eTMF: The Evidence Archive
The eTMF exists to collect, organise, and retain essential records that prove regulatory compliance. It’s reactive by nature, things happen in the trial, documents are generated, and the eTMF stores them as evidence. When your CRA finishes their site visit, all those records they collected and generated? They file them in the eTMF.
CTMS: The Operations Engine
The CTMS exists to help you plan, execute, and monitor trial activities. It’s proactive, helping you coordinate what needs to happen next, tracking progress, and flagging when things go off track. When your CRA needs to schedule monitoring visits across 50 sites, they use the CTMS.
The Data They Contain
eTMF holds essential documents: protocols, regulatory approvals, ethics committee documents, investigator CVs, monitoring visit reports, and safety documents. All organised according to the TMF Reference Model (soon to be TMF Standard Model V1).
CTMS holds operational information: site recruitment timelines, patient enrolment numbers, visit schedules, budget tracking, milestone dates, and risk indicators. This is living, breathing data that changes constantly as the trial progresses.
