Tag: All about ICSR processing
Within this tag, you will discover a complete repository of information pertaining to ICSR (Individual Case Safety Report) cases, presented systematically from top to bottom at each level.
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Adverse Event Coding: Signs and Symptoms
This blog covers: Introduction Pharmacovigilance coding involves several complex and often confusing areas, including indications, adverse events, and current conditions. In this article, we will explore how signs, symptoms, and adverse events are identified, evaluated, and coded into a safety database, along with best practices for accurate and consistent reporting. Signs and symptoms: An overview…
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Warnings and Precautions: Key Insights from Safety Documents
This article explores how the Warnings and Precautions section of safety documents plays a critical role in this process. Let’s dive in and explore.
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Action Taken and Outcome: Explained
This comprehensive blog will guide you through the fundamentals of “action taken” in case files and its impact on patient outcomes, highlighting their interrelation.
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Condition aggravated: A scenario
Understanding how to handle condition aggravated as reported as an adverse event is a common challenge in pharmacovigilance case processing. Let’s dive in.
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Current and Non-Current LLTs in MedDRA
This comprehensive artcile detailed article explained often overlooked but essential for quality data in MedDRA coding. That is Current and Non-Current LLTs.
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Decoding Why Severe Isn’t Always Serious
This article demystifies the distinction between the two, the terms why severe isn’t always serious are often misunderstood—and mistakenly used interchangeably.
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Death: An Adverse Event
This blog features: Introduction This comprehensive article explores how to handle fatal cases, which are classified under the serious criteria in pharmacovigilance. It also highlights special scenarios related to managing death cases during ICSR case processing. Consider this your go-to guide to ensure you never overlook important pharmacovigilance conventions when handling such critical reports. Death…
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From Start to Finish: Data-Entry in Pharmacovigilance
In this comprehensive blog discussing data entry into databases, we will explore essential factors to consider and apply when dealing with Adverse Event coding. Check this out.
