eTMF Completeness

eTMF Completeness is a milestone indicator of a clinical study process based on the status of the documents required for the study. The eTMF Completeness view lists the collected, missed, and placeholder documents required to complete a study along with the milestones linked with each document and its placeholder. Therefore, through this module, the Administrator can understand the quality and health of the TMF thereby enabling the Administrator to define controls to set placeholders required to collect documents to complete the clinical trial.

Controls can be set in the form of Milestones that are linked at each stage of eTMF completeness to measure the progress percent of documents collected at each stage of the eTMF completeness. For example, the Administrator can set up a milestone for a Site Visit event to include documents for a Confirmation letter sent by the CRA for a site visit, a Site Visit Report, and Follow-up Letter. Each of these documents and their types which are defined in the eTMF room can be linked to a milestone, milestone events defined for the same, and placeholders set up in the eTMF. To be able to set up the complete process and make tracking of eTMF Completeness seamless, the Administrator needs set up:

  1. The eTMF Completeness metrics from the eTMF health in the room settings
  2. The Milestones for complete integration of documents
  3. Creation of document types and their linking to milestones
  4. Creation of Visit types to generate Site Reports
Important:
  • For more details on eTMF Health Settings, proceed to section eTMF Health Settings
  • For more details on CRA Visit types, proceed to section CRA Visit Types
  • For more details on the creation of milestones proceed to section Milestones.
  • For more details to link milestones with document types to track eTMF completeness proceed to section Include Phases/Milestones.
  • For more details on creating milestone events/history proceed to section Milestones.