What this is, and who it is for
An export is a file of a study's data or of its design, produced in the background and kept for a week. This page is the reference: every format, dataset, part and rule. The steps are on Export data.
Where to find it
Study → Exports in the left menu of a workspace (UAT or Live) for data exports; Study → Exports at the study level for design exports of a version. Without export.read the entry is not offered; without export.run there is no New export button, only the history.
Held by: Organization Admin, Project Manager, Data Manager, Regulatory Manager (export.run).
Held by: Organization Admin, Project Manager, Data Manager, Sponsor Manager, Sponsor Supply Manager, Auditor, Regulatory Manager (export.read).
Site staff have no export. An export of a study that spans sites is not confined to one site; a person confined to sites can export only the sites they work at.
What you can do
Request an export (it is queued), watch its status, download it when it is ready, and see the history of requests with who made them. A request names a format, a dataset, what the file is of (the whole workspace, some sites or some participants) and, for a package, which parts.
Every option
Formats
| Format | File | Datasets it produces | Built? |
|---|---|---|---|
| CSV | .csv; a package is a .zip of one CSV per part | subjects, queries, signatures, data (the clinical data in long form), ae_log, sae_log, package | Yes |
| Excel | .xlsx | full (the study's workbook), ae_log, sae_log on a sheet of their own, package (a sheet per part) | Yes |
CDISC ODM-XML (odm_xml) | .xml | full (the whole study, hierarchically), package (the form data of the participants chosen) | Yes |
| SAS | No. A request is refused with a clear message rather than producing a mislabeled file | ||
| No |
Design exports (a version's design, not participants' data) come as ODM-XML, JSON, a CSV data dictionary or an Excel data dictionary.
Scope and parts
Every request says what the file is of (the whole workspace, siteIds or subjectIds) and, for package, which parts it holds. Both are kept with the job and stated in the audit entry of the request.
| Part | Excel sheet | CSV file in the zip | In ODM-XML |
|---|---|---|---|
| Participants and status | Participants | participants.csv | |
| Form data | Form data | form-data.csv | the clinical data |
| Queries | Queries | queries.csv | |
| Signatures | Signatures | signatures.csv | Signature elements |
| Events | AE log, SAE log, Medications, Other events | ae-log.csv, sae-log.csv, medications.csv, other-events.csv | |
| Audit trail | Audit trail | audit-trail.csv | AuditRecord elements |
- An ODM-XML file must include the form data; parts it cannot hold are refused by name.
- The events part needs
clinical.event.readacross the whole study; the audit trail part needsaudit.read. Without them the request is refused (403). - An id of a site or participant that is not the study's (or not this workspace's) is refused (422) by name.
- An Excel workbook has an About sheet, and a package zip has
manifest.json: both say what the file is of, the parts, who asked and when. The About sheet and the manifest also name the participant key: a participant has a subject number only once enrolled, so a participant who was only screened, or who screen failed, is identified by the screening id.
Design exports of a draft
A design export may be of a draft in Build, at a revision: the version must be in Build and the revision must be its head now (otherwise 409). The file is labelled DRAFT with the revision and the content hash, and is not a signed version; the job fails if the draft moves on before it runs. A frozen design is exported from its snapshot, which carries the snapshot's hash so the file can be matched to the version that was tested and signed.
Lifecycle
| From | Can move to |
|---|---|
| queued | running, failed |
| running | ready, failed |
| ready | expired |
| failed | (none: final) |
| expired | (none: final) |
Exports are produced in the background, never in the request. A ready export expires seven days after it is produced; an expired file is no longer served.
Environment
An export carries the environment it was produced in. A UAT export holds test data only and a Live export holds production data only; they are never mixed.
Feature switches
The platform console has two export switches per organization: exports.csv (CSV and Excel) and exports.cdisc (ODM-XML). Both are enforced when a request is made, by the format it names, for data exports and design exports alike: a request for a format whose switch is off is refused with 403 naming the feature, ahead of the permission check. A file that already exists stays downloadable, because reading is not gated. See Feature switches.
What the system records
Four events: export.requested, export.completed, export.failed and export.downloaded, each with the person, the time and the request's scope and parts. The file's SHA-256 and size are recorded with it. No study state stops an export being requested, so exports remain possible after the database is locked.
What you cannot do, and why
- Export SAS or PDF, or a signed export: not built, and refused rather than produced under a false label.
- Export the events, queries or audit trail of a study you may not read. Those parts follow the reader's rights, and a person confined to sites exports only those sites. The participants and form-data parts need only
export.run. - Mix test and production data. A file is of one workspace.
- Download after seven days. Ask again; the data has not moved.
- Export when your organization's switch is off for that format.
Which to use
- CDISC ODM-XML for analysis hand-over and submission preparation: the standard interchange format, carrying the study structure with the data.
- Excel for review and reconciliation.
- CSV for a quick pull of one dataset, or a zip of parts.
Compliance Q&A
Yes, in three standard formats, with the signatures and the audit trail as parts, and with an About sheet or manifest saying who asked, what the file is of and when. The counts in the files were compared with the database in the simulation.
Limits: the ODM-XML was not validated against the CDISC schema, and there is no PDF or print-ready casebook export; a casebook can be printed from its screen.
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 with 331 items and 331 audit records for 6 participants)
No. SAS and PDF formats are not built, and neither is a signed export. Use CSV or ODM-XML for hand-over.
Related
Export data · Close and lock a study · Feature switches · Audit events