FREE TO DOWNLOAD

The eClinical Forum Download area contains publically available surveys, presentations, articles and reports that can inform your decision making, challenge your thinking, and identify new technological and regulatory trends related to eClinical trials.

A much more extensive archive of information is available to members

TELL ME MORE ABOUT MEMBERSHIP...

 

Downloads

Disclaimer:The information presented in these works draws upon the combined understanding and knowledge of the eClinical Forum and is provided as an aid to understanding the environment for electronic clinical research. The opinions of the author(s) and the eClinical Forum do not necessarily reflect the position of individual companies.The content is unconfirmed and users should assess the content and opinions in the light of their own knowledge, needs and experience as well as interpretation of relevant guidance and regulations.

Creative Commons License These works are licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License

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

-------------------------------------------------------------------------

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

Print

Categories: Regulatory, Electronic Data Capture, eSRANumber of views: 3748

Tags: