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Excursions

Temperature or handling excursion queue with CAPA linkage. 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.

Excursion Management

Excursions
388
Critical
44
Closed
344
Excursions
Critical
Closed

Excursion CAPA Queue

KRI-00001 | Late TMF filing>3 cases/week | Up | Central Monitor
KRI-00002 | SAE follow-up lag>15 open/site | Stable | Central Monitor
KRI-00003 | Missing endpoint>10 days | Down | Central Monitor
KRI-00004 | Late TMF filing>5% | Up | CTM
KRI-00005 | SAE follow-up lag>5% | Up | Safety Lead
KRI-00006 | Late TMF filing>15 open/site | Stable | Central Monitor
KRI-00007 | Late TMF filing>10 days | Up | Safety Lead
KRI-00008 | Late TMF filing>3 cases/week | Stable | CTM
KRI-00009 | Query aging>15 open/site | Up | Safety Lead
KRI-00010 | Missing endpoint>10 days | Down | Safety Lead
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.