Japanese Translation of MedDRA Terms

May 20, 2005

1. Background

The MedDRA Japanese translation is provided as a bilingual(English-Japanese)dictionary to its subscribers. Under these circumstances, it is ideal that all English terms, which are linguistically unique from SOC through LLT level, are translated into all unique Japanese counterparts. This is, however, very difficult in reality because of cultural and linguistic differences. The MedDRA Japanese translation has been, therefore, allowed to give the same Japanese translation to different English terms placed in LLT level. This, in turn, means that the same Japanese terms exist with different MedDRA code # and different English descriptions. As it is thought that keeping Japanese terms unique to one another is essential to keep consistency in data, MedDRA/J currency flags are granted to Japanese terms for keeping Japanese uniqueness.

2. Duplicate Japanese translations are given to those terms shown below:

   1.   British vs. American spelling; e.g., Oedema vs. Edema

   2.    Full spelled term vs. abbreviation; e.g., Malnutrition protein-calorie vs. PCM

   3.    Singular forms vs. plural forms; e.g., Foot vs. Feet

   4.    Terms differ only in word order; e.g., Liver disorder vs. Disorder liver

   5.    Terms coming from different origin with same meaning; e.g., Headache vs. Cephalgia

   6.    Some layman terms; e.g., Dizziness upon standing vs. Dizzy on standing

   7.    Some noun forms vs. adjective forms; e.g., Blindness vs. Blind

3. MedDRA Japanese translation Currency flag

All Japanese LLTs have Japanese Currency flags “Y”(current) or “N”(non-current)

Japanese Currency flag “Y” is given to:

· J-LLTs which have unique Japanese translation (i.e., no other terms have the same Japanese translation)

· A single J-LLT selected from a group of J-LLTs which have the same Japanese translation

Japanese Currency flag “N” is given to:

· J-LLTs which correspond to non-current English terms

· J-LLTs which have identical Japanese translations to a term with flagged “Y” in Japanese Currency flag

4. Priority for granting MedDRA Japanese translation Currency flag “Y”

Each item number (1~7) corresponds to that of Item 2. (above)

When the MedDRA Japanese translation Currency flag is undecided based on the above priority, additional consideration is given to:

· Order in reference in Japanese Medical Terminology [Japanese-English]

5. Exceptions

Some HLGTs and HLTs have the same Japanese translation with PTs due to their difference only in a form (i.e., singular vs. plural form).

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