What this role is, and who it is for
You build the forms, the visit schedule and the mapping of a study, and you never see a participant's data: the role holds no permission over participants, queries or events. The design you draw is frozen when the version goes to UAT, tested by others, signed off by three other people and then released; changing it afterwards is an amendment. You are given the role on a study's team by its Project Manager (Staff a study team).
Where you work
| Where | Screens |
|---|---|
| Organization | Studies, Form Library, Settings, Library form builder |
| The study (outside UAT and Live) | Overview, Study Versions, Documents |
| Build | Build (dashboard), Corrections, Amendment, Saves, Forms, Visit Schedule, Visit and Form Mapping, AI Workstation, Form builder |
| UAT and Live | Forms (the design this workspace runs, read-only), Visit Schedule (read-only), Mapping (read-only), Site: Documents |
| UAT only | Issues, Results |
| Live only | Reports: Lock readiness |
In practice your menu is short: Overview, Study Versions, Documents, and the Build workbench of the version being built. Once the version is Live the Build entry is gone from your menu, until an amendment is started.
- The designer's entry to the design of the version.
What you can do
- Design forms in the builder: sections, tables, 20 field types, conditional visibility, formulas, validation and edit checks (The form builder, Design forms).
- Generate a first draft with AI from a plain-language prompt, then edit it like any other form. This needs the organization to be licensed for it (AI form generation and the AI workstation).
- Make forms active and take them back to draft while the study has never released a version (Versions, reopening and what publishing locks).
- Design the visit schedule, and map forms to visits (Plan visits, Binding a form to visits).
- Promote forms to the form library so other studies can reuse them (Use the form library).
- Preview and test a form as a site would see it (Preview and testing a form).
- Read the UAT issues found in your design, and mark each correction resolved as you make it when UAT sends a version back (Correct a design after UAT); read the study's documents.
Every permission this role holds
12 permissions (template version 3).
| Permission | What it allows | Held at | Risk | Constraint |
|---|---|---|---|---|
ai.generate | Generate or edit forms with AI | organization, study | standard | |
document.read | View, download, and preview study documents | organization, study, site | standard | |
form.read | Open forms and view answers | organization, study, site | standard | |
form.design | Edit form templates in builder | organization, study | standard | |
form.publish | Publish form versions to live | organization, study | standard | |
form.freeze | Marks a role as data-locking authority (separation of duties: cannot also enter data) | organization, study | standard | separation of duties (enter-vs-lock) |
library.write | Create / edit shared library forms | organization, study | elevated | |
study.read | View study details and dashboards | organization, study, site | standard | |
study.version.read | View the study's versions: the version list, UAT cycles, sign-offs and the changes between versions | organization, study | standard | |
study.uat_issue.read | View the issues and results of a UAT cycle (what testers found, and what became of it) | organization, study, site | standard | |
visit.read | View visit schedule and data | organization, study, site | standard | |
workflow.design | Build and edit workflows | organization, study | elevated |
What you cannot do, and why
- See clinical data. You hold no permission over participants, sites, queries or events. Forms yes; the answers people put in them, no. That is the point of the role.
- Sign off a version. You build it; the Project Manager, the Data Manager and the Sponsor Manager sign it, each in their own capacity. There is no Sign off control for you.
- Move the study through its states, or take a version to UAT or Live. Those are the Project Manager's and the Organization Admin's.
- Change the design of a version after it is submitted to UAT. The design is frozen for the cycle, for the sign-off and until it is released. There are two ways back: a UAT cycle that fails returns the version to Build with its findings, and a released study is changed by an amendment, a new version built beside the Live one.
- Edit an Active form in place once the study has released a version. You create a new version of the form.
What the system records
form.created, form.draft_saved, form.version_created, form.transitioned, study.version.revision_saved (each save of the design in Build), and library_form.changed when a form in the library is created or changed. See Audit events.
Seen in the simulation
Could: create and edit forms, visits, the visit–form matrix and rules in Build; use the AI form generator (once); preview forms; promote forms to the library; build a 12-lead ECG form for an amendment. Could not: sign off a version (no control); open Build after the version went Live (the entry is gone from the menu); see participant data (the menu shows only Overview, Study Versions and Documents).
Compliance Q&A
Yes. The eCRF Designer holds no permission to read participants, queries or events and cannot sign off a version.
Evidence: role-catalog ecrf_designer (no subject.read, no clinical.* permissions)simulation of 20 Oct 2026 (menu: Overview, Study Versions, Documents)
Yes. The design is frozen when the version is submitted to UAT, and the sign-offs are bound to the snapshot the cycle tested. A change after release is an amendment that is built, tested and signed like the first version.
Evidence: server versions (design frozen at submissionsnapshot hashchanges only by amendment)form lifecycle
Related
The form builder · Design forms · Plan visits · Correct a design after UAT · Review and release a study