Adverse Event Reporting and Management

Avoiding Reporting Delays in Expedited SAE Submissions: Best Practices

Posted on digi By digi

Timely reporting of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) is one of the most critical regulatory obligations in clinical trials. Agencies such as the FDA, EMA, MHRA, and CDSCO enforce strict expedited reporting timelines: 24 hours for investigator-to-sponsor notification, 7 days for fatal/life-threatening SUSARs, and 15 days for all other SUSARs. Any delay jeopardizes patient safety, undermines trial credibility, and exposes sponsors to regulatory actions including FDA Form 483s, clinical holds, and EMA inspection findings.
Click to read the full article.

Adverse Event Reporting and Management, Expedited Reporting Timelines

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

Posted on digi By digi

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.
Click to read the full article.

Adverse Event Reporting and Management, MedDRA Coding of Events

Hierarchy of MedDRA Terms: From LLT to SOC

Posted on digi By digi

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).
Click to read the full article.

Adverse Event Reporting and Management, MedDRA Coding of Events

Choosing the Right Preferred Term (PT) in MedDRA Coding

Posted on digi By digi

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.
Click to read the full article.

Adverse Event Reporting and Management, MedDRA Coding of Events

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

Posted on digi By digi

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.
Click to read the full article.

Adverse Event Reporting and Management, MedDRA Coding of Events

Coding of Events with Ambiguous Verbiage in MedDRA

Posted on digi By digi

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.
Click to read the full article.

Adverse Event Reporting and Management, MedDRA Coding of Events

How to Handle Updates in MedDRA Versions

Posted on digi By digi

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.
Click to read the full article.

Adverse Event Reporting and Management, MedDRA Coding of Events

Coding Challenges in Psychiatric Events Using MedDRA

Posted on digi By digi

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).
Click to read the full article.

Adverse Event Reporting and Management, MedDRA Coding of Events

Training Clinical Research Associates (CRAs) on MedDRA Basics

Posted on digi By digi

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.
Click to read the full article.

Adverse Event Reporting and Management, MedDRA Coding of Events

MedDRA Coding Review During Audits

Posted on digi By digi

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.
Click to read the full article.

Adverse Event Reporting and Management, MedDRA Coding of Events