CDM Integrity Systems — Clinical Data Management

CORPORATE AREA / CDM SENTINEL

Evidence & audit readiness

This page is part of CDM's corporate information architecture and develops the topic in its own context, independently from the homepage.

01

PURPOSE

Explain how this capability fits within a connected and traceable clinical-research model.

02

OPERATING MODEL

Connect information, actions, owners and evidence without erasing human accountability or source context.

03

EVIDENCE & SCOPE

Specific functions and external claims will be published only when supported by verifiable documentation and approval.

CONTENT ARCHITECTURE

Integrity Systems operates the research. Sentinel proves its integrity.

01

Governance

Versioned frameworks, requirements, controls, ownership and review cycles.

02

Risk & Quality

Risks, findings, CAPA, assessments and accountable follow-up.

03

Evidence

Automatic and documentary evidence with provenance, timestamps and integrity attributes.

04

Audit Readiness

Traceable packages, manifests and status explanations designed to support review.