eSRA (eSource Readiness Assessment) is a tool to assess the data that has originated in an Investigator Site system (Electronic Health Records (EHR) or Electronic Medical Records (EMR) according to different health authorities. eClinical Forum issued a Japanese translation of eSRA Handbook in July.  This seminar is targeted for Japanese audiences, and eSRA will be explained in Japanese.
eSRA (eSource Readiness Assessment)はEHR/EMRなどの医療機関のシステムのデータを治験に利用できるかどうか評価するためのツールであり、7月にeSRA Handbookの日本語版がリリースされました。本Webinarは日本の方を対象にeSRAをご紹介するものです。ぜひご参加をお待ちしています。

The eClinical Forum is pleased to announce that their eSource-Readiness Assessment (eSRA) Handbook has been translated to Japanese. While the eSRA questionnaire V2020 has not changed and is still required to be completed in English, the Japanese translation of the eSRA Handbook now also includes an official Japanese translation of the eSRA questions.  A public webinar was provided in Japanese in September 2020 and the recording is available for review.

eClinical Forum は、このたび eSource-Readiness Assessment (eSRA) Handbookの日本語版を作成致しました。eSRA questionnaire V2020は変更されておらず、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。

eSRA Handbookのダウンロードは、上のタイトル行をクリックして表示されるダウンロードページから行ってください。

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Presenter:  Kelley Olree, Study Manager – Pfizer, and eClinical Forum eSRA Team

This webinar will discuss:

• What the Sponsor’s responsibility is regarding using data that has originated in an Investigator Site system (Electronic Health Records (EHR) or Electronic Medical Records (EMR) according to different health authorities
• Benefits of all sites and all sponsors and all CROs using a common assessment tool
• The eClinical Forum, a non-profit, non-commercial discussion/action group comprised of members of the Pharmaceutical and Clinical Research Services industry, along with sites and academia, have developed a regulatory-based assessment tool for clinical research sites to determine if their computer system (EHR, EMR, etc) is appropriate to hold regulated clinical trial data. It has been available for free for over 4 years and is currently being used around the globe by many sponsors and thousands of sites.
• The eClinical Forum’s free “eSource-Readiness Assessment” (eSRA) that assists the sponsor/site in determining if the site system is appropriate for sourcing clinical research records
• How a Sponsor/CRO can incorporate eSRA into their processes

This document is written specifically for Sponsors to assist them in determining how to fit eCF's eSource-Readiness Assessment (eSRA) into their procedures for determining if data which originated on a  site's electronic health record system is suitable for use in their clinical trial. It shows the benefits of using a common assessment tool, provides suggestions for implementing eSRA, and shows a mapping of eSRA questions to regulatory authority statements/expectations.

On 25-Feb-2020, Kelley Olree of Pfizer and eClinical Forum's eSRA Team, presented a very informative and insightful webinar on “Sponsor responsibility to Assess Investigator Site Systems that may originate source for clinical trials & the free eSRA tool”. One participant sent us a note following the webinar "Let me congratulate you for the eSRA Form and the webcast shared yesterday. I’m pretty sure it will become an international standard."