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Data Manager

Cleans data, owns queries (raise/close/reopen), runs exports.

Data Manager guide

What this role can do

  • Raise data queries
  • Close queries after review
  • Decide which fields require source verification
  • Sign off a version for release
  • Report protocol deviations
  • Set the safety report status of a serious event
  • Upload and version study documents
  • Run data exports

Boundaries (segregation of duties)

  • Cannot enter or correct clinical data
  • Cannot answer a query it raised (separation of duties)
  • Cannot perform source verification — only plan it
  • 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

Subjects

  • subject.readView subject data

Safety

  • clinical.event.readRead a subject’s events and the adverse event and SAE logs
  • clinical.event.reportSet the safety report status of a serious adverse event and its awareness time
  • clinical.event.reconcileRecord the reconciliation of a serious adverse event with the safety database
  • 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 queries
  • clinical.query.raiseOpen a new manual query
  • clinical.query.closeClose / resolve a query after answer reviewed
  • clinical.query.reopenReopen a closed query when answer is unsatisfactory

Monitoring

  • sdv.configureDefine the SDV / risk-based targeting plan (which fields require source verification)

Audit

  • audit.readAccess audit trail

Exports

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

Versioning

  • study.version.signoffSign off a version that passed UAT (author, QA or approver; three different people)
  • study.version.readView the study's versions: the version list, UAT cycles, sign-offs and the changes between versions
  • study.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

Documents

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

Continue reading

Work with queriesMonitor and verify dataExport dataClose and lock a studyCompare in the Permission Explorer →
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