CDM Integrity Systems — Clinical Data Management

CORPORATE AREA / TRUST CENTER

Audit trail & electronic signatures

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

No unsupported certifications. No trust by assertion.

01

Security & Privacy

Identity, access, encryption, data boundaries and threat-informed design.

02

Data Integrity

Provenance, timestamps, hashes, versioning and traceability throughout the lifecycle.

03

Audit Trail & Signatures

Append-only audit concepts and signature meaning subject to approved policy and validation.

04

Infrastructure & Continuity

Target architecture, backup, recovery, monitoring and resilience evidence as it becomes approved.