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Japanese Translation: eSRA Handbook and Assessment Forms V2026

Japanese Translation: eSRA Handbook and Assessment Forms V2026

eSRA (e‑Site System Readiness Assessment) Handbook and Assessment Questionnaire: Japanese Version 2026JP1
Released on 02 June 2026
This document is a Japanese translation of the eSRA Handbook and Assessment Questionnaire.
The translation is provided for reference purposes to assist sites and sponsors/CROs in using the eSRA. Please note that sites are expected to complete the original English version of the eSRA Handbook and Assessment Questionnaire.
To download the handbook, click the title under “Documents to Download” below.
Instructions for completing the eSRA are provided in Section 3. The eSRA Form/S and eSRA Form/F are included in Section 7.

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eSRA (e-Site System Readiness Assessment) Handbook and Assessment Questionnaireの日本語版2026JP1が2026年6月2日にリリースされました。
本書はeSRA Handbook and Assessment Questionnaire 2026版の日本語訳です。
この翻訳は、治験実施施設及び治験依頼者/CROが、eSRAを利用するうえで、参考用に提供されるものです。治験実施施設は、この翻訳を参考にして、オリジナルの英語版のeSRA Handbook and Assessment Questionnaireを完成させてください。
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章をご覧ください。eSRA Form/S 及び eSRA Form/Fの翻訳は本書第7章をご覧ください。

Documents to download

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eCF Webinar November: FDA warning letters for audit trail analytics

FDA warning letters tell us what went wrong, but what could your audit trail analytics program have caught earlier? Join our upcoming webinar for a practical, in-depth look at an FDA warning letter and learn how to identify missed signals, uncover blind spots, and strengthen your audit trail review program.

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