Clinical Development Hub
Local Demo
Home/dct/econsent

eConsent

eConsent lifecycle with version controls and audit traceability. This workspace exists to enforce consistent clinical execution with accountable ownership, governed evidence, and inspection-ready traceability across the study lifecycle. It supports business and regulatory requirements by connecting operations, quality, submissions, and financial controls in a single system where handoffs are explicit and auditable. Users can proceed by filtering scope, reviewing linked artifacts and actions, and routing escalations with defined approval gates and signature meaning.

eConsent Lifecycle

Consent Versions
40,000
Reconsent Needed
15,000
Audit Completeness
2,800

Consent Version Actions

ItemDetails
TRN-900expiry in 14d | DoA role check pass
TRN-901current | DoA role check review
TRN-902current | DoA role check pass
TRN-903current | DoA role check review
TRN-904expiry in 14d | DoA role check pass
TRN-905current | DoA role check review
TRN-906current | DoA role check pass
TRN-907current | DoA role check review
TRN-908expiry in 14d | DoA role check pass
TRN-909current | DoA role check review

Add Consent Version Actions Entry

Access & Governance Controls
RBAC+ABACStudy Firewall ActiveRestricted Zone

Operational Controls

Study firewalling chips highlight boundary, country constraints, and vendor partition rules.

Actions requiring GxP control include a human review checkpoint and e-signature meaning capture.

Every state change writes immutable audit evidence with actor, timestamp, and object reference.

Next Actions

Filter to portfolio/program/study context.

Open linked tasks, risks, and document evidence.

Escalate blocked items through governed workflow.