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.

The creation dialog separates the governed profile from its available formats. Choose the profile first, then choose its JSON, XML, spreadsheet, document, PDF, package, review, or handoff representation. Changes stay in the dialog until Create is selected. Undo restores the configuration that was present when the dialog opened, and Cancel closes without retaining those changes.

The eSAP profile pins the exact Trial and Trial Statistical versions plus the immutable TrialStack eSAP profile, then renders JSON, XLSX, DOCX, and PDF from one canonical specification. Every format retains the same semantic checksum and coverage findings. Export history compares those retained pins with current versions at read time; a stale badge never changes the historical artifact. The checksum-pinned TransCelerate SAP Core TEE is advisory structural evidence for the fixed profile, not a user-selected template or a normative conformance target.

The SDTM mapping profile starts in the Exports configuration drawer. A reviewer can create a versioned mapping specification from the current canonical acquisition package, review individual rows, inspect findings and source pins, refresh changed sources, and restore an earlier version. Review JSON and Excel contain the same canonical semantics. Handoff JSON additionally requires an active connected system whose exact governed version declares the SDTM mapping execution capability.

The neutral trialstack-neutral/1.0 handoff retains separate acquisition-source, specification-semantic, artifact-byte, and envelope checksums. It includes the complete specification, standards and source pins, lineage, findings, target identity, and external validation expectations. It never contains participant records, transformation programs, credentials, vendor expressions, or callback endpoints.

The ADaM build profile uses the same neutral adapter contract. Review JSON, Excel, and draft Define-XML remain available for historical and current Analysis Specification versions. Handoff JSON is available only when the exact version has current server-owned readiness evidence and an active connected system declares adam_build_execution. The downloadable JSON remains the canonical Analysis Specification; the retained handoff envelope adds the exact nested SDTM mapping version, expected inputs, planned outputs, target-neutral lineage, findings, validation expectations, exact relationship/system versions, and four independent checksums. Participant data, transformation programs, populated ADaM datasets, operational validation, connection configuration, secrets, and callbacks remain external.

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 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, form-aware generic ODM, a form-free Viedoc workflow scaffold, a Viedoc design with pinned Forms, deterministic REDCap packages, the SDTM Trial Design delivery package, and one ICH M11 CeSHarP-aligned electronic protocol specification rendered as JSON, XLSX, DOCX, or PDF. Both Viedoc targets use ODM 1.3.1 + SDM-XML 1.0; the distinct choices make their scope visible before export. Unsupported edit checks, calculations, role permissions, vendor functions, and operational RTSM remain explicit findings. M11 JSON and XLSX retain the structured TrialStack specification and its source-locked 575-component evidence. DOCX and PDF contain reviewer-facing protocol content without technical inventories. The JSON schema and checks are TrialStack artifacts, not an official ICH serialization or conformance result. Experimental schedule projections, M11 XML/CSV, and the historical EDC ODM handoff wrapper 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 trial or protocol is compliant.

Archive exports and choose a format

Completed and failed exports can be archived from the exports list. Archived exports remain available in the Archived tab and can be unarchived. Archiving preserves the export result, retained file, and evidence. Archiving or restoring a grouped card updates all its formats together; if any format cannot be updated, the entire action is rolled back. Trial export archive and restore events appear in the Exports audit history.

When retained files contain the same output in different formats, one entry provides an Export menu for choosing the file type. Different content versions, repeated exports in the same format, and distinct outputs remain separate. The M11 protocol outline can offer PDF and DOCX together; its review workbook and JSON specification remain distinct outputs.