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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The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2019PR”.

ABOUT THE ECF REQUIREMENTSThe eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial.  We have reviewed regulatory documents from the FDA, EMA, PMDA, and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if systems that data which will become part of a regulated clinical trial are consistent with regulatory requirements and if systems and process that manage these data have the necessary features.

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

Applied Clinical Trials has published an article highlighting the eClinical Forum “Requirements for Electronic Data for Regulated Clinical Trials” (or simply, “eCF Requirements”: http://www.appliedclinicaltrialsonline.com/keeping-regulatory-expectations .  July 8, 2019

The eCF Requirements are based upon statements in regulatory documents (from the FDA, EMA, PMDA and ICH) that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial