Creating a study

A study is the top-level container for all your work: the design (visits and forms), sites, subjects and data all live under it. It can be created by a user with the study.create permission at the tenant level — usually a tenant administrator. No modules are required for this: study creation and all the basic design work run out of the box.

StudySiteSubjectVisitFormField

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

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An administrator creates a study — code, title and an instant design draft.

Create a study

1. Open the Studies section and click New study (the button is visible only if you have the study.create permission).

2. Fill in the card:

   • Study code — a short working identifier (for example, X7-042). The code is used to find the study in lists and to refer to it in correspondence.
   • Protocol title — the full human-readable name.
   • Phase — an optional field: I, I/II, II, II/III, III, IV, NA or “Not specified”.

3. Click Create. The system takes you straight to the Study Design screen — this is where all the assembly begins.

A new study appears with the Draft status, and an empty design draft (version v1.0) is created automatically alongside it, ready to be filled in. You cannot enroll subjects or enter data yet — first you need to assemble and publish the design and launch the study.

Don't confuse the code with a site

The study code (X7-042) is not a site code. You will activate sites later, on a separate screen, on top of the published design (see Publishing & launch).

Study statuses

A study has its own status axis — it answers the question “what stage of life is the study as a whole in” and does not depend on either design versions or data locks. The order runs left to right; each transition is performed manually and recorded in the audit trail.

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

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

Status	What it means	What you can do
Draft	Design in progress — enrollment and data entry are closed	Assemble and publish the design
UAT	Test run on the published design	All clinical flows work, but subjects are marked as test
Active	The study is live	Enrollment and data entry are open; there are no more test subjects
Enrollment closed	No new subjects are enrolled	Visits, entry and cleaning for enrolled subjects continue
Closed	Collection is complete	New subjects and visits are not allowed; corrections (with a reason), queries, SDV and signatures still work — this is the cleaning phase before database lock
Archived	Terminal state	Read-only — no data operations are available

UAT is a test contour

While the study is in UAT, every subject created is automatically marked as a test subject and excluded from “production” exports, and a banner hangs above every screen: “Test contour — all data is test data”. Before the transition to Active (go-live) no test subjects may remain — either none were left, or an explicit cleanup recorded in the audit trail (see UAT and go-live).

Status transitions (for example, Start UAT, Go-live, Close enrollment, Close study) are performed on the lifecycle card of the Overview screen. Some transitions require a reason, and each has “gates” — conditions that must be met: a published design, at least one active site, no test subjects. A detailed walkthrough of the launch is in Publishing & launch; the full status machines are in the Status reference.

The Overview screen

Overview is the study dashboard and your entry point into it. Its composition adapts to the status so as not to show anything superfluous:

• The lifecycle card is always present: the current status, what it means for day-to-day work, and the available transitions. Blocking transition conditions are shown as a list with ✓ / ✗ marks even before you click — you immediately see what is missing.
• The Study launch checklist appears in the Draft and UAT statuses — this is the setup stage (see below).
• Metric tiles (subjects, forms, queries, SDV, signatures, locks) and the list of recent subjects appear once enrollment is under way. In Draft there are none — there is nothing to count yet.

In the screen header are the study code and title, the phase chip and the status chip. The Add subject button appears for anyone with the subject.create permission, but stays disabled until the design is published and the study is launched — with a hint about what is missing.

The Study launch checklist

This is a “live” list of the main-path steps — it guides you in order and marks what is already done (✓) and what to do now (→). Each step is a link to the relevant screen.

1. Assemble the design: visits and CRFs — opens the Study Design page, from which you reach the visual CRF Builder and the SoA matrix; a ready-made design can also be imported from JSON (see Publishing & launch).

2. Publish the design — take the draft through review and publication.

3. Activate a site — enable at least one site on the published design version.

4. UAT run — an end-to-end scenario on test subjects following the “UAT run” card’s checklist (can be skipped with a reason).

5. Go-live — start real subject enrollment.

Once all the steps are done, the study lives in the Active status and the checklist disappears — it is only needed during setup.

What’s next

CRF BuilderVisually assembling the draft's forms, fields and codelists.

Edit checksSystem and cross-field checks as part of the design.

Schedule of Activities (SoA)Define visits, windows and which forms belong to which visit.

Publishing & launchReview, publication, site activation, UAT and go-live.

Enrolling subjectsHow to add subjects after the study is launched.