What this is, and who it is for
The Forms screen is where a study's forms are made, listed and moved from Draft to Active. Drawing a form's contents is a separate tool, the form builder, documented page by page in The form builder; this page is the task around it: create or bring in a form, set its details, open the builder, make it active.
| You need | To |
|---|---|
form.design or study.write | create, edit, activate, reopen and archive forms |
form.read | see the list and each form's page |
ai.generate | see Generate with AI |
Held by: Organization Admin, Project Manager, eCRF Designer (form.design or study.write).
Where to find it
Study → Build → Forms (in a workspace, the same list is shown read-only under Configuration). The header shows Total, Active, In progress and From Library; cards repeat them as Forms in study, Active, Draft and Imported from library. A Quick start offers Create new form, Generate with AI and Import from Library. Forms are listed by category in sections; each row shows the form's code and name, its version label and status badge, the number of fields, an event badge (Adverse event, Serious AE, Con med, Event) and a Library or AI badge when it came from there. Search forms… filters the list.
What you can do
Make a form
- New form: the dialog New form in this study asks for a code, details and (below) whether it is an event form, then Create & open builder.
- Import from Library: pick a template; it is copied as a Draft form and links back to the library (The form library and templates).
- Generate with AI: describe the form; a draft is created for you to review (AI form generation).
- Creates the form as a draft and opens the builder.
Form details
| Field | Notes |
|---|---|
| Code | Required, in capitals; unique in the study (DM, VS, AE) |
| CDISC domain tag | A label for grouping, not an SDTM or define.xml mapping. DM, MH, VS, PE, LB, EG, CM, AE, AE (serious), DS, IE, EX, PC, RS, EC. AE, AE (serious) and CM make the form an event form; EX and CM make it a dispensing form for the Pharmacy role |
| Display name | Required |
| Category | Uncategorized, Subject Data, Screening, Eligibility, Assessments, Labs, Safety, Treatment, Biomarkers, PRO, Efficacy or Quality; the list is grouped by it |
| Description | What the form captures |
| Event form | Switch on for a form a site fills in when something happens rather than when a visit falls due: an adverse event, a serious adverse event, a concomitant medication or another event. Then say what kind of event (required; an event form that does not cannot be submitted to UAT). An adverse event, serious adverse event or concomitant medication form starts with the standard fields its logs read: for an adverse event the name, description, start and end date, medications given, causality, severity and status of the event, and notes; for a medication the name, dose, unit, route, indication, start and stop dates and notes |
A version has at most one adverse event form and one serious adverse event form, and each needs the other: an adverse event that becomes serious is upgraded into the serious form. If you remove a standard field the version cannot be submitted until it is back. Details can be edited while the form is a Draft (Edit details).
Work on a form
Each row's menu offers View details (the form's page: version, description, preview, maintenance), Open builder (or Open builder (preview) when the form is not a Draft), Edit details, and the status actions: Make active, Reopen for editing, Archive draft (Versions, reopening and publishing).
Before you make it active
Open the form in the builder, look at the issues list, and preview it. Making a form active fixes its design and lets it be mapped to visits and used for data in the version (Preview and testing).
Every option
Every control of the builder, with every field type, check, formula function and logic option, is on the pages of The form builder. The older Forms reference is now an index to them.
What the system records
form.created (with its source: blank, library, AI), form.draft_saved for each save, form.transitioned for each status change, study_form.field_deprecated and study_form.field_restored with their reasons. See Audit events.
What you cannot do, and why
- Edit a form that is not a Draft, or in a version that is not in Build.
- Delete a form. A Draft form is archived: it is kept for audit and left out of normal lists.
- Reopen a form after the study has gone Live. Use an amendment.
- Have two adverse event forms, or an adverse event form without a serious one.
- Use the CDISC domain tag as a mapping. It is a label.
Compliance Q&A
Yes. A form is a Draft until it passes the design checks and is made active; the version it belongs to is tested in a UAT cycle and signed off by three people before any participant sees it; every status change and save is attributed and recorded.
Evidence: server/src/modules/study/forms (status transitions, design checks on activation)versions (UAT cycle, sign-offs)audit events form.*
Related
The form builder · Build a form: a walkthrough · Plan visits · Use the form library · eCRF Designer