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Per study9 permissions

Regulatory Manager

Manages regulatory document submissions and compliance tracking.

Regulatory Manager guide

What this role can do

  • Upload and version study documents
  • Run data exports
  • Read the audit trail

Boundaries (segregation of duties)

  • Cannot enter or correct clinical data
  • 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

Sites

  • site.readView site details

Audit

  • audit.readAccess audit trail

Documents

  • document.readView, download, and preview study documents
  • document.writeUpload documents, add versions, edit metadata
  • document.manageApprove and archive study documents

Exports

  • export.readView export history
  • export.runTrigger ad-hoc and signed exports