What this role is, and who it is for
You own data quality. You raise and close queries, decide what the monitors verify, run the exports, reconcile serious adverse events with the safety database, and you are the QA leg of the release sign-off. You review the design before it goes live, and the data after. 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, 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), Participants, Casebook, Queries, AE Log, SAE Log, SDV Plan, SDV Monitoring, Exports, Reports: Enrollment, Reports: Query aging, Reports: Protocol deviations, E-Signatures, Audit Trail, Site: Queries, Site: Documents, Participant: Queries, Participant: AEs and medications |
| UAT only | Issues, Results |
| Live only | Reports: Lock readiness |
What you can do
- Raise queries, close them once the site has answered and the answer holds up, reopen them when it does not, and escalate (Work with queries).
- Define the SDV plan: which fields, forms and visits a monitor must verify (Monitor and verify data).
- Run and download exports in Excel, CSV (zip) or CDISC ODM-XML (Export data).
- Sign as QA on a version, with a fresh code (Sign off a version and go live); read and raise issues against the design in UAT (Test a version in UAT).
- Report adverse events and deviations, and reconcile a serious adverse event with the safety database (Review and reconcile a serious adverse event).
- Upload and version study documents (for example the Data Management Plan) (Manage documents).
- Read participants, visits, forms, the casebook, the reports and the lock-readiness report, the e-signature register and the audit trail (Use the reports and the dashboard).
Every permission this role holds
22 permissions (template version 6).
| 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 | |
document.write | Upload documents, add versions, edit metadata | organization, study | standard | |
export.read | View export history | organization, study | standard | |
export.run | Trigger ad-hoc and signed exports | organization, study | critical | |
form.read | Open forms and view answers | organization, study, site | standard | |
sdv.configure | Define the SDV / risk-based targeting plan (which fields require source verification) | organization, study | standard | |
clinical.query.read | View queries | organization, study, site | standard | |
clinical.query.raise | Open a new manual query | organization, study | standard | separation of duties (query-raise-vs-answer) |
clinical.query.close | Close / resolve a query after answer reviewed | organization, study | standard | |
clinical.query.reopen | Reopen a closed query when answer is unsatisfactory | organization, study | standard | |
clinical.event.read | Read a subject’s events and the adverse event and SAE logs | organization, study, site | standard | |
clinical.event.report | Set the safety report status of a serious adverse event and its awareness time | organization, study, site | standard | |
clinical.event.reconcile | Record the reconciliation of a serious adverse event with the safety database | organization, study | standard | |
deviation.report | Report and update protocol deviation status | 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 | |
study.uat_issue.write | Raise, edit, resolve, accept and reopen the issues of the open UAT cycle | organization, study, site | standard | |
visit.read | View visit schedule and data | organization, study, site | standard |
What you cannot do, and why
- Answer a query. The site answers, and the system enforces it: the person closest to the source answers, an independent person closes.
- Enter or correct clinical data. You can read every value; you cannot change one. If data is wrong, you raise a query and the site corrects it.
- Perform source data verification. You decide what is verified; the monitor verifies.
- Change the study's state, or request or confirm a lock. The state chip is a plain label for you; the state is the Project Manager's and the Organization Admin's to change.
- Sign as author or approver, or sign a record as investigator.
- Be site staff. A person on the organization team is never site staff.
Why raise and close, but not answer
It looks asymmetric and is intentional. You flag a discrepancy, the site resolves it, you confirm the resolution. What must never happen is one person both flagging and answering; the split is enforced in the standard roles and in any custom role.
What the system records
query.raised, query.closed, query.reopened, query.escalated, sdv.plan_updated, export.requested, export.completed, export.downloaded, study.version.signoff_recorded, event.reconciliation_recorded, document.*. See Audit events.
Seen in the simulation
Could: sign as QA on a version; close, reopen and escalate answered queries; start whole-study exports (Excel, CSV zip, ODM-XML); reconcile a serious adverse event with the safety database; read reports and lock readiness. Could not: answer a query (no response box); change the study state (plain chip); be provisioned as site staff.
Compliance Q&A
Yes. The Data Manager holds no permission to write data or answer a query. A query is closed by someone who did not answer it, and the history of every correction is in the audit trail.
Evidence: server queries (separation of duties in the application and a database trigger)simulation of 20 Oct 2026 (Data Manager closesno response box)
Related
Work with queries · Monitor and verify data · Export data · Close and lock a study · Who can and cannot