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Trial Master File

Your TMF knows what is missing.

The index is built from the trial type, for large and small studies.

Built on the index that sites already use.

The Danish GCP units' TMF/ISF index is the default view.

Index per trial type

Confirm the trial type and sites, and the expected documents are created.

Study, country and site

The site's ISF is managed by the PI.

The protocol arrives by itself

A published protocol version is locked and filed in the TMF, then sent for signature.

Nothing is overwritten.

Every upload becomes a new version with its own SHA-256 hash. The audit trail also logs every view and download.

  • Cannot be switched off
  • Export as CSV or JSON

Works with

See how your TMF can be set up.

Joakim Bo Kunkel

Director, MD, PhD

+45 60 60 17 28