Build a study

What this is, and who it is for#

A study's design (its forms, visit schedule, the mapping of forms to visits, and rules) is built inside a version that is in Build. The Build workbench is the home of that work: it tells you which design you are in, the one thing to do next, where each of the four steps stands, and what is still outstanding before the design can go for review. The first version is 1.0; later versions are amendments of a Live version (Amend a live study).

Held by: Organization Admin, Project Manager, eCRF Designer (form.design or study.write).

Nobody builds on the Live study. The design is editable in exactly one state: Build.

Where to find it#

Study → Build. The Build menu lists: Build (the workbench), UAT corrections (only after a cycle sent the design back), Amendment (only in an amendment), Save history, Forms, Visit Schedule, Visit ⇄ Form Mapping and AI Workstation (experimental). The form builder opens in its own full-screen layout (The form builder).

What you can do#

Read the workbench#

• The version bar. The version number and a state chip (IN BUILD, IN UAT · CYCLE 2, AWAITING SIGN-OFF, APPROVED, LIVE, SUPERSEDED, WITHDRAWN), kind chips (AMENDMENT, MINOR CHANGE, RE-CONSENT REQUIRED), a line saying where it has been (Initial build, Back from UAT cycle 1, Live since 4 Oct), the revision and who saved last (Revision 14, saved 09:42 by you), and one button for the next thing to do: Create the first form for an empty design, Continue with form VS (the place of your last save), Continue with the visit schedule or the mapping, Open the forms, or Open the corrections when a UAT round sent findings back. A frozen design shows This design is frozen and no button.
• The four steps, as cards with a count and a hint: 1 Forms (the number of forms, fields, how many are in draft), 2 Visit schedule (active visits; N visits hold no form is flagged), 3 Visit–form mapping (bindings; N forms are not held by a visit is flagged), 4 Rules (active rules; edit checks sit on the fields of a form). An empty design marks START HERE on the first. Each card opens its screen.
• To do before review. Only the checks that fail, each with a Fix in … link. A design is judged by the same checks the server makes when it is submitted (Preview and testing): the design has something in it; the protocol is on file; every form is held by a visit; every visit holds a form; codes are unique; bindings and rules point at things the version has; event forms say what they are; each check says what it does when it fails; and, in an amendment, the changes fit the data already captured. A missing protocol is flagged as a warning for a Project Manager to upload under Documents (Open Documents or View Documents). Checks that pass are folded behind N other checks pass. When nothing fails the panel says NOTHING TO FIX.
• For a design sent back from UAT: a callout Back from UAT cycle 1: 3 corrections are still open, with N of M resolved (Correct a design after UAT).
• For an amendment: This amendment with Why it was started, SITES MUST RE-CONSENT SUBJECTS where that applies, and a comparison Against the Live version, made when the version is submitted to UAT.

You can export the draft design from the workbench as a data dictionary or ODM-XML for review (Importing and exporting a design).

1

Enlarge

1. Opens the Build workbench of version 1.0.

Enlarge

Build, in this order#

1. Create the study's documents. Upload the protocol under Documents. A version cannot be submitted to UAT with no protocol on file (Manage documents).
2. Fill in Study Settings (title, phase, dates, endpoints, the serious-event reporting windows, the signatures a visit and a casebook ask for), which are kept in the version (Settings).
3. Forms. Create each form, import it from the library, or generate a draft with AI; then draw it (Design forms).
4. Visit schedule. Define the visits (Plan visits).
5. Visit ⇄ Form Mapping. Bind each form to the visits that collect it (Binding a form to visits).
6. Staff the team you need for testing (Staff a study team); roles other than the build team can be added at any time, including in Setup.
7. Work down To do before review until it says NOTHING TO FIX, then ask your Project Manager to submit the version to UAT (Review and release a study).

You can do them in any order; the dependencies are that a binding needs a form and a visit.

Every option#

Save history#

Save history lists every save to the design of this version, newest first: the revision, when, who, and which forms, visits, mappings and rules it changed (their codes, never their content). Filter by round (a round is the time between submissions to UAT), search a code, and page through. It is the record of how the design came to be what it is.

Enlarge

What each state allows#

What the system records#

Every save of the design is a revision (study.version.revision_saved and the per-entity events such as form.draft_saved, mapping.bound, study_visit.changed). The design that goes to UAT is a snapshot with a content hash. See Audit events.

What you cannot do, and why#

• Edit a frozen design. What was tested and signed is what runs.
• Submit to UAT from the workbench. The Project Manager does that from Versions (Review and release a study); the workbench only shows what is outstanding.
• Submit with no protocol on file, an empty design, a form no visit holds, or a visit with no form. The checks refuse with the whole list at once.
• Build the same study twice at once. A study has one version in flight at a time.

Compliance Q&A#

Related#

Design forms · Plan visits · Review and release a study · The form builder · Settings · Project Manager · eCRF Designer