    • As soon as the document is submitted to the room: This setting causes the room to mark a placeholder as successfully fulfilled immediately after a document with the corresponding metadata is uploaded.
    • When the document’s QC review is completed: This setting ensures that missing document placeholders can only be fulfilled by documents designated as ‘Final’ through the room’s QC Workflow.
    • Exclude the sites with the following status from the eTMF Health: This setting ensures that document requirements for sites with the selected status are excluded from the room’s eTMF health calculations.
    • Include recommended (non-required) documents: This setting ensures that the recommended (non-required) documents are included in the eTMF health.