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 initializes included Artifacts as Draft and excluded Artifacts as Out of scope. Pending content or a Current filing moves an Artifact In scope; removing its last active content returns it to Draft.

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 the source content. When a Document already has one unambiguous Artifact and target, File in TMF files it directly.

• Trial-wide content applies across the trial.
• Country content uses countries configured in Trial Summary.
• Site content only offers governed Trial Sites beneath their country.

TrialStack asks for File under only when more than one applicable target exists. It derives the EMS object level and country/site identities from that governed relationship. New filings are always Current; use the targeted Replace files, Mark superseded, or Mark obsolete actions to create a new filing version.

A draft source remains pending and cannot create a filing record. Complete the Document or Media version first. 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.

Pending draft content can therefore appear as a suggestion while the Artifact still shows missing guidance.

Create an eTMF export

The Exports tab builds eTMF-EMS transfer packages from the governed TMF state. The default is a Completed package containing all eligible Current filings. Package scope is an optional per-export restriction; leaving country, site, and Artifact filters blank includes every available value.

Each export is retained with its request state, source snapshot, package checksum, validation summary, and download. EMS 1.0.2, TMF RM 3.3.1, and the TrialStack organization transfer-source identity are fixed by the export profile rather than a saved agreement.

An eTMF export is a complete eTMF-EMS 1.0.2 ZIP package, not an upload or downstream ingestion flow. TrialStack serializes the required batch, object, and file fields; includes the immutable source bytes; validates exchange.xml against the pinned XSD; reopens the ZIP; and verifies every content path, size, and checksum. The retained evidence claim is therefore XSD-valid and content-integrity verified. It does not claim downstream ingestion or inspection readiness.

TrialStack’s exchange profile deliberately excludes optional EMS enrichments such as signatures, EMS audit records, people and organization metadata, language and translation flags, retention and expiry dates, descriptions, and custom metadata. Those enrichments, operational filing, records management, and inspection-ready operation belong to the downstream eTMF system.

For recurring transfers, TrialStack compares the stable filing ID, filing version, and EMS object-version state with the selected baseline. A previously exported current filing must first receive a new Superseded or Obsolete version before it can be deleted or removed from the recurring scope.

Ownership boundaries

Surface	Owns
Trial Master File	Hierarchy templates, Artifact applicability, filing scope, readiness, package construction, 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.