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Medical Officer guidePer study15 permissions
Medical Officer
Reviews safety/AE and manages medical queries.
What this role can do
- Raise data queries
- Close queries after review
- Report protocol deviations
- Set the safety report status of a serious event
- Read the audit trail
Boundaries (segregation of duties)
- Cannot enter or correct clinical data
- Cannot answer a query it raised (separation of duties)
- Cannot sign anything
- Cannot change the study or its form design
Exact permissions
The real permissions this role carries, taken from the platform’s own catalogue. Holding a permission is necessary but not sufficient — access is further narrowed by study membership, site, and whether the study’s data is test or live.
Studies
study.readView study details and dashboards
Versioning
study.version.readView the study's versions: the version list, UAT cycles, sign-offs and the changes between versions
Subjects
subject.readView subject data
Safety
clinical.event.readRead a subject’s events and the adverse event and SAE logsclinical.event.reportSet the safety report status of a serious adverse event and its awareness timeclinical.event.reviewRecord the medical review of a serious adverse event (agreed, disagreed, or needs information)deviation.reportReport and update protocol deviation status
Visits
visit.readView visit schedule and data
Forms
form.readOpen forms and view answers
Queries
clinical.query.readView queriesclinical.query.raiseOpen a new manual queryclinical.query.closeClose / resolve a query after answer reviewedclinical.query.reopenReopen a closed query when answer is unsatisfactory
Audit
audit.readAccess audit trail
Documents
document.readView, download, and preview study documents