What this role is, and who it is for
You oversee how the sites are performing against the protocol, and you raise queries about what you find, without touching the data. The role is protocol-adherence oversight: it is not source data verification, which is the Clinical Research Associate's. 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), Sites, Participants, Casebook, Queries, AE Log, SAE Log, 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 | Results |
| Live only | Site Team, Reports: Lock readiness |
- Only what the role may open is listed.
What you can do
- Raise queries on any site's data (Work with queries).
- Read the study, its sites, participants, visits and forms, the adverse-event logs, the casebook, the audit trail and the e-signature register, and the study and site documents.
- Use the Site performance and Visit compliance reports (Use the reports and the dashboard).
Every permission this role holds
11 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.raise | Open a new manual query | organization, study | standard | separation of duties (query-raise-vs-answer) |
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.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
- Enter, correct, answer, close or reopen anything. Your only write action is raising a query.
- Perform source data verification. That is the Clinical Research Associate's role.
- Report a protocol deviation. You can raise a query about one; formal reporting sits with the monitor, the investigator, the coordinator, the Project Manager, the Data Manager and the Medical Officer.
- Activate or manage sites, or export.
How this differs from a Clinical Research Associate
| Site Monitor | Clinical Research Associate | |
|---|---|---|
| Verify data against source | No | Yes |
| Raise queries | Yes | Yes |
| Reopen queries | No | Yes |
| Report deviations | No | Yes |
| Read the e-signature register and audit trail | Yes | Yes |
| Focus | Site conduct and protocol adherence | Data accuracy at the datapoint level |
What the system records
query.raised, with the person and the time. See Audit events.
Seen in the simulation
Not tried.
Compliance Q&A
Yes. The Site Monitor can read and raise queries; every write to a site's data needs a permission held only at the site, which this role does not have.
Limits: the role was not exercised in the study simulations; the statement rests on the role catalog and the server's permission checks.
Evidence: role-catalog site_monitor (read permissions, clinical.query.raise only)permission checks in the server
Related
Work with queries · Open a site · Clinical Research Associate · Use the reports and the dashboard