Index per trial type
Confirm the trial type and sites, and the expected documents are created.
Trial Master File
The index is built from the trial type, for large and small studies.
The Danish GCP units' TMF/ISF index is the default view.
Confirm the trial type and sites, and the expected documents are created.
The site's ISF is managed by the PI.
A published protocol version is locked and filed in the TMF, then sent for signature.
Every upload becomes a new version with its own SHA-256 hash. The audit trail also logs every view and download.
