What this role is, and who it is for
You watch the study without being able to change it, and you are the approver leg of the three-way release sign-off. You work for the sponsor, not for the organization that runs the study, so you are an external study member: the Project Manager invites you on the study's team with the Add sponsor staff tab, and you are never a member of the organization (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, Exports, Audit Trail |
| Build | Build (dashboard), Corrections, Amendment, Saves, Forms, Visit Schedule, Form builder |
| UAT and Live | Dashboard, Forms (the design this workspace runs, read-only), Visit Schedule (read-only), Sites, Participants, Casebook, Queries, AE Log, SAE Log, Exports, Reports: Enrollment, Reports: Site performance, Reports: Query aging, Reports: Visit compliance, Reports: Protocol deviations, E-Signatures, Audit Trail, Site: Queries, Site: Documents, Site: Staff, Participant: Queries, Participant: AEs and medications |
| UAT only | Issues, Results |
| Live only | Site Team, Reports: Lock readiness |
- Only what the role may open is listed.
What you can do
- Read the study, its sites, participants, visits, forms and queries, the adverse-event logs, the casebook, the reports and the dashboard, the e-signature register and the audit trail (Use the reports and the dashboard).
- See the versions: the version history, what changed and who signed it, and the UAT results (Review and release a study).
- Apply the approver sign-off on a version, with a fresh code. The sponsor's approval is the last of the three (Sign off a version and go live).
- See and download exports that others produced, and read the study documents (Export data).
Every permission this role holds
13 permissions (template version 5).
| Permission | What it allows | Held at | Risk | Constraint |
|---|---|---|---|---|
audit.read | Access audit trail | organization, study, site | standard | |
document.read | View, download, and preview study documents | organization, study, site | standard | |
export.read | View export history | organization, study | standard | |
form.read | Open forms and view answers | organization, study, site | standard | |
clinical.query.read | View queries | organization, study, site | standard | |
clinical.event.read | Read a subject’s events and the adverse event and SAE logs | organization, study, site | standard | |
site.read | View site details | organization, study, site | standard | |
study.read | View study details and dashboards | organization, study, site | standard | |
subject.read | View subject data | organization, study, site | standard | |
study.version.signoff | Sign off a version that passed UAT (author, QA or approver; three different people) | organization, study | critical | needs an e-signature |
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 |
What you cannot do, and why
- Write anything except your sign-off. No data entry, no queries raised, answered or closed, no site or team changes, no design changes.
- Start an export. You can see the Exports page and the list; the Data Manager, the Project Manager, the Regulatory Manager or the Organization Admin produces the files.
- Change the study's state. The state chip is a plain label for you.
- Sign as author or QA, or sign twice. Three different people sign a version, each in the capacity their role gives them.
- Perform or plan source data verification.
The sign-off you own
A version needs three sign-offs: author (the Project Manager), QA (the Data Manager) and approver (you). The system works out which you are from your role; you cannot choose. The signature is a real electronic signature: it asks for a fresh code sent to your address and your typed name, and it is bound to the exact design the passed UAT cycle tested. If the design changes afterwards, your sign-off no longer counts and the release is blocked until it is applied again.
What the system records
study.version.signoff_recorded, signature.applied, auth.stepup.verified. See Audit events.
Seen in the simulation
Could: sign as approver on a version with a step-up code; see the Exports page (list) and the e-signature register. Could not: start an export; change the study state.
Compliance Q&A
Yes. The approver's signature is the Sponsor Manager's alone and is the last of three signatures by different people, each with a fresh code and bound to the tested design.
Evidence: server versions sign-off (approver is the Sponsor Manager's capacitythree different peoplestep-up codebound to the tested snapshot)simulation of 20 Oct 2026
Related
Sign off a version and go live · Review and release a study · Use the reports and the dashboard · Staff a study team