The 27 System Ogran classes (MedDRA)


This post is part of 'Domain | General' series

The MedDRA system organ class is defined as the highest level of the MedDRA terminology, distinguished by anatomical or physiological system, aetiology (disease origin) or purpose. Most of these describe disorders of a specific part of the body. For example:

  • Cardiac disorders describe heart problems
  • Renal and urinary disorders describe kidney and bladder problems
  • Some of the system organ classes are not related to a particular part of the body. For example:
    • investigations describes laboratory tests and other medical investigations that gave an unusual reading
    • neoplasms describes any type of growth, including cancer, no matter where it appears in the body.
  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 conditions
  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. Psychiatric disorders
  20. Renal and urinary disorders
  21. Reproductive system and breast disorders
  22. Respiratory, thoracic and mediastinal disorders
  23. Skin and subcutaneous tissue disorders
  24. Social circumstances
  25. Surgical and medical procedures
  26. Vascular disorders
  27. Product issues.




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General
What is MedDRA
What is WHO-DD
What is ATC classification of Drugs
Tables vs Listings in Clinical Trial Analysis
Analysis Sets in Clinical Trial Data Analysis
Validation of TFLs in Clinical Trials
Vital Signs in Clinical Trials
ECG in clinical trials
Solid tumors vs other cancers
What is 21 CFR Part 11?
Declaration of Helsinki
Importance of Harmonization (ICH)
The Drug development process
Overview of clinical trial process
What is a clinical trial?
What is Pinnacle 21?
Who conducts clinical trials?
Why are clinical trials conducted?
What are the phases of clinical trials?
Why are oncology clinical trials considered critical?
What is a clinical trial protocol?
Case Report Form (CRF)
Database annotated CRF
What is a clinical trial registry?
Factors affecting drug metabolism and activity
Prior and Concomitant medications
Inclusion/Exclusion Criteria in a clinical trial
What happens after a clinical trial is completed?
The Investigational New Drug Process
Preclinical Research
Drug discovery
FDA Drug Review
What is the importance of baseline characteristics in a clinical trial?
Why do we need CDISC standards?
What is a clinical development plan?
What is a clinical study report?
"Exploratory study" vs "Confirmatory study"
What is ICH?
Clinical trial registries
Efficacy data vs Safety data
What is clinical data management?
Clinical SAS Programmer
Statistical Analysis Plan
The 27 System Ogran classes (MedDRA)
What is RECIST 1.1?

Trial design aspects
What is a crossover clinical trial?
What is blinding in clinical trials?
What is an open-label clinical trial?
What is randomization in clinical trials?

Terminology
What is a cohort?