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CRA
Clinical Research Associate guidePer study16 permissions
Clinical Research Associate
Monitors site data quality (SDV), views data, raises queries (cannot edit or answer).
What this role can do
- Raise data queries
- Verify data against source documents
- Report protocol deviations
- 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 versionsstudy.uat_issue.readView the issues and results of a UAT cycle (what testers found, and what became of it)study.uat_issue.writeRaise, edit, resolve, accept and reopen the issues of the open UAT cycle
Sites
site.readView site details
Subjects
subject.readView subject data
Safety
clinical.event.readRead a subject’s events and the adverse event and SAE logsdeviation.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.reopenReopen a closed query when answer is unsatisfactory
Monitoring
sdv.performVerify captured data against source documents (perform SDV)
Audit
audit.readAccess audit trail
Documents
document.readView, download, and preview study documents
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