What this role is, and who it is for
You support data cleaning by reviewing the site's answers and closing the queries that are really resolved. The role is deliberately narrow: closing a query is a quality act that has to be done by someone who took no part in raising or answering it, and this role lets closure be resourced without handing out the wider data-management permissions. You are given the role on the study's team by the 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, Audit Trail |
| Build | Build (dashboard), Amendment, Saves, Forms, Visit Schedule, Form builder |
| UAT and Live | Dashboard, Forms (the design this workspace runs, read-only), Visit Schedule (read-only), Participants, Casebook, Queries, AE Log, SAE Log, Reports: Enrollment, Reports: Query aging, Reports: Protocol deviations, E-Signatures, Audit Trail, Site: Queries, Site: Documents, Participant: Queries, Participant: AEs and medications |
| UAT only | Results |
| Live only | Reports: Lock readiness |
What you can do
- Close queries the site has answered (Work with queries).
- Read every participant, visit, form, adverse event and query in the study, the casebook and the audit trail, so that you can see exactly what changed in response to a query before you close it.
- Read study documents.
Every permission this role holds
10 permissions (template version 4).
| 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 | |
form.read | Open forms and view answers | organization, study, site | standard | |
clinical.query.read | View queries | organization, study, site | standard | |
clinical.query.close | Close / resolve a query after answer reviewed | organization, study | standard | |
clinical.event.read | Read a subject’s events and the adverse event and SAE logs | 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.read | View the study's versions: the version list, UAT cycles, sign-offs and the changes between versions | organization, study | standard | |
visit.read | View visit schedule and data | organization, study, site | standard |
What you cannot do, and why
- Raise a query. The Data Manager, a monitor, the Medical Officer, a site monitor or the Project Manager raises them.
- Answer a query. The site answers.
- Reopen a closed query. If you closed one in error, a Data Manager, a monitor or the Medical Officer reopens it.
- Enter or correct data, run exports, or see the Sites screens: your access is to the data, not to the site register.
- Close a query you answered or raised. No role does; you do neither.
What the system records
query.closed, with the person and the time. See Audit events.
Seen in the simulation
Could: close an answered query (tested). Everything else: not tried.
Compliance Q&A
Yes. A query is closed by a person who neither raised nor answered it, and the role that answers can never close. The closure is attributed and timed in the audit trail.
Evidence: server queries (separation of duties in the application and a database trigger)simulation of 20 Oct 2026 (closing tested)