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'''System Organ Class (SOC)''' is a hierarchical classification system used in the field of [[pharmacovigilance]] and [[clinical trials]] to categorize the nature of [[adverse event]]s reported in the development, testing, and post-marketing surveillance of [[pharmaceuticals]]. The SOC system is part of the [[Medical Dictionary for Regulatory Activities]] ([[MedDRA]]), which is a globally accepted standard for the classification of medical information related to regulatory activities and safety reporting.

==Overview==
The SOC classification organizes adverse events into groups based on the biological system or organ class that they affect. This system allows for a systematic tracking and analysis of adverse events, facilitating the identification of potential safety signals and trends that may be associated with the use of a particular drug or therapeutic intervention.

==Structure==
The SOC hierarchy is structured into several levels, with the top level being the system organ class itself. Each SOC is divided into [[High-Level Group Terms]] (HLGTs), which are further subdivided into [[High-Level Terms]] (HLTs). Below HLTs are [[Preferred Terms]] (PTs), which describe specific adverse events. At the lowest level of the hierarchy are the [[Lowest Level Terms]] (LLTs), which are synonyms or lexical variants of the PTs.

==Common System Organ Classes==
Some of the major system organ classes include, but are not limited to:
* [[Cardiac disorders]]
* [[Gastrointestinal disorders]]
* [[Nervous system disorders]]
* [[Psychiatric disorders]]
* [[Respiratory, thoracic and mediastinal disorders]]
* [[Skin and subcutaneous tissue disorders]]

==Usage==
SOCs are used extensively in the regulatory submission of drugs for approval, in the ongoing monitoring of drug safety post-approval, and in the conduct of clinical trials. They provide a standardized language that facilitates the communication of safety information among healthcare professionals, regulatory authorities, and the pharmaceutical industry.

==Advantages==
The use of SOCs and the broader MedDRA system offers several advantages:
* Standardization of terminology, which reduces ambiguity in adverse event reporting.
* Facilitation of the global exchange of safety information.
* Ability to track and analyze trends in adverse event reporting over time.

==Challenges==
Despite its advantages, the use of the SOC system also presents challenges:
* The broad categories of SOCs can sometimes obscure the specific nature of an adverse event.
* The hierarchical structure requires careful navigation to ensure accurate coding of adverse events.

==Conclusion==
The System Organ Class classification within MedDRA is a critical tool in the field of pharmacovigilance, offering a structured approach to the categorization and analysis of adverse events. Its widespread adoption underscores its value in promoting drug safety and protecting public health.

[[Category:Pharmacology]]
[[Category:Clinical research]]
[[Category:Medical terminology]]

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System Organ Class - Revision history

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