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A practical guide to MedDRA upgrades, quality checks, and controls.
Plan version upgrades with risk-based change control
MedDRA evolves continuously, which is great for signal sensitivity but risky if upgrades are unmanaged. Begin with a lightweight risk assessment for each release: what product portfolios, regions, and workflows are affected; which SMQs change; and where coding concordance might shift. Establish a versioning policy that defines which releases you adopt (March and/or September), the decision cadence, and the sandbox process for testing impacts. Maintain a canonical mapping of dictionaries used across systems (safety database, clinical data management, signal tools) and require synchronized upgrades to avoid cross‑system mismatches. Create a change control package for every upgrade: scope, rationale, risk assessment, test plan, and rollback. Pull authoritative references into the pack so reviewers can navigate quickly—start at the MedDRA site’s versioning overview at MedDRA versioning, and include relevant “What’s New” and release notes. For background on how change requests shape terminology, attach the MSSO’s change‑request guide at MSSO change request info. Define owners for medical review, coding operations, signal analytics, and system validation so responsibilities are explicit.
Execute validation, routing, and reconciliations reliably
Validation should be layered and evidence‑rich. Start with a regression suite of representative cases covering common terms, critical events, and known edge cases; re‑generate E2B(R3) messages in a sandbox and verify schema validity, controlled vocabulary alignment, and routing headers.
Compare coded outputs across old and new versions to quantify concordance: where PTs or LLTs shift, confirm medical appropriateness and document rationale for any re‑coding.
Verify SMQ‑based signal monitors and case series logic under the new version and adjust thresholds if detection volumes change materially. Maintain acknowledgments (ACK/NAK) logs and error payloads during test submissions to confirm replay‑safe behavior and avoid duplicates on go‑live.
Synchronize versions across systems. Align upgrades among safety, clinical data management, and analytics tools to prevent version drift that can corrupt reconciliations or degrade signal detection.
Keep a dictionary inventory that includes versions, effective dates, owners, and downstream dependencies. For teams new to structured version management, the MedDRA site provides central resources and learning materials at MedDRA.
Measure impact and sustain compliance over time
Sustained compliance requires measurement and governance after go‑live. Track KPIs such as coding concordance versus prior version, first‑pass case quality, volume of re‑coded terms, false positive/negative rates in SMQ screens, and authority acknowledgment latency.
Provide role‑based dashboards for safety physicians, case processors, QA, and system owners so each has visibility into impacts that matter to them. Keep an auditable record of who approved the upgrade, when it went live, which test evidence supported the decision, and how any deviations were handled. Plan for continuous improvement.
Maintain a backlog of terminology pain points and submit change requests to the MSSO when appropriate; the submission process and timelines are summarized in the “Change Request Information” document at MSSO change request info.
Revisit detection thresholds and case quality checklists after each upgrade to account for behavioral shifts in coding. By treating MedDRA versioning as structured change control—anchored in authoritative references and measured in production—you reduce disruption, protect signal quality, and strengthen inspection readiness.
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