auditable.

Version control: Whether coding aligns with the correct MedDRA version at the time.

Training: Whether coders and CRAs received adequate MedDRA training.

Reconciliation: Whether coding is reconciled across databases (CRFs, safety databases, TMF).

For example, an audit may review whether all cases of “fits” were consistently coded as “Convulsion” across multiple Phase II and III trials. Inconsistencies may suggest lack of coding conventions or inadequate coder training.

Common Audit Findings in MedDRA Coding

Across inspections and audits, recurring findings include:

• Incorrect PT selection due to ambiguous verbatim terms.
• Inconsistencies across coders or studies for the same term.
• Lack of documentation explaining coding choices.
• Failure to update coding after MedDRA version upgrades.
• Insufficient training of coders and CRAs in MedDRA basics.
• Delayed reconciliation between CRFs, safety databases, and narratives.

These issues highlight the importance of robust SOPs, coder training programs, and internal audits before regulatory inspections. Regulators frequently note that coding errors compromise pharmacovigilance reliability and may issue critical findings if systemic weaknesses are identified.

Case Study: Audit Review of Psychiatric Coding

In one Phase III antidepressant trial, auditors reviewed how suicidal ideation was coded. Investigators used terms like “patient talked about death” and “wants to die.” Coders inconsistently applied PTs—some used “Depression,” while others applied “Suicidal ideation.”

The audit team identified this inconsistency as a major finding because suicidality requires expedited reporting under global regulations. The sponsor was instructed to reconcile all prior data, retrain coders, and revise SOPs to explicitly define how suicidality terms should be coded. This case demonstrates how errors in psychiatric coding can escalate into regulatory risk.

Reconciliation During MedDRA Coding Audits

Auditors pay close attention to reconciliation of safety data across systems. For instance:

• CRF vs Safety Database: AE terms in CRFs must match those in the pharmacovigilance database.
• Narratives vs MedDRA Coding: Narrative descriptions must align with PT assignments.
• Version Updates: Recoding after MedDRA version changes must be documented.

Lack of reconciliation is often cited as a critical finding because it creates discrepancies in safety reporting to regulators. Sponsors must maintain detailed reconciliation logs and demonstrate periodic checks to auditors.

Regulatory Expectations During Inspections

Agencies expect sponsors to demonstrate that MedDRA coding processes are:

• Standardized: Clear SOPs define how coders handle ambiguous terms.
• Documented: Coding decisions include rationale in audit trails.
• Consistent: Coders across studies follow the same conventions.
• Version-aligned: Coding reflects the MedDRA version in use at the time of the event.
• Training-supported: Coders, CRAs, and safety staff maintain competency through training logs.

For example, the ANZCTR emphasizes harmonized AE reporting standards, which rely on consistent MedDRA coding practices. Inspectors expect sponsors to align with such international expectations.

Best Practices for Audit Readiness in MedDRA Coding

To prepare for audits and inspections, sponsors should implement:

• Comprehensive SOPs: Define coding rules, version updates, and reconciliation steps.
• Coder training: Conduct regular training and assessments for coders and CRAs.
• Internal audits: Perform mock audits focused on coding accuracy and traceability.
• Reconciliation logs: Maintain detailed logs comparing CRFs, narratives, and safety databases.
• Version management: Document how MedDRA updates were implemented.

These practices strengthen inspection readiness, minimize findings, and ensure that safety data is accurate and reliable across global submissions.

Key Takeaways

MedDRA coding reviews during audits are a critical part of pharmacovigilance oversight. Clinical teams must:

• Ensure accuracy, consistency, and traceability in MedDRA coding.
• Document coding conventions, training, and reconciliation processes.
• Conduct internal audits to detect and correct errors proactively.
• Prepare audit-ready evidence of version control and SOP compliance.

By adopting strong audit readiness practices, sponsors can demonstrate compliance, maintain regulatory trust, and ensure reliable pharmacovigilance across clinical development programs.