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JAPANESE TRANSLATION of eSRA Handbook and Webinar

eSRA Version 2021

JAPANESE TRANSLATION of eSRA Handbook and Webinar

The eClinical Forum is pleased to announce that their eSource-Readiness Assessment (eSRA) Handbook v2021 has been translated to Japanese. While the eSRA questionnaire is still required to be completed in English, the Japanese translation of the eSRA Handbook includes an official Japanese translation of the eSRA questions.  The Handbook in Japanese can be downloaded below.

In addition, we are offering a webinar, in the Japanese language, on the use of eSRA. This was presented in September 2020. 

The link to the webinar recording in Japanese:  https://transcripts.gotomeeting.com/#/s/bed8f2c17e0541399da3d76318c799cc178ef9efd07b9c64b8f3799ca7531637

eSRA questionnaire is updated annually in the first quarter, based on updates to regulatory authority documents.

As always, if you have any questions pertaining to eSRA, please submit to eSRA@eclinicalforum.org

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eClinical Forum は、このたび eSource-Readiness Assessment (eSRA) Handbook v2021 の日本語版を作成致しました。eSRA questionnaire は英語でご回答いただく必要がありますが、eSRA HandbookにはeSRA questionnaireの各設問の正式な日本語訳を載せています。日本語版Handbookは画面下部の <Documents to download>からダウンロードできます。

eSRAの使い方について2020年9月に日本語でWebinarを実施しており、その録画は https://transcripts.gotomeeting.com/#/s/bed8f2c17e0541399da3d76318c799cc178ef9efd07b9c64b8f3799ca7531637 からご覧いただけます。

eSRAは、規制当局の規制・ガイダンスの変更に対応するために毎年第一四半期に改訂されます。

eSRAに関するご質問は、eSRA@eclinicalforum.orgにお寄せください。

Documents to download

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eCF Birds-of-a-Feather Webinar:  EHR-EDC Integration – Implementation Overview and Learnings

eCF Birds-of-a-Feather Webinar:  EHR-EDC Integration – Implementation Overview and Learnings

Implementing EHR-EDC integrations is an emerging area of focus in the pharma industry.  This presentation will share an overview of implementing an EHR-EDC integration on 2 studies and the associated lessons learned.   Following this overview will be a group discussion on such integrations and prospects for broader adoption within our clinical trials. 

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