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MedDRA Basics and Interview Questions
Q: What is MedDRA?
A: Medical Dictionary for Regulatory Activities
Q: When MedDRA was adopted by ICH?
A: October 1994 – ICH adopted MEDDRA Version 1.0 as basis for international terminology
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Q: Why MedDRA has been designed?
A: ICH endeavours to provide a single standardised international medical terminology which can be used for regulatory communication and evaluation of data pertaining to medicinal products for human use.
The need for a standardised medical terminology was identified by the ICH in the 1990s since there was not a standard terminology available that provided the scope and level of granularity needed by regulatory authorities and industry.
As a result, MedDRA is designed for use in the registration, documentation and safety monitoring of medicinal products through all phases of the development cycle.
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Q: How often MedDRA will be updated?
A: MedDRA updates are bi-annual with the first release in March and the second in September.
Q: Why and for what to code, MedDRA is used?
A: A terminology for coding all medical information obtained during all phases of development and marketing.
- Symtoms
- Signs
- Diseases
- Dignoses
- Indications
- Investigations/Procedures
- Medical/Social History
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Q: Who developed MedDRA?
A: MedDRA been developed by ICH.
Medical Dictionary for Regulatory Activities. MedDRA is a rich and highly specific standardised medical terminology developed by ICH to facilitate sharing of regulatory information internationally for medical products used by humans
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Q: What is MedDRA Hierarchy?
A: The structure of MedDRA is very logical. There are five levels to the MedDRA hierarchy, arranged from very specific to very general.
- “Lowest Level Terms” (LLTs),
- “Preferred Terms” (PTs),
- “High Level Terms” (HLTs),
- “High Level Group Terms” (HLGTs),
- “System Organ Classes” (SOCs)
Q: Count of SOCs, HLGTs, HLTs, PTs and LLTs in MedDRA?
A: There are
- SOC – 27
- HLGT – 337
- HLT – 1737
- PT – 24289
- LLT – 81812
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Q: MedDRA Codes example?
| Term | code |
| Gastric hemorrhage (LLT) | 10017789 |
| Gastric haemorrhage (PT) | 10017788 |
| Gastric and oesophageal haemorrhages (HLT) | 10017751 |
| Gastrointestinal haemorrhages (HLGT) | 10017959 |
| Gastrointestinal disorders (SOC) | 10017947 |
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Q: How to take subscription for MedDRA?
A: If your organisation is headquartered in Japan, please contact the Japanese Maintenance Organization at https://www.jmo.pmrj.jp, otherwise continue to Steps as below.
- Determine the type of subscription applicable for your organisation.
- Determine the rate that is applicable for the subscription type.
- Complete the online subscription form.
- If you are requesting a commercial subscription, please upload an annual report or a signed statement from your organisation on letterhead describing total revenue or turnover for its most recently completed fiscal year.
- Your subscription includes English and all translations.
- Submit your online subscription form.
- You may save or print a copy of the completed subscription form after submission.
- The MSSO will email an invoice to the designated billing point of contact for payment if applicable. Upon receipt of payment, the MSSO will provide the information to download MedDRA.
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Q: What is MSSO?
A: Maintenance and services support organization
Q: Inner view of MSSO and MedDRA
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