Clinical Trials: MedDRA Coding of Events

What is MedDRA and Why is it Used in Clinical Trials?

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The Medical Dictionary for Regulatory Activities (MedDRA) is an internationally standardized medical terminology developed under the auspices of the International Council for Harmonisation (ICH). It is the global standard for coding adverse events, medical histories, indications, and procedures across clinical trials and post-marketing surveillance. Regulators such as the FDA, EMA, MHRA, PMDA, and CDSCO require the use of MedDRA for consistent reporting of adverse events.
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Adverse Event Reporting and Management, MedDRA Coding of Events

Hierarchy of MedDRA Terms: From LLT to SOC

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The Medical Dictionary for Regulatory Activities (MedDRA) is a standardized terminology used globally to code adverse events in clinical trials and post-marketing surveillance. One of its most powerful features is its hierarchical structure, which allows for flexible analysis of safety data. The hierarchy ranges from very specific patient-reported terms (Lowest Level Terms, LLTs) to broad categories used in regulatory summaries (System Organ Class, SOC).
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Adverse Event Reporting and Management, MedDRA Coding of Events

Choosing the Right Preferred Term (PT) in MedDRA Coding

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The Preferred Term (PT) is the cornerstone of MedDRA coding in clinical trials and pharmacovigilance. Each PT represents a unique medical concept that enables harmonized reporting of adverse events across studies and regions. The correct choice of PT ensures regulatory compliance, supports accurate signal detection, and allows for meaningful safety analysis. Conversely, misclassification at the PT level can lead to erroneous safety conclusions, missed signals, or regulatory findings during inspections.
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Adverse Event Reporting and Management, MedDRA Coding of Events

Auto-coding vs Manual Coding in MedDRA: Risks and Benefits

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Adverse event reporting in clinical trials depends heavily on MedDRA coding. Coders and pharmacovigilance staff transform investigator-reported verbatim terms into standardized Lowest Level Terms (LLTs) and Preferred Terms (PTs). Two primary approaches exist: auto-coding and manual coding. Both methods are widely used, and most sponsors employ a hybrid approach to balance efficiency and accuracy.
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Adverse Event Reporting and Management, MedDRA Coding of Events

Coding of Events with Ambiguous Verbiage in MedDRA

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In clinical trials, adverse events (AEs) are initially reported by investigators in verbatim language, often reflecting patient statements or clinical notes. These terms are not always precise. Ambiguous expressions such as “feeling unwell,” “stomach upset,” or “heart problem” pose significant challenges during MedDRA coding. Unlike clear terms like “myocardial infarction” or “rash,” ambiguous terms require coder interpretation, which increases the risk of misclassification and regulatory non-compliance.
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Adverse Event Reporting and Management, MedDRA Coding of Events

How to Handle Updates in MedDRA Versions

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The Medical Dictionary for Regulatory Activities (MedDRA) is updated twice a year—typically in March and September. These updates ensure that the dictionary evolves with medical science, incorporating new terms, restructuring hierarchies, and refining definitions. For sponsors, CROs, and regulators, version updates improve data accuracy, harmonize coding, and support signal detection across therapeutic areas.
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Adverse Event Reporting and Management, MedDRA Coding of Events

Coding Challenges in Psychiatric Events Using MedDRA

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Psychiatric adverse events present unique challenges in clinical trials. Unlike physical conditions, psychiatric events are often reported with subjective terminology, varied cultural interpretations, and overlapping symptomatology. Using MedDRA (Medical Dictionary for Regulatory Activities) to code psychiatric events requires coders to balance accuracy, consistency, and clinical judgment. Regulators such as the FDA, EMA, MHRA, and CDSCO expect sponsors to demonstrate traceable and consistent approaches when handling psychiatric adverse events (AEs) and serious adverse events (SAEs).
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Adverse Event Reporting and Management, MedDRA Coding of Events

Training Clinical Research Associates (CRAs) on MedDRA Basics

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Clinical Research Associates (CRAs) play a central role in ensuring data quality in clinical trials. While CRAs are not typically responsible for the final coding of adverse events, they are the primary link between investigative sites and sponsors. Their ability to understand the basics of MedDRA (Medical Dictionary for Regulatory Activities) directly impacts the accuracy of adverse event (AE) reporting and the integrity of pharmacovigilance data.
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Adverse Event Reporting and Management, MedDRA Coding of Events

MedDRA Coding Review During Audits

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MedDRA (Medical Dictionary for Regulatory Activities) coding is a cornerstone of adverse event reporting in clinical trials. During regulatory inspections and internal audits, coding processes are carefully reviewed to ensure accuracy, traceability, and compliance. Regulators such as the FDA, EMA, MHRA, and CDSCO recognize that coding errors can distort safety signal detection, compromise pharmacovigilance, and lead to misleading regulatory submissions such as DSURs and PSURs.
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Adverse Event Reporting and Management, MedDRA Coding of Events

SAE Coding Case Studies and Examples Using MedDRA

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Serious Adverse Events (SAEs) represent critical data points in clinical trials and pharmacovigilance. Regulatory authorities such as the FDA, EMA, and MHRA require accurate and consistent coding of SAEs using the Medical Dictionary for Regulatory Activities (MedDRA). Proper coding ensures that safety signals are identified, analyzed, and reported in compliance with global regulatory expectations.
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Adverse Event Reporting and Management, MedDRA Coding of Events