Export to CDISC ODM

What ODM is, how the export is read, keys, data types, validation.

CDISC ODM (Operational Data Model) is the open XML format for exchanging and archiving clinical study data: one file holds the study structure (visits, forms, items, code lists) and the data. Most EDCs, archiving and statistics tools read it. The portal writes ODM 1.3.2, the most widely supported version.

What you can upload

Modular export: a CSV file or Excel sheet per form (DM, VS, AE…), as Rave, InForm, OpenClinica, Viedoc or SAS datasets saved as CSV give it.
Flat export: one wide table, a row per subject or per subject and visit. When columns are named FORM_ITEM (VS_SYSBP), choose the separator and the portal splits them into forms. Otherwise the table becomes one form.

How the export is read

Key columns are found automatically: subject (Subject, SUBJID, USUBJID, record_id), site (Site, SITEID, Site Number), visit (Visit, Folder, redcap_event_name) and repeat number (RecordPosition, redcap_repeat_instance), Russian names included. If one is not found, type its name in “Column names”.
Technical columns of the EDC (projectid, RecordId, save timestamps, _RAW and _INT copies) are skipped by default; the result lists them.
Each item’s type comes from its values: integer, decimal, date, date and time, text. Dates become ISO 8601 (2026-08-03) and decimal commas become dots, as ODM requires. Numbers with leading zeros (001) stay text.
When a subject has several rows of one form at a visit (AEs, medications), the item group becomes repeating.
Cyrillic names are transliterated for OIDs; the original names stay as names.

Validation

Before download the file is checked against the official CDISC ODM 1.3.2 XML schema and against the rules the schema cannot express: every reference to a visit, form and item is defined, OIDs are unique, values match their type. An invalid file is not offered; the portal shows what to fix.

Example

Modular example: an Excel workbook with sheets DM, VS and AE in Rave style, with technical columns, dates like 03.08.2026 and weights with a decimal comma. Flat example: one table with columns DM_SEX, VS_SYSBP, LB_HGB. Press an example button, look at the structure and download the ODM.

Sources

CDISC ODM on the CDISC site; the ODM 1.3.2 schema comes from the official CDISC repository (MIT licence).

Nothing is stored. The export is read in memory; the audit trail keeps the number of forms, subjects and values and the SHA-256 of the file given out. Code lists (codes and decodes) cannot be rebuilt from an export: take them from the specification if you need them.