#meddra

Dictionary coding is a regulatory necessity for many trials and an advantage for many more. The clear market leader in this area with the broadest recognition is MedDRA (Medical Dictionary for Regulatory Activities). CRFweb has MedDRA coding integrated into our application and offers the following key functionality:

In-built MedDRA dictionary

Dictionary version available to match your license

Auto and manual mapping of MedDRA codes

Easy to use eCRF browser to search code at all levels

Export the coded study to PDF

CRFweb now features a fully integrated ePRO (electronic patient reported outcome) interface, where subjects can answer questionnaires without risk of accessing other functionality or data. Site staff can easily initiate a subject session to allow the subject to answer at the clinic (e.g. using a tablet), or the subject can log in from home with a unique username and password.

A study can be designed to be entirely ePRO. It’s also possible for a particular visit within a study to be designed as ePRO, giving ultimate flexibility in study design. With data entry by the subject, both ePRO and the complimentary eDiary module, lend themselves especially well to post-market studies.

Dictionary coding is a regulatory necessity for many trials and an advantage for many more. The clear market leader in this area with the broadest recognition is MedDRA (Medical Dictionary for Regulatory Activities). CRFweb has MedDRA coding integrated into our application and offers the following key functionality:

In-built MedDRA dictionary Dictionary version available to match your license Auto and manual mapping of MedDRA codes Easy to use eCRF browser to search code at all levels Export the coded study to PDF This is complementary with CRFweb. You will need your own MedDRA license, we will validate this for you, and you are then free to use it as part of your study as long as you maintain your Licence.

錯感覚 さくかんかく paraesthesia 

そう痒症 そうようしょう pruritus

肺線維症 はいせんいしょう pulmonary fibrosis

口内炎 こうないえん stomatitis

血小板減少症 けっしょうばんげんしょうしょう thrombocytopenia

蕁麻疹 じんましん urticaria

白血球減少症 はっけっきゅうげんしょうしょう leukopenia

肝機能検査異常 かんきのうけんさいじょうliver function test abnormal

粘膜障害 ねんまくしょうがい mucous membrane disorder

末梢性ニューロパチー まっしょうせいニューロパチー neuropathy, peripheral

好中球減少症 こうちゅうきゅうげんしょうしょう neutropenia

注射部位壊死 ちゅうしゃぶいえし injection site necrosis

注射部位漏出 ちゅうしゃぶいろうしゅつ injection site extravasation

注射部位紅斑 ちゅうしゃぶいこうはん injection site erythema

注射部位発赤 ちゅうしゃぶいほっせき injection site redness

脱水 だっすい dehydration

不快感 ふかいかん discomfort

味覚異常 みかくいじょう dysgeusia

紅斑 こうはん erythema

発熱性好中球減少症 はつねつせいこうちゅうきゅうげんしょうしょう febrile neutropenia

溶血性尿毒症症候群 ようけつせいにょうどくしょうしょうこうぐん haemolytic uraemic syndrome

過敏症 かびんしょう hypersensitivity