Export

Why it matters

flowchart LR
    Record[Governed record] --> Export[Export]
    Export --> Share[Shared output]

Export explains how TrialStack turns governed records or workflow output into something that can be shared, reviewed elsewhere, or delivered downstream.

How it works

flowchart LR
    Request[Export request] --> Output[Output artifact]
    Output --> Source[Trace back to source]

Exports run through shared request flows so teams can track the request, understand what was produced, and keep the result tied back to the source record or workflow.

Trial standards exports also retain a manifest with the source trial version and design transaction, selected profile and format, projection options, standards and validator versions, validation summary, and artifact checksum. This makes a completed export reproducible and keeps later trial edits distinct from the snapshot that produced the file.

Export execution status describes whether TrialStack produced the artifact. Validation and conformance describe the artifact itself. A standards export can therefore be Completed with findings while its details drawer retains unresolved mapping, semantic, projection, or format findings, or a nonconformant USDM CORE result. Failed is reserved for serialization, rendering, mandatory-validator, USDM JSON Schema, or ODM XSD failures that prevent a trustworthy artifact.

Completed textual standards exports can be inspected before download from the Preview tab. JSON is shown as an interactive tree, ODM XML as syntax-highlighted source, and ICH M11 DOCX/PDF review content as the same rendered protocol prose used to build the downloadable reviewer artifact.

Findings retain the governed source page that owns the correction. For example, intervention terminology and administration findings return to Trial Interventions, while incomplete or ambiguous estimand relationships return to Trial Summary, where those relationships are authored. Schedule validation derives the reference visit from the USDM timeline relationship, so the preview and findings reflect the exported standard structure rather than internal-only visit flags.

Terminology projection is target-aware. TrialStack persists the stable authored value and its authoring provenance, then deterministically resolves the selected export target from pinned, field-specific codelists. It does not reuse an authoring code as a USDM or M11 target code when the exact target member is absent. The retained evidence identifies the projection rule and terminology release so later exports do not reinterpret historical artifacts.

Standards export creation is deliberately narrower than the internal projection catalog. The UI offers USDM 4.0 JSON, ODM 2.0 study-definition XML, the SDTM Trial Design delivery package, and a clearly labelled ICH M11 protocol projection for review. M11 review files contain protocol content only; the source-locked 575-component dispositions, exact authored bindings, internal rule results, and explicit gaps remain in export metadata. These are TrialStack technical-specification export checks, not official ICH conformance. Experimental schedule projections and the EDC ODM handoff workflow are not presented as operational exports.

PDF and Word exports for document and evidence-pack content apply final-document styling: template placeholders are restyled into ordinary black text, non-citation brackets/braces/chevrons are removed, and protocol-style headings use the final export typeface and hierarchy. Submission-oriented exports also use one-inch Letter margins, centered Page x of y pagination, and undecorated single-line table grids so the PDF rendition stays aligned with the source artifact.

When to use it

flowchart TD
    Need[Need deliverable output] --> Export[Export]
    Edit[Need live editing] --> Stay[Stay in product]

This concept matters when the team needs a structured output artifact rather than another live edit inside the product.

What to watch for

flowchart LR
    Export[Export] --> Context[Keep context]
    Context --> Review[Review downstream]

Export should preserve context and traceability. It should not become a hidden side path where important output leaves the governed workflow without review.

For standards output, inspect the manifest and validation result together. A conformance result describes the exported snapshot against the named validator and pinned ruleset; it is not a general claim that the study or protocol is compliant.