إنجاز دولي جديد: الغذاء والدواء السعودية تنضم للجنة التوجيهية لقاموس MedDRA التنظيمي http://dlvr.it/TLNVJb

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إنجاز دولي جديد: الغذاء والدواء السعودية تنضم للجنة التوجيهية لقاموس MedDRA التنظيمي http://dlvr.it/TLNVJb
Integrated MedDRA | Medical Dictionary for Regulatory Activities | CRFweb
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.
Fully integrated electronic Patient Reported Outcome ePRO module | CRFweb
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.
In addition to the obvious time and cost saving benefits, there is also the benefit of increased patient engagement in the whole trial process.
Integrated MedDRA | Medical Dictionary for Regulatory Activities | CRFweb
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.
MedDRA
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
視力障害 しりょくしょうがい visual impairment
MedDRA
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
聴器毒性 ちょうきどくせい ototoxicity
MedDRA
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
間質性肺疾患 かんしつせいはいしっかん interstitial lung disease
MedDRA
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
聴力低下 ちょうりょくていか hypoacusis