Trial Master File

Govern the filing plan

The Trial Master File workspace turns the TMF Reference Model into a trial-specific filing plan. A hierarchy template establishes the starting set of Zones, Sections, and Artifacts. Reviewers can then mark each Artifact as applicable, not applicable, or undetermined with a recorded change justification.

Country and Site are filing dimensions, not extra hierarchy nodes. The hierarchy therefore remains recognizable while the same Artifact can receive content at trial-wide, country, or site scope.

flowchart LR
    Template[Hierarchy template] --> Zone[Zone]
    Zone --> Section[Section]
    Section --> Artifact[Artifact]
    Artifact --> Trial[Trial-wide filing]
    Artifact --> Country[Country filing]
    Artifact --> Site[Site filing]

Add governed content

Use Add content from the hierarchy or an Artifact detail drawer. One filing targets one Artifact and one scope. Select an immutable Document version or Media version; TrialStack does not copy or replace the source content.

• Trial-wide content applies across the trial.
• Country content uses countries configured in Trial Summary.
• Site content requires a country and only offers connected sites in that country.

A draft source remains a draft filing. It is visible in filed content, but it does not satisfy readiness until an immutable non-draft source version is filed. This prevents a placeholder or work-in-progress version from clearing a required filing level.

Review readiness

Applicable Artifacts show missing required filing levels directly in the hierarchy and Artifact drawer. Counts bubble up to their Section and Zone so reviewers can find unresolved work without changing the reference hierarchy.

A visible file count and readiness are related but different:

• the file count reports filed records;
• readiness reports whether the required trial-wide, country, and site levels are satisfied by eligible source versions.

An Artifact can therefore contain a draft filing while still showing missing guidance.

Create an eTMF export

The Exports tab creates eTMF-EMS transfer packages from the governed TMF state. Save a configuration for stable package policy, then choose the scope for a specific export. Leaving optional country, site, or Artifact filters blank includes every available value in that dimension.

Each export is retained in the eTMF export list with its request state and package identity. Export configurations and individual export requests are separate on purpose: the configuration defines reusable transfer policy, while the export selects the scope for one package.

An eTMF export is a transfer package, not a binary upload flow or a protocol-data standards export. The package carries the governed hierarchy, filings, source-version references, scope, metadata, and audit evidence needed for an eTMF-EMS exchange.

Ownership boundaries

Surface	Owns
Trial Master File	Hierarchy templates, Artifact applicability, filing scope, readiness, export agreements, and eTMF export history
Documents	Authored document content and immutable document versions
Media	Uploaded bytes, extracted content, and immutable media versions
Trial Summary	Trial countries used by country and site filing
Sites	Connected trial sites and their country assignment

Keeping these responsibilities separate lets one immutable source version support governed filings without duplicating content or turning filing dimensions into hierarchy structure.