Vivarcus Help Center

Help Center

Vivarcus product documentation and guides: eTMF electronic trial master file and CTMS clinical operations.

eTMF HelpElectronic trial master file: study hierarchy, document workflows, EDLs & milestones, inspection readiness. CTMS HelpClinical trial management system: study startup, site management, subject tracking, monitoring & issues, operational dashboards.

FAQ

How do I request a trial?

Submit the form on the website trial page. Every applicant receives a dedicated demo environment pre-loaded with sample data relevant to their work.

What is the difference between eTMF and CTMS?

eTMF manages documents: collection, review, approval, filing, and inspection readiness of the trial master file. CTMS manages operations: studies, sites, subjects, monitoring, and issues. Both share the study hierarchy data and together cover the full trial lifecycle.

Where can I see the study hierarchy?

Open the Study Info tab. The Studies list shows all studies; open a study's detail page to drill down to study countries and study sites. See Study Hierarchy.

What is an EDL?

The EDL (Expected Document List) is the checklist of "what this TMF should contain", configured by admins via templates and automatically generated onto a study by the Plan Study action. See EDL & Expected Documents.

When are documents automatically filed?

Approved documents in steady state are automatically filed into the corresponding Master File location. The filing location is determined by the document's TMF metadata and its expected document match. See TMF Viewer.

How do I check document completeness?

Open TMF Homepage, select a study, and review completeness, timeliness, and quality issue metrics with drill-down into individual documents. See TMF Homepage.