Information about the Japanese Translation of MedDRA For questions concerning the Japanese translation of MedDRA (MedDRA/J) – if not addressed in this document – please contact the JMO Help Desk Email for JMO Subscribers: [email protected] Email for Non-JMO Subscribers: [email protected] Duplicate Japanese Translations The MedDRA Japanese translation (MedDRA/J), maintained by the Japanese Maintenance Organization (JMO), is provided as a bilingual (English-Japanese) terminology. All linguistically unique English terms, from SOC to LLT level, are translated into unique Japanese counterparts. Because of cultural and linguistic differences, MedDRA/J gives the same Japanese translation to different English terms at the LLT level. This means that the same Japanese term exists with different MedDRA code numbers and different English descriptions. Keeping Japanese terms unique from one another is essential to retain consistency of data, and therefore, MedDRA/J currency flags are assigned to Japanese terms to support Japanese “uniqueness” (see below); note that this “currency flag” approach is used only for the Japanese translation. Duplicate Japanese translations are assigned to the following types of English MedDRA terms: 1. 2. 3. 4. 5. 6. 7. British vs. American spelling; e.g., Oedema vs. Edema Fully spelled term vs. abbreviation; e.g., Malnutrition protein-calorie vs. PCM Singular forms vs. plural forms; e.g., terms with “foot” vs. “feet” Terms that differ only in word order; e.g., Liver disorder vs. Disorder liver Synonyms with different origins; e.g., Headache vs. Cephalgia Some lay expression terms; e.g., Dizziness upon standing vs. Dizzy on standing Some noun forms vs. adjective forms; e.g., Blindness vs. Blind MedDRA/Japanese Currency Flag All Japanese LLTs have assigned a Japanese currency flag of either “Y” (current) or “N” (non-current). Japanese currency flag “Y” (current) is assigned to: MedDRA/J LLTs that have a unique Japanese translation (i.e., no other terms have the same Japanese translation) A single MedDRA/J LLT selected from a group of MedDRA/J LLTs that have the same Japanese translation 1 Japanese currency flag “N” is assigned to: MedDRA/J LLTs corresponding to non-current English terms MedDRA/J LLTs having identical Japanese translations to a term flagged “Y” in Japanese currency flag Priority for Assignment of MedDRA/J Currency Flag “Y” To determine which MedDRA/J LLT receives the “Y” currency flag, terms are considered in the following priority order. (Note that items 1 – 7 below correspond to the list under “Duplicate Japanese Translations” above): (Default) LLTs identical to their PTs 1. British spelling 2. Fully spelled term 3. Singular form 4. Natural word order in English 5. Those terms frequently used in the medical field 6. Case by case 7. Noun form If assignment of the currency flag cannot be determined based on the above priorities, additional consideration is given to the order of Japanese translations listed in The Japan Medical Terminology [Japanese-English version]. 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). MedDRA/J Synonym Lists To address some of the linguistic challenges described above, the JMO distributes a Japanese synonym file with each MedDRA release. The following are the Japanese synonym type descriptions, and the table that follows provides some examples. 1. Synonym: Both Japanese terms are valid medical terms and are translated into the same English term. (See examples 1, 2, and 3). 2. Colloquial vs. literary/scholarly: One is a colloquial expression and the other is literary/scholarly expression. (See examples 4 and 5). 3. Imported words: Some “imported words” are described using the original 2 pronunciation by the Japanese “KANA” characters. But there are corresponding Japanese medical terms. (See examples 6, 7, and 8). 4. Renamed diseases: Occasionally, medical academic societies change specific disease names for scientific or social reasons. When this happens, the former disease name is kept as a Japanese synonym. (See examples are 9 and 10). 5. “KANA-KANJI” issue: Japanese characters consist of Kanji, hira-KANA and kata-KANA. There are multiple combinations, and some combinations are used routinely. Common combinations are treated as Japanese synonyms. (See examples 11 and 12). 6. “IJITAI” issue: Over 3,000 Kanji characters are used in Japanese. Several Kanji characters have multiple font forms and multiple computer codes. These are called “IJITAI”. Several “IJITAI” are incorporated into Japanese synonyms. (See examples 13 and 14). Examples of Japanese synonyms No. syn_code syn_kanji 1 90000218 心悸亢進 2 90000373 頻拍 3 90000445 睾丸炎 4 90000126 吃逆 5 90000034 かゆみ 6 90000017 アクネ 7 90000026 おたふくかぜ 8 90000237 静坐不能 9 90001265 精神分裂病 10 90001344 痴呆 11 99000149 犬咬傷 12 99000374 鬱病 llt_code 10033557 10043071 10031064 10020039 10023084 10000496 10028257 10001540 10039626 10012267 10013589 10012378 llt_kanji 動悸 頻脈 精巣炎 しゃっくり そう痒 ざ瘡 ムンプス アカシジア 統合失調症 認知症 イヌ咬傷 うつ病 13 99002990 膣穿孔 10065818 腟穿孔 14 99002908 鼠径部感染 10050821 鼡径部感染 Llt_name Palpitations Tachycardia Orchitis Hiccups Itching Acne Mumps Akathisia Schizophrenia Dementia Dog bite Depression Vaginal perforation Groin infection Use of Japanese synonyms Japanese synonyms are used to aid in data input. Use of Japanese synonym codes or descriptions for regulatory submission or overseas information transmission is not permitted. For regulatory submission or overseas information transmission, it is required to use the LLT code or description to which the Japanese synonym is linked. The Japanese synonym file can be imported to MedDRA/J Browser. Also, JMO subscribers can use Japanese synonyms in the Web based MedDRA/J browser. 3 Maintenance of Japanese synonyms MedDRA Japanese synonyms are maintained by the JMO, and JMO subscribers can submit change requests for Japanese synonyms using the usual change request procedure. Japanese synonyms are updated with each MedDRA version. The new Japanese synonym file is usually uploaded onto the JMO Web site one month following the new MedDRA version release. At the time of posting, the JMO updates the Japanese synonyms on the JMO Web based Browser. ASCII file information The Japanese synonyms are provided as an ASCII file similar to the MedDRA ASCII files. The file structure and the field descriptions are listed in the following tables. File structure of Japanese synonym file (file name: llt_syn.asc) Field Names Field Attributes llt_code long integer, not null llt_s_kanji char (140), not null llt_s_jcurr char (1), not null llt_s_kana char (200) llt_s_kana1 char (200) llt_s_kana2 char (200) llt_s_code long integer, not null Field descriptions Table Name Field Name llt_code llt_s_kanji llt_s_jcurr llt_s_kana 1_llt_syn llt_s_kana1 llt_s_kana2 llt_s_code Field Attributes 8-digit code to identify the Lowest Level Term Full Kanji name of the J-Synonym Term Indicates whether the J-Synonym Term (“S”) Full Kana name of the J-Synonym Term(single byte kana) Full Kana name of the J-Synonym Term(single byte kana, if another reading exists) Full Kana name of the J-Synonym Term(single byte kana, if another additional reading exists) 8-digit code to identify the J-Synonym (Initial code is “9”) 1. Note: Although there are the fields for kana, actual J-Synonym file does not contain kana data. 4 2. Data are delimited by “$”. There is no “$” at the beginning of the first field and after the last field. 5
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