eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire: Japanese Version 2023.2JP1.  Released on 18-Sep-2023. 

NOTE: A newer version of eSRA was released on 31-Jan-24, and the eSRA Team is working on a Japanese translation to that. We anticipate it to be ready by the end of Q1 2024.

This is the Japanese translation of eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire.  

The translation is provided as a reference to assist sites and sponsors/CROs to use the eSRA. Sites are expected to complete the original, English edition of the eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire.

TO DOWNLOAD THE HANDBOOK, CLICK ON THE TITLE IN "DOCUMENTS TO DOWNLOAD" BELOW.  Instructions for completing an eSRA are in section 3, and eSRA is in section 5.

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eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaireの日本語版2023.2JP1が2023年9月18日にリリースされました。

本書はeSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire 2023年版の日本語訳です。

この翻訳は、治験実施施設、治験依頼者/CROがeSRAを利用する際に参考として提供されるものであり、治験実施施設はオリジナルの英語版のeSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaireに記入することが期待されています。

本書をダウンロードするには、下記 "Documents to download"欄の本書タイトル名をクリックしてください。eSRA記入方法については本書第3章を、eSRA質問票については本書第5章をご覧ください。

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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.

The eClinical Forum shall not be liable for any damages incurred due to this translation or actions taken based on the information in this document.

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When you have completed your eSRA ... Please Help! Be a part of the solution -- An easy way for you to participate in the improvement of our e-clinical environment!  We welcome your feedback on the assessment tool. We would also like to use your completed assessment, in an anonymized way, as part of a summary of the ability and needs of site's computerized systems. We are compiling statistics regarding site abilities, to provide information to software vendors and others, regarding areas for improvement. It is our goal that all healthcare systems will become compliant with clinical research regulations and guidances. Please help us -- send your completed assessment to eSRA@eClinicalForum.org   You are welcome to strip off your organization identifying information before sending, however, this is not necessary as we promise to not use this portion of the assessment for our summary purposes. Feedback is always welcome (both positive and critical) -- please send to esra@eclinicalforum.org.