What this is, and who it is for
The Form Library is the organization's shelf of reusable form designs, called templates: a standard Demographics, a standard Vital Signs, a standard Adverse Event. Build a form once, keep it in the library, and copy it into any study. It belongs to the organization, not to a study, and a template has no status: it is a repository, not a controlled design. Whatever is copied into a study is then controlled as part of that study's version.
Where to find it
Form Library in the main menu (for anyone who holds form.read or form.design). Reading templates is open to any signed-in person, because a template holds no participant data; creating, changing and removing them needs library.write.
Held by: Organization Admin, eCRF Designer (library.write).
The page has five tabs: Form Templates, Variables Library, Visit Templates, Codelists and Saved bundles. Only Form Templates is built. The Variables Library, Visit Templates and Codelists tabs say Coming soon, and Saved bundles shows an empty description. Their counts on the page are zero.
What you can do
On the library page
- New form template: code, display name, description, category, CDISC domain tag, therapeutic area and phase, then open it in the builder.
- Add from study: pick a study, then tick forms to promote to the library. A form whose code is already in the library is skipped.
- Search by code, name, category or tag, and Group by therapeutic area. The table shows code, name, category, phase, tags and field count.
- For a template: Open in builder, Edit details, Use in study, Remove.
Use a template in a study
- Use in study (library page): pick a study and the template is copied into that study as a new Draft form in its version in Build, and you are taken to the study's Forms list. The study keeps its own working copy, which can be edited independently, and a link back to the library entry is kept. A form already imported from that template is not imported twice (is already in this study). If the template is an event form, you say what kind of event it is, and an adverse event, serious adverse event or concomitant medication form is given the standard fields it lacks.
- Import (in the builder's toolbar): add a template's fields to the form you are editing. They land as a fresh copy with new identifiers, variables and logic preserved, appended to the end of the form, in a single undo step. This is for reusing part of a form; use Use in study for a whole one.
- On the study's Forms page, Import from Library does the whole-form copy from inside the study.
Every option
A form template
| Field | Meaning |
|---|---|
| Code | Capitals, unique in the library (DM, VS, AE) |
| Display name | What people read |
| Category | Uncategorized, Subject Data, Screening, Eligibility, Assessments, Labs, Safety, Treatment, Biomarkers, PRO, Efficacy, Quality |
| CDISC domain tag | A grouping label: DM, MH, VS, PE, LB, EG, CM, AE, AE (serious), DS, IE, EX, PC, RS, EC. A label for grouping, not an SDTM or define.xml mapping. AE, AE (serious) and CM also make the form an event form (and set its kind), and EX and CM mark it as a dispensing form the Pharmacy role may fill in |
| Therapeutic area, Phase | Used to group templates and to ground AI generation |
| Description | What the form captures |
| Tags | Free labels, shown in the table |
What is copied
The whole form document: its fields, checks, logic, formulas, tables and layout, with the code, name, description, category, domain and event setting. Nothing is copied back: a change in the study does not change the template, and changing the template later does not change forms already in studies.
Promote a study form to a template
Add from study copies a study's form into the library as a new template, skipping any whose code is already there.
- Copies them as templates.
What the system records
Creating, changing and archiving a template is library_form.changed in the organization's audit trail. Copying a template into a study is the study's own form creation (form.created, source library), and the study form keeps the template's identifier so the origin is known.
What you cannot do, and why
- Keep a template in step with the forms made from it. The copy is independent by design, so a study's design cannot change under it.
- Use a template in a study whose design is frozen. The copy goes into the version in Build; a study with none in Build must start an amendment first.
- Keep variables, visit schedules or codelists in the library. Those tabs are not built; see Not built yet.
- Delete a template. Remove archives it; it leaves the list but is kept.
Compliance Q&A
Yes. A template is copied into a study as that study's own working copy, which then goes through the study's UAT and sign-off. Later changes to the template never reach forms already in studies. The link back to the template is kept for traceability.
Evidence: client modules/forms/components/UseInStudyDialog.tsx (document copiedlink preserved)server library module
Related
Overview · AI form generation · Design forms · Use the form library · Roles and permissions