This blog post offers essential insights on:
- Efficient utilization and coding with MedDRA
- A comprehensive, step-by-step guide supplemented with reference images
- Practice links for honing MedDRA coding skills and attaining proficiency.
Table of Contents:
- Introduction
- Definitions
- Scope of MedDRA
- Best Practices to Follow in MedDRA Coding
- Bonus Tips
- Closing Thoughts
- FAQ
Introduction
MedDRA – Medical Dictionary for Regulatory Activities
MedDRA serves as a comprehensive reference library/dictionary encompassing a wide range of coded terms for various regulatory purposes. These encompass medical conditions, laboratory results, surgical procedures, and all therapeutic interventions.
Definitions:
MedDRA
MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated bio-pharmaceutical industry. The terminology is used through the entire regulatory process, from pre-marketing to post-marketing, and for data entry, retrieval, evaluation, and presentation.
I recommend to explore our previous discussion on the crucial role of regulatory bodies in ensuring public safety.
MedDRA coding
MedDRA coding is distinct process from technical coding; it involves selecting the precise or closest matching term from the MedDRA library that corresponds to the reported context.
Scope of MedDRA
Given its importance in regulatory activities, MedDRA stands out as the foremost dictionary utilized in this field. Its widespread adoption underscores its efficacy in managing tasks relevant to regulatory authorities.
The MedDRA coding is a process must complete and match by selecting most closest term to the reported verbatim.
What is verbatim?
The term “verbatim” refers to a word-for-word, exact, or literal representation of something, such as text, speech, or a statement.
In various contexts, “verbatim” is used to emphasize accuracy and fidelity to the original source. For example:
- Verbatim Transcript: A transcript that records spoken words exactly as they were spoken, without any edits or alterations.
- Verbatim Quotation: When you quote someone verbatim, you are using their exact words without any changes.
- Verbatim Copy: A copy of a document or text that replicates the original without any modifications.
Precision in MedDRA coding procedures is the cornerstone of accurate medical data analysis.
Enhance your skills in MedDRA with Drugvigil
Here are best practices to follow in MedDRA coding:
1. Start with a clear understanding of reported verbatim:
Begin by understanding the distinctions between medical conditions, adverse events, and signs and symptoms. Consult the internal medical team for further clarification rather than simply coding based on reported information.
📢 Eager to delve deeper into this section, particularly in elucidating the distinction between medical history and adverse events.
2. Right diagnosis:
Do not make diagnosis if only signs/symptoms reported.
3. Skill with Online Searches:
Develop the ability to identify credible websites and avoid chat forums for reference. Reliable sources are essential for accurate coding.
4. Verbatim in Procedures and Investigations:
Understand the nuances between verbatim terms in procedures, investigations, and other events. Ensure accurate coding by recognizing these differences.
5. Understanding Verbatim to SOC Level:
Analyze and able to understand the reported verbatim terms and categorize them under the appropriate broad System Organ Class (SOC).
Tip: Use search engines to clarify the organ class when needed. To learn more about hierarchy of MedDRA check our previous editions by clicking the highlighted link.
- Example: Understanding the difference between traumatic vs, pathological etiologies of various conditions.
- Analysing the body site conventions in SOC assignment (e.g., Chest wall = Musculoskeletal).
- Understanding the difference between traumatic vs, pathological etiologies of various conditions, and where to find those terms (e.g., Broken arm from fall vs. Pathologic fracture of humerus)
6. Start select coding at LLT level:
Start your coding selection process at the Lowest Level Term (LLT) level. Begin from the bottom, moving upwards, filtering, and finalizing your selection by choosing the code that aligns with the already concluded System Organ Class (SOC).
7. Find the closest LLT:
When faced with multiple possibilities (minimum 3 to 4) for LLTs (Lowest Level Term), consult or search to code the most appropriate term.
- Example #1: Choosing between “Macular rash,” “Stoma site rash,” or “Urinary tract stoma complication” for a verbatim like “Macular rash at nephrostomy site”.
- Example #2: Addict vs. Addiction; Menopause vs. Menopausal symptoms – when the LLTs in Social Circumstances are appropriate to code to – No Social Circumstance LLTs in AEs.
- Example #3:
8. Select Code Progressively:
When starting from the Lowest Level Term (LLT), make sure to narrow down your options to the System Organ Class (SOC) by determined through the Preferred Term (PT).
✍️ Note:
- PT (Preferred terms) are typically used in the E2B format.
- Note that, PTs represented in only one SOC are automatically assigned that SOC as primary.
I encourage you to explore our previous edition of blog, where we delve deep into the topic of E2B, offering comprehensive insights.
- Caution: It should exercise when coding preferred terms (PTs) in MedDRA coding, especially when dealing with multi-axial terminologies. Multi-axial terminologies refer to situations where a single PT (preferred term) may assign to more than one System Organ Class (SOC). An example of this can be found below for reference:
- Example #1: A preferred term like “Headache” may assign to both the “Nervous system disorders” SOC and the “Vascular disorders” SOC in MedDRA coding.
- Example #2:
9. Selecting Non-current terms in LLT
Selecting non-current Lowest Level Terms (LLT) only in specific cases.
- Flagged at the LLT level in MedDRA.
- Not recommended for continued use (Meant the code).
- Retained to preserve historical data for retrieval and analysis.
- Terms that are vague, ambiguous, out-dated, truncated, or misspelled.
- Terms derived from other terminologies that do not fit MedDRA rules.
10. Coding for Procedures and Investigations:
Consider a laboratory test as an adverse event only when its data holds significance in the investigation.
Indeed, MedDRA can assist in coding investigation data and procedures.
11. Applying Medical Judgment:
If no exact match in MedDRA, use medical judgment to match to an existing term that adequately represents the concept.
By following these best practices, you can enhance your proficiency in MedDRA coding and ensure the accurate classification of medical terms and events with minimising coding errors.
Bonus tips:
Proficiency with using the MedDRA browser if you have an access to one (e.g., limiting search to a certain SOC; searches with word stems; use of medical equivalents; top/down vs. bottom/up searches).
Familiarity with the MedDRA browser can streamline the coding process and improve accuracy.
- If you wish to familiar with MedDRA coding considering take advantage of MSSO training, webinars and video-casts here: https://www.meddra.org/training/schedule
- If you wish to know more about MedDRA classes and terms click link here: https://bioportal.bioontology.org/ontologies/MEDDRA
- Interactive MedDRA Training Course Now Accessible at: MedDRA free interactive training.
- You can access the MedDRA web browser here: MedDRA web browser. (Subscription required)
Closing thought
Some may perceive this as a straightforward task, but it’s important to recognize that numerous errors can occur due to incorrect coding of events in the database. Learning from these experiences can contribute to the improvement of your future processes, and I would be glad if it proves beneficial.
Have I overlooked any crucial elements in MedDRA coding? Let me know in the comments, if there are any omissions.
FAQ:
What is MedDRA
What is Verbatim?
What are the three type of verbatim?
2. Verbatim Quotation
3. Verbatim Copy
Where i can learn MedDRA coding for free of cost?
2. https://bioportal.bioontology.org/ontologies/MEDDRA
3. MSSO training, webinars and video-casts here: https://www.meddra.org/training/schedule
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