This blog covers the following topics:
- Understanding SOC (System Organ Class)
- Key Components of SOC
- The Importance of SOC in MedDRA Coding
Table of Contents
Introduction
As healthcare professionals, you’re likely familiar with MedDRA, or at least have heard of it. For pharmacovigilance professionals, We’ve covered MedDRA detailing in with a dedicated MedDRA series.
In this post, we’re going to explore one of the key hierarchies within MedDRA: SOC (System Organ Class). Let’s dive in and understand its significance.
SOC: A Comprehensive Overview
SOC is a single-axis classification, meaning the terms within each SOC are exclusive to that category and are not linked to any other SOCs in MedDRA. The next level in the MedDRA hierarchy is HLGT (High-Level Group Term).
SOC represents a higher level in the MedDRA hierarchy, organized based on systems and organs in the human body.
Each SOC classified carefully based anatomical, pathological, or etiological factors.
“System Organ Classes (SOC) in MedDRA serve as the foundation for organizing adverse events, categorizing them by body systems and organs to bring clarity and precision to clinical data.”
SOC: Its Core Components Explained
Below are the list of SOC that are divided in to 27 components. Each of the divisions below is further classified into its own HLGT levels.
- Blood and lymphatic system disorders
- Cardiac disorders
- Congenital, familial and genetic disorders
- Ear and labyrinth disorders
- Endocrine disorders
- Eye disorders
- Gastrointestinal disorders
- General disorders and administration site condition
- Hepatobiliary disorders
- Immune system disorders
- Infections and infestations
- Injury, poisoning and procedural complications
- Investigations
- Metabolism and nutrition disorders
- Musculoskeletal and connective tissue disorders
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Nervous system disorders
- Pregnancy, puerperium and perinatal conditions
- Product issues
- Psychiatric disorders
- Renal and urinary disorders
- Reproductive system and breast disorders
- Respiratory, thoracic and mediastinal disorders
- Skin and subcutaneous tissue disorders
- Social circumstances
- Surgical and medical procedures
- Vascular disorders
Search Strategies
Search strategies often rely on SOC, especially when you know the specific system involved in the reported adverse event.
For example, if the goal is to conduct a search that covers various types of blood disorders, such as anemias or “bleeding diatheses,”. Here multiple HLGTs need to be considered, as the relevant terms are grouped under different categories. So here SOC plays a role as primary selection.
SOC: The Hierarchical significance
Many overlook the importance of SOC during coding. It’s crucial to ensure that the closest LLTs categorized under the correct system class according to the report.
In some cases, an LLTs may appear under multiple SOCs. Blindly coding based only on the LLT can have assigned to the wrong system, rather than the one actually reported.
Key Takeaways
SOCs are organized based on systems and organs, reflecting the occurrence of adverse events.
There are currently 27 SOCs, each carefully classified to ensure comprehensive coverage.
These 27 SOCs are clearly defined, encompassing systems, organs, as well as investigations and product complaints.
SOCs follow a single-axis search strategy, simplifying the classification process.
SOC is the top level in the MedDRA hierarchy and contains the fewest terms compared to other levels.
Conclusion
This write-up provides a brief overview of MedDRA, with a particular focus on SOC. As a key element in MedDRA’s hierarchy, SOC plays a crucial role in organizing adverse event data.
Do you think we missed anything important?
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Thanks for reading!
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