Site Visit Documentation

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Within CTMS, users with the appropriate permissions can create and track site visits associated with a specific site. These users can also link data, such as attendees, locations, subjects, enrollment summary, and activities, to each site visit. Additionally, the system allows generation of site visit confirmation letters, site visit reports, and follow-up letters. The generated site visit documents can be viewed in the TI Viewer and routed through an approval workflow to support review, approval, or rejection.
Note:

For more information about configuring CTMS to work with Trial Interactive’s eTMF solution, please reach out to the Trial Interactive representative.

Pre-Requisite

The Clinical Research Associate (CRA) user responsible for creating and managing Site Visit Documentation in a Site must have the Site & Visit Editor permission.

Unblinded users will have the right to create unblinded site visits and related documentation, which will only be visible to other unblinded personnel.

Important

  • Any details created within a site visit type designated as Unblinded will be restricted from view by users who do not have an unblinded access permission for the Study or Site.
  • Unblinded designation on site visits is typically limited to only site visits where users want to restrict the visibility of potentially confidential restricted data (e.g., activities)
  • If there are no site visit report templates designated as Unblinded, and the visit is of an unblinded type, users will not be able to generate documents without configuration changes/updates. Those changes have to go through the change management process.
  • Unblinded site visit document will only auto-file to an unblinded eTMF.
  • The Open Label is not the same as Unblinded in Trial Interactive’s CTMS designations.