What this is, and who it is for
An export is a file of a study's data or of its design, made in the background and kept for a week. There are two kinds: a data export of a workspace (Live or UAT) and a design export of a version. This page is the task; every format, dataset, part and rule is on the Exports reference.
| You need | To |
|---|---|
export.run (data manager, regulatory manager, project manager, Organization Admin) | Ask for an export |
export.read (also sponsor roles and the auditor) | See and download what was produced |
Held by: Organization Admin, Project Manager, Data Manager, Regulatory Manager (export.run).
Site staff hold no export right. A person confined to sites exports only those sites. The organization must have the format's switch on (exports.csv for CSV and Excel, exports.cdisc for ODM-XML).
Where to find it
- Data: inside a workspace, Exports → New export. The same dialog also opens from Export this site (a site), Export this participant (a participant's Reports, with signatures and the audit trail unticked) and Export beside the AE and SAE logs.
- Design: Study → Exports (at the study level), the Design exports panel: choose a version and a form of the export. Build → Export design exports the draft as it stands.
What you can do
Export data
In New export (Export data) answer three things:
- What to export: The whole study (every participant of the workspace), Chosen sites (tick them), or Chosen participants (search by participant ID and pick). A site or participant that is not the study's is refused by name. One request names up to 500 sites or participants.
- Which parts: Participants and status, Form data (one row for each captured value, with variable, table row and column), Queries, Signatures (who signed what, when and what it meant), Events (AE, SAE, medications) (four tables) and Audit trail. Participants, form data, queries and events are ticked; signatures and the audit trail are asked for, not given. Include events removed as mistakes lists events that were removed. The events part is included only if you hold
clinical.event.readacross the study, the queries part only withclinical.query.read, and the audit trail part only withaudit.read; the participants and form data parts need only the right to export. - Format: Excel workbook (the default; an About sheet says what the file is of and holds), CSV files (zip) (a CSV for each part and a
manifest.jsonwith the row counts) or ODM-XML (the form data of the participants, with signatures and the audit trail as the standard's elements when ticked; the other parts are not part of an ODM-XML file).
Choose Export. A toast says it was requested. The export is queued, then running, then ready; it appears in the history (who asked, what, when) and can be downloaded until it expires after seven days. The scope and parts are in the audit entry of the request.
- Queues the export; the worker produces it.
- Opens the export dialog for this participant.
- Print the page or save it as a PDF.
Export the design
The Design exports panel (A version's frozen design as JSON, a CSV or Excel data dictionary, or CDISC ODM-XML: forms, fields, checks and the visit schedule, no subject data. Every file carries the same snapshot hash.) lists, for the chosen version and form, the files made: JSON (forms, fields, checks, visit schedule and rules), CSV and Excel data dictionaries (one row for each field and table column) and CDISC ODM-XML (the metadata). All forms asks for the four at once. Each file is named after the study and version and carries the design snapshot hash, with a file hash; you can copy either. A version still in Build has nothing frozen to export; Export design in Build makes a labelled DRAFT copy at the revision on the page (Importing and exporting a design).
- Starts the export of the chosen version's design.
Every option
Which format for what
- CDISC ODM-XML for analysis and submission preparation: the standard interchange format, with the study structure and the data.
- Excel for review and reconciliation; CSV for a quick pull of one dataset or a zip of parts.
- SAS and PDF, and signed exports, are refused with a clear message rather than producing a mislabeled file.
Environment
A UAT export holds test data only and a Live export production data only; they are never mixed.
What the system records
export.requested (what, parts, format, scope), export.completed (with the file's SHA-256 and size), export.failed and export.downloaded, each with the person and the time. Exports remain possible after the database is locked. See Audit events.
What you cannot do, and why
- Export the events, queries or audit trail of a study you may not read. Those three parts follow your read rights, and a person confined to sites exports only their sites. The participants and form-data parts need only
export.run: a role that holds it withoutsubject.read(the Regulatory Manager) can still export them, so giveexport.runonly to people who may see the data. - Mix test and production data.
- Download after seven days. Ask again.
- Export a format the organization has switched off.
- Get a signed, SAS or PDF export.
Compliance Q&A
Yes. See Exports reference: three formats, the signatures and audit trail as parts, an About sheet or manifest saying who asked and what the file is of, and a hash on every design file.
Limits: the ODM-XML was not validated against the CDISC schema; there is no PDF or define.xml.
Evidence: server/src/modules/study/exportsexports produced in the simulation of 20 Oct 2026 (Excel with 9 sheets, CSV package of 9 files and a manifest, ODM-XML 1.3.2)
Related
Exports reference · Importing and exporting a design · Close and lock a study · Review the audit trail · Data Manager