The ESOURCE READINESS ASSESSMENT TOOL (eSRA)

The tool contains questions based on regulations and regulatory agency guidelines for clinical research data sources and should be used to evaluate the suitability of an Investigator Site computerized system to provide data for clinical trials.

Clinical research draws on a combination of data collected during a clinical trial and historical medical information relating to the research subject(s). Many of the data points needed for clinical research are originating in Electronic Health Record Systems, making them "eSource" for clinical research. Even if these data points are not used directly from the site's healthcare system, but are re-entered into a Sponsor's system for a clinical trial, the source of the information (the healthcare system) must still be confirmed as compliant with standards set forth in clinical research regulations and applicable guidance documents.

An eClinical Forum team, comprised of CRAs and Data Managers from different clinical research sponsor organizations and CROs and representatives from sites, has produced the "eSource-Readiness Assessment", otherwise known as "eSRA" for sites to perform a self-assessment of their computerized system's ability to be compliant with clinical research regulations.

The eSRA Questionnaire Version 2021 can be downloaded as part of the eSRA Handbook below.


Stay Current!!

As new regulations are released or updated, the eClinical Forum will evaluate if the eSRA questions should be updated. To be notified of future releases of the eSRA Questionnaire, please send an email to eSRA@eClinicalForum.org. Your email address will not be used for purposes other than to inform you of updates to eSRA.

Do we keep a list of sites that have completed eSRAs?

We have frequently been asked if we can provide a list of which sites have already completed an eSRA. Due to privacy laws in different countries, eClinical Forum does not keep such a list. We supply the eSRA questionnaire, free of charge, to anyone who wants to use it. We encourage sponsors to keep a list for themselves of which sites they have received a completed eSRA from. We encourage sites to store their completed eSRA in a central location (such as their IT department) so that other groups within the same organization / using the same electronic healthcare system, can use the completed eSRA as a basis to complete their own eSRA.

eSRA Resources

JAPANESE TRANSLATION of eSRA Handbook and Webinar

Published on Sunday, March 14, 2021

JAPANESE TRANSLATION of eSRA Handbook and Webinar

eSRA Version 2021

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。

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