II.
Workflow overview
Reference · liveworkflow:clinical-data-pipeline-review
Clinical Data Pipeline Review overview
Reviews clinical data pipelines for CDISC/SDTM compliance -- validating data transformations from EDC systems, checking derivation logic against analysis datasets, ensuring audit trail integrity for 21 CFR Part 11 compliance, verifying de-identification procedures for PHI, and confirming data lock readiness for statistical analysis. Excludes statistical analysis itself.
Attributes
displayName
Clinical Data Pipeline Review
workflowKind
governance
triggerType
event-driven
typicalCadence
per-study
complexity
single-team
description
Reviews clinical data pipelines for CDISC/SDTM compliance --
validating data transformations from EDC systems, checking derivation
logic against analysis datasets, ensuring audit trail integrity for
21 CFR Part 11 compliance, verifying de-identification procedures for
PHI, and confirming data lock readiness for statistical analysis.
Excludes statistical analysis itself.
Outgoing edges
applies_to_domain2
- domain:biomedical-engineering·DomainBiomedical Engineering
- domain:scientific-computing·DomainScientific Computing
involves_role3
- role:data-scientist·RoleData Scientist
- role:staff-engineer·RoleStaff Engineer
- role:security-reviewer·RoleSecurity Reviewer
performed_by_org_unit2
- org-unit:data-team·OrgUnitData Team
- org-unit:research-engineering·OrgUnitResearch Engineering
requires_skill_area2
- skill-area:python-data-pipelines·SkillAreaPython Data Pipelines
- skill-area:observability-pipeline·SkillAreaObservability Pipeline
triggers_responsibility2
- responsibility:data-quality-monitoring·ResponsibilityData quality monitoring
- responsibility:security-review·ResponsibilitySecurity review
Incoming edges
None.