What this is, and who it is for
How a form's design gets in (from the library, from AI, by copying) and out (as a data dictionary, a design document or ODM-XML, or on paper). The design that comes out is what a reviewer, a validation team, a statistician or an inspector reads to know what each field is, what it allows and which version was signed. Moving participants' data in and out is a different thing: see Export data and the Exports reference.
Where to find it
- In: the builder's Import button and AI Assist; the Forms list's Import from Library and Generate with AI; the Library page (The form library and templates).
- Out: Study → Exports at the study level (outside a workspace), choosing Design and a version. You need
export.readto see it andexport.runto ask for one; the format needs the organization'sexports.csv(CSV, Excel) orexports.cdisc(ODM-XML) switch on. Print view in the builder's preview prints a single form.
Held by: Organization Admin, Project Manager, Data Manager, Regulatory Manager (export.run).
What you can do
Bring a design in
| Way | What arrives |
|---|---|
| Use a template in a study | A whole library form, as a new Draft form |
| Import in the builder | A template's fields, appended to the form you are editing, as one undo step |
| AI Assist | A drafted form, appended in one undo step (AI form generation) |
| Duplicate a field or section | A copy with new identifiers and renumbered variables |
| Amendment | Every form of the Live version is copied into the new version as a Draft working copy |
| Add from study (library) | Takes a study form out to the library |
There is no import of a design from a file: no JSON, ODM-XML or spreadsheet can be loaded into the builder. Bring a design in by one of the ways above and edit it.
Take a design out
Ask for a design export of a version, in one of four formats:
| Format | File | Holds |
|---|---|---|
| CDISC ODM-XML | .xml | The design's metadata: forms, items, code lists, units, annotations, ranges |
| JSON | .json | The trialion-design document: study, version and snapshot hash, the visit schedule, every form with its fields and checks, the visit–form bindings and the rules |
| CSV data dictionary | .csv | One row for each field |
| Excel data dictionary | .xlsx | The same rows in a workbook |
Every option
The data dictionary
One row for each field, with these columns: study, version, snapshot SHA-256, form, form name, section, order, table, variable, label, type, required, unit, choices (value=label [coded value], separated by semicolons), min, max, decimal places, min length, max length, pattern, normal range, normal ranges by value (for example female: 12 to 16), min date, max date, calculated from (the formula), sdv, annotation and state (for example deprecated).
Which design
- A frozen version (in UAT or later) is exported from its snapshot, and every form of the export carries the version number and the snapshot's content hash, so a copy given to an inspector can be matched to the design the sign-offs refer to.
- A draft in Build may be exported at a named revision: the version must be in Build and the revision must be its head now (otherwise the request is refused as stale). The file is labelled DRAFT with the revision and a hash of the design as compiled; it is not a signed version, and the job fails if the draft moves on before it runs.
On paper
In the preview choose Print view for a clean one-page layout of one form, then print from the browser. There is no PDF export of a form or a casebook (Not built yet).
What the system records
Asking for an export, its completion, a failure and each download are audit events (export.requested, export.completed, export.failed, export.downloaded) with the person, the time and what was asked. The file's SHA-256 and size are kept with the job. Bringing a design in is the study's own form creation or save, audited as such.
What you cannot do, and why
- Load a design from a file. A form enters the system only by being drawn, copied from the library or an earlier version, or drafted by the assistant, so every field has been through the builder's checks.
- Export a design the format switch forbids. A request for a format whose switch is off is refused naming the feature.
- Treat a draft export as the signed design. It is labelled DRAFT on purpose.
- Export SAS or PDF, or a signed export. Not built.
Compliance Q&A
Yes. A design export of a frozen version is made from its snapshot and carries the version number and the snapshot's SHA-256, which is the hash the three sign-offs refer to. It can be produced as a data dictionary (CSV, Excel), a design document (JSON) and ODM-XML.
Limits: the ODM-XML was not validated against the CDISC schema, and there is no define.xml or annotated CRF (Not built yet).
Evidence: server/src/modules/study/exports/domain/design-dictionary.ts (study, version and snapshot hash in every form)versions snapshot hash bound to the sign-offs
Related
Exports reference · Export data · The form library and templates · Versions, reopening and publishing