Functionality / Operations FAQs

What is the workaround if sites are added in CTMS before the eTMF room is built?

To ensure those sites appear in the eTMF, follow these steps:

  1. In CTMS, update the site status from Selected to Planned.
  2. Wait a few minutes to allow the integration to process.
  3. Switch the site status back to Selected.
  4. Verify that the eTMF reflects the updated site entries.

Why are Site Visit Documents generated from a CTMS Collaborate Room (CCR) not auto-filing into the linked eTMF as Final, despite being finalized and signed in the CCR?

Site Visit Documents finalized and signed in the CCR are expected to auto-file into the linked eTMF with a status of Final, bypassing Indexing and Review workflows. The current behavior—where documents are instead available for Indexing and Review—indicates a defect and does not align with the intended functionality.