🛕 SOC within MedDRA: Key Insights

This blog covers the following topics:

1. Understanding SOC (System Organ Class)
2. Key Components of SOC
3. The Importance of SOC in MedDRA Coding

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.

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.

1. Blood and lymphatic system disorders
2. Cardiac disorders
3. Congenital, familial and genetic disorders
4. Ear and labyrinth disorders
5. Endocrine disorders
6. Eye disorders
7. Gastrointestinal disorders
8. General disorders and administration site condition
9. Hepatobiliary disorders
10. Immune system disorders
11. Infections and infestations
12. Injury, poisoning and procedural complications
13. Investigations
14. Metabolism and nutrition disorders
15. Musculoskeletal and connective tissue disorders
16. Neoplasms benign, malignant and unspecified (incl cysts and polyps)
17. Nervous system disorders
18. Pregnancy, puerperium and perinatal conditions
19. Product issues
20. Psychiatric disorders
21. Renal and urinary disorders
22. Reproductive system and breast disorders
23. Respiratory, thoracic and mediastinal disorders
24. Skin and subcutaneous tissue disorders
25. Social circumstances
26. Surgical and medical procedures
27. 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

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!