What this is, and who it is for
A study's design reaches participants only through a fixed path, and every step has a different person and leaves a record. This page is the map of the path; the two pages after it do the detail.
| Step | Who | Page |
|---|---|---|
| Build the design | eCRF Designer, Project Manager | Build a study |
| Submit to UAT | Project Manager or Organization Admin (study.version.submit_uat) | below |
| Test it in a UAT cycle; pass or fail it | Testers enter and raise issues; the Project Manager or Organization Admin closes the cycle (study.uat.close_cycle) | Test a version in UAT |
| Three sign-offs: Author, QA, Approver | Project Manager, Data Manager, Sponsor Manager (study.version.signoff, three different people) | Sign off a version and go live |
| Go live | Project Manager or Organization Admin (study.version.go_live) | Sign off a version and go live |
| Withdraw a version set aside | Project Manager or Organization Admin (study.version.withdraw) | below |
Held by: Organization Admin, Project Manager (study.version.submit_uat).
Held by: Organization Admin, Project Manager (study.uat.close_cycle).
Held by: Organization Admin, Project Manager (study.version.go_live).
Held by: Organization Admin, Project Manager (study.version.withdraw).
A study has one version in flight at a time. The design is editable only in Build; from the moment it is submitted it is frozen, so what was tested and signed is what goes Live.
Where to find it
Study → Versions (at the study level; the page is titled Study versions). The list shows each version with its state and actions; a version's own page (Version details) shows its facts, its UAT cycles, its sign-offs, its lifecycle from the audit trail, its draft history and, for an amendment, the comparison with the Live version. The stages table lists Build, then one row for each UAT cycle, then Live, with Status, Last updated, Updated by, Result and an Enter action where the stage can be entered (Find your way).
What you can do
Submit to UAT
- On Versions, choose Submit to UAT for the version in Build. The dialog (Submit 1.0 to UAT) says: Freezes the design for validation: its draft forms are published and the whole design is compiled into the snapshot that UAT tests and the sign-offs bind to. Any later change is a new submit, a new snapshot and a new cycle. The UAT workspace opens a cycle of test data.
- If the design has problems the submit refuses with the whole list at once (the same list as To do before review on the Build home): an empty design; duplicate codes; a binding or rule to something the version does not have; a form no visit holds; a visit with no form; no protocol on file; event forms that do not say what they are; check severities that cannot be read; and, in an amendment, a breaking change to a field that holds Live data, with each change and what to do instead.
- When it passes, in one transaction: the draft forms are made active, the design is compiled into a snapshot with a content hash, a UAT cycle (numbered 1, 2…) is opened on it, and the version moves to UAT.
- Freezes the design and opens a UAT cycle.
Withdraw a version
Withdraw sets a version aside for good before it goes Live: It is kept, read-only, with its history; an open UAT cycle closes as failed so none is left open on a dead version. Its sign-offs are withdrawn. The Live version is unaffected. A reason is required.
Read the version
The Version details page shows: created, build and approved dates, the kind (initial, amendment, minor), whether participants must re-consent, the state of moving participants to a new version, the UAT cycles (opened, closed, participants, records, queries, signatures, result), the sign-offs, the lifecycle (who moved it, when and why) and the draft history (every save).
Every option
What a UAT submission freezes
The forms (published), the visits, the bindings, the rules, the study settings and the check severities are compiled into the snapshot. Its SHA-256 is what the sign-offs bind to (Sign off a version and go live). Any change after the submission means a new submission, a new snapshot, a new cycle and new sign-offs.
The kinds of version
| Kind | What it is |
|---|---|
| Initial | Version 1.0, made with the study |
| Amendment | A change to a Live design, with a reason, and a choice whether participants must consent again (Amend a live study) |
| Minor change | A configuration-only change |
What the system records
study.version.submitted_to_uat, uat.cycle.opened, uat.cycle.passed or uat.cycle.failed, study.version.signoff_recorded or study.version.signoff_rejected, study.version.approved, study.version.went_live, study.version.superseded, study.version.withdrawn, study.version.returned_to_build, each with the person, the time and (where one is asked) the reason. See Audit events.
What you cannot do, and why
- Release without testing or signatures. Go live needs a passed cycle and three current sign-offs by three people on the snapshot that was tested.
- Edit the design in UAT. Fail the cycle or reject a sign-off to return it to Build.
- Submit a design with the problems above. The list is the same one the Build home shows.
- Run two versions through at once.
- Reuse a failed cycle. A failed cycle is kept as evidence; resubmitting opens the next cycle on a new snapshot.
Compliance Q&A
Yes. A design cannot go Live without a passed UAT cycle on a hash-stamped snapshot and three signatures by three different people bound to that snapshot, and every move is recorded.
Limits: the system enforces that the path was followed; the adequacy of the testing is the study team's.
Evidence: server/src/modules/study/versions (submit-to-uat.ts, close-cycle.ts, signoff.ts, go-live.ts)ADR 0012
Related
Test a version in UAT · Sign off a version and go live · Amend a live study · Correct a design after UAT · Statuses · Environments and versioning