Create a study

A study is the top-level container for all the work: the design (visits and forms), sites, subjects and data all live under it. Study creation and all the basic design work run out of the box — no modules are required.

StudySiteSubjectVisitFormField

What sits under what: study → sites → subjects → their visits, forms and data fields.

Who and when

Administrator or Data manager — whoever holds the “create a study” permission (study.create) at the tenant level. In the role templates this permission belongs to the tenant administrator; the study is then built by the study designer (Study Builder) or the data manager.

The task comes up once per study — at the very start, before the design is built.

Before you start

• You hold study.create — otherwise the New study button is not shown on the Studies screen.
• You know the study code and the full title from the protocol.
• If the design is already prepared (an organisation template or a JSON package from another system), keep it at hand: the study can be created together with its design.

Steps

0:000:00

Creating a study — code, title and an instant design draft.

1. Open the Studies section and click New study.

2. Choose how to create it — a tab of the dialog:

   • Manual — an empty study; you build the design yourself;
   • From template — the design is built from the chosen study template; the title and phase are taken from the template, the code is yours to set;
   • From JSON — the study together with its design from a JSON package (see Import a design from a file).

3. Fill in the card:

   • Study code — a short working identifier (for example, X7-042). Sites will see it, it goes into exports, and lists are searched by it.
   • Study title — the full title from the protocol.
   • Phase — optional: I, I/II, II, II/III, III, IV, “Not applicable” or “Not specified”.

4. Click Create (for a template — Create from template). The system opens the new study’s Overview with the Path to launch guide.

Delete a draft you don’t need

A test run or a study created by mistake can be deleted so it doesn’t clutter the list.

1. In the Studies list, open the ⋯ menu in the study’s row and choose Delete draft….

2. Enter the Reason for deletion — the operation won’t run without it — and click Delete.

You need study.delete (in the role templates — the tenant administrator and the study designer). Only a study in the Draft status can be deleted.

Restore a deleted study

In the Studies list header, open the More menu and turn on Show deleted, then choose Restore… in the study’s row, enter a reason and confirm. The study returns to Draft and continues to be built from where it was left.

What happens

• The study appears in the Draft status, and a design draft (version v1.0) is created automatically alongside it — empty, or already filled from the template/package.
• The Overview screen shows the Path to launch guide: build the forms and visits → publish the design → add a site → test run (optional) → open enrollment.
• You cannot enroll subjects or enter data yet: the Add subject button stays disabled with a hint about what’s missing — first the design must be published and the study launched.
• Deleting a draft is a soft delete: the study moves to Deleted, disappears from lists and is read-only. The design, data and audit trail are kept in full — including the deletion itself with its reason.

If it doesn’t work

• No “New study” button — you don’t hold study.create on the tenant. Ask an administrator.
• “Create” is disabled — the code and title are not filled in (for a template — no template is selected or no code is set).
• “Could not create the study”: a study with this code already exists (in “From JSON” mode — “This code is already taken”) — study codes are unique within a tenant; choose another.
• No “Delete draft…” in the row menu — you don’t hold study.delete on that study, or the study is no longer a draft. A launched study cannot be deleted: it goes through the closing path — end of enrollment, closure, database lock, archive.

Next

Build forms in the CRF builderThe draft's forms, fields and codelists.

Build the visit scheduleVisits, windows and which forms go on which visit.

Import a design from a fileA ready design — as a file following the template.

Publish a version and launchReview, publication, sites, UAT and go-live.

More details

Study statuses

A study has its own status axis: which stage of life the study as a whole is at. It does not depend on design versions or on data locks. Every transition is performed manually (permission study.lifecycle.change) and is recorded in the audit trail.

1. Draft
   • launch without UATActive
   • delete the draftDeleted
   start UAT
2. UATgo-live
3. Activeclose enrollment
4. Enrollment closedclose
5. Closedarchive
6. Archived

The study status axis: every transition is manual, gated and recorded in the audit trail.

What each status means and what you can do in it — see the Status reference.

Transitions have “gates” — conditions that must be met: Published design, Active site, No test subjects. Some transitions require a reason. The launch (Start UAT, Launch without UAT, Go-live) is performed in the Open enrollment zone of the Path to launch guide; details are in Publish a version and launch the study.

UAT is a test contour

In the UAT status every subject created is automatically flagged as a test subject and excluded from production exports. No test subjects may remain before go-live — they are removed explicitly, with a reason and an audit-trail entry.

The Overview screen

Overview is the entry point to the study; its content adapts to the status:

• in Draft — only the Path to launch guide: there are no subjects or queues yet;
• in UAT — the guide with the test-run checklist, and the overview below it (test data is already flowing);
• after launch — “needs your action”, key indicators and a breakdown by site.

The header shows the study code and title and its status. The Add subject button is shown to those who hold subject.create.

The Path to launch guide

A live list of the main path’s steps: it marks what is done and points to the next step. Each step links to the right screen.

1. Build the forms and visits — the Design section: the CRF builder and the SoA matrix; a ready design can be imported from a file following the template.
2. Publish the design — take the draft through review, approval and publication.
3. Add a site — at least one active site on the published version.
4. Test run (optional) — an end-to-end scenario on test subjects.
5. Open enrollment — open real subject enrollment.

Once the study is launched, the guide disappears: it is only needed during setup.

Study code ≠ site code

The study code (X7-042) is not a site code. Sites are added later, on the Sites screen, on top of the published design.