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RTSM / IRT Oversight

Randomization and kit allocation health monitoring. 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.

RTSM/IRT Health

Randomization Events
25,000
Kit Mismatch
18,770
Site Shortage Risk
6,298
Randomization Events
Kit Mismatch
Site Shortage Risk

Allocation Exceptions

REC-000001 | eCOA/EDCResolved | High | STUDY-0001
REC-000002 | EDC/eCOAEscalated | Medium | STUDY-0002
REC-000003 | IRT/EDCResolved | Low | STUDY-0003
REC-000004 | eCOA/LabOpen | Critical | STUDY-0004
REC-000005 | Lab/eCOAEscalated | Low | STUDY-0005
REC-000006 | EDC/EDCEscalated | High | STUDY-0006
REC-000007 | EDC/LabIn Review | Critical | STUDY-0007
REC-000008 | eCOA/IRTResolved | Critical | STUDY-0008
REC-000009 | IRT/EDCOpen | High | STUDY-0009
REC-000010 | EDC/eCOAIn Review | Medium | STUDY-0010
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.