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KRI / QTI

Thresholds, owners, escalation rules, and evidence-linked alerts. 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.

KRI / QTI Definitions

Late TMF filing (>3 cases/week) | Owner: Central MonitorUp

SAE follow-up lag (>15 open/site) | Owner: Central MonitorStable

Missing endpoint (>10 days) | Owner: Central MonitorDown

Late TMF filing (>5%) | Owner: CTMUp

SAE follow-up lag (>5%) | Owner: Safety LeadUp

Late TMF filing (>15 open/site) | Owner: Central MonitorStable

Late TMF filing (>10 days) | Owner: Safety LeadUp

Late TMF filing (>3 cases/week) | Owner: CTMStable

Query aging (>15 open/site) | Owner: Safety LeadUp

Missing endpoint (>10 days) | Owner: Safety LeadDown

Late TMF filing (>3 cases/week) | Owner: Central MonitorDown

Missing endpoint (>3 cases/week) | Owner: Data LeadStable

SAE follow-up lag (>10 days) | Owner: Data LeadStable

Missing endpoint (>3 cases/week) | Owner: Safety LeadStable

Missing endpoint (>15 open/site) | Owner: CTMStable

SAE follow-up lag (>15 open/site) | Owner: Data LeadUp

Query aging (>3 cases/week) | Owner: Safety LeadStable

Missing endpoint (>15 open/site) | Owner: Data LeadUp

Late TMF filing (>10 days) | Owner: CTMUp

Query aging (>15 open/site) | Owner: CTMDown

Alerts to Investigations to CAPA to Evidence

Access & Governance Controls

RBAC+ABACStudy Firewall Active

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.