What this role is, and who it is for
You are the monitor. You compare what the site entered with the site's source documents, record verified or discrepancy, and raise queries on what does not match. You are not confined to one site: you read every participant, visit and form of the study. You are given the role on the study's team by the Project Manager (Staff a study team). It is a study-team role, so you can read and query a site's data but never change it.
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), 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, SDV Monitoring, 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 |
SDV Monitoring is your queue: Verified, Needs attention, Pending first verification, Need re-verify, Discrepancies.
What you can do
- Perform source data verification on the datapoints the plan targets, and on adverse event and medication values: verify a value, log a discrepancy, verify again after a change (Monitor and verify data).
- Raise queries on any value at any site of the study, and reopen a closed query whose answer does not hold up (Work with queries).
- Report protocol deviations (Report a deviation).
- Take part in UAT: read and raise issues against the design under test (Test a version in UAT).
- Read participants, visits, forms, sites, the casebook, the adverse-event logs, the reports, the e-signature register and the audit trail across the study, and the study and site documents.
Every permission this role holds
16 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 | |
form.read | Open forms and view answers | organization, study, site | standard | |
sdv.perform | Verify captured data against source documents (perform SDV) | 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.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 | |
deviation.report | Report and update protocol deviation status | 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.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
- Enter or correct data. Monitoring is observation: if a value is wrong, you raise a query and the site corrects it ("You cannot edit the field value").
- Answer a query. The site answers.
- Close a query. The Data Manager, the Clinical Data Coordinator or the Medical Officer closes it, never the role that raised or answered it.
- Verify a value you entered, or one your save derived. The rule is in the server and the database.
- Decide what is verified. The SDV plan is set by the Data Manager or the Project Manager; you work the plan.
- Sign records, or export. You hold no export permission, and the Exports page shows you no controls.
How verification stays honest
A verification records the exact value you saw, as a hash. If anyone later changes that value, your verification becomes Stale and the datapoint returns to your queue; you are never credited with having verified something that has since changed. A discrepancy stays until you verify the datapoint again, whatever the value becomes.
What the system records
sdv.verified, sdv.discrepancy, query.raised, query.reopened, deviation.reported, each with the person and the time. See Audit events.
Seen in the simulation
Could: raise a field query; verify a datapoint against source, log a discrepancy and verify again after a changed value; read SDV monitoring and the reports pages. Could not: open the Exports page (no controls); edit data; close a query.
Compliance Q&A
Yes. A monitor verifies a value that someone else entered; the verification stores a hash of that value and goes stale if the value changes.
Limits: the plan decides what is verified; risk-based monitoring and central monitoring across participants are not built (Not built yet).
Evidence: server/src/modules/study/sdv (append-only ledger with value hashentered-by cannot verify, in application and database)simulation of 20 Oct 2026
Related
Monitor and verify data · Work with queries · Use the casebook · Who can and cannot