What this role is, and who it is for
You review the safety and the clinical plausibility of what the sites record. You are the one who records the medical review of a serious adverse event, you raise and close medical queries, and you read everything in 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: you review and query, and never change a site's data.
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 |
- Only what the role may open is listed.
What you can do
- Record the medical review of a serious adverse event: your assessment (agreed, disagreed or needs information), causality, expectedness and a comment, with a query to the site when something needs answering. A related and unexpected event is flagged as a suspected unexpected serious adverse reaction (SUSAR). The site does not see medical reviews (Review and reconcile a serious adverse event).
- Raise queries, close them once the site has answered and the answer is clinically satisfactory, and reopen them (Work with queries). You may close a query a site has answered; you may not answer one.
- Report adverse-event follow-up information and protocol deviations (Record an adverse event, Report a deviation).
- Read every participant, visit, form, adverse event and medication, the casebook, the reports and the audit trail across the study, and the study documents.
Every permission this role holds
15 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 | |
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.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.review | Record the medical review of a serious adverse event (agreed, disagreed, or needs information) | 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.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 or correct clinical data. You review it and query it ("You can read this record but not change it").
- Answer a query. The site answers; you close.
- Apply an electronic signature on a record. Signing a record is the principal investigator's: the permission left this role when record signing became investigator-only.
- Enroll or withdraw participants.
- Change the design or sign off a version. The release sign-off belongs to the Project Manager, the Data Manager and the Sponsor Manager.
- Perform source data verification, or export. You hold no export permission.
- Reconcile a serious event with the safety database. That is the Project Manager's and the Data Manager's.
How serious adverse events behave
When a serious adverse event is recorded, the system stamps the time the site became aware and starts the reporting clock (Record an adverse event). The system does not submit the report to a regulator: it is the evidence of what was captured, when awareness occurred, what was reviewed and what was done. The expedited submission happens in the sponsor's safety system, and the reconciliation records that the two agree.
What the system records
event.review_recorded, query.raised, query.closed, query.reopened, event.follow_up_recorded, deviation.reported. A later review replaces an earlier one in the log; every review stays on the event. See Audit events.
Seen in the simulation
Could: record a medical review of a serious adverse event (agreed, disagreed or needs information, causality, comment); raise a field query on an event; close a query. Could not: change the site's form; export.
- The medical officer's own act on a serious event.
Compliance Q&A
Yes. The medical review is recorded by the Medical Officer with the person, the time, the assessment, causality and expectedness; every review is kept, and the latest is shown. The site does not see it.
Limits: the system does not submit expedited reports to regulators or compute SUSAR reporting obligations beyond the flag (Not built yet).
Evidence: server events (event.review_recordedreview hidden from site staffonly clinical.event.review holders)simulation of 20 Oct 2026, step 6
Related
Review and reconcile a serious adverse event · Work with queries · Record an adverse event · Safety reporting