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Japanese translation of Inv Site File Assessment
Kenichi Nakano
/ Categories: TOPICS, Regulatory, Healthcare, TEAMS, eSRA, eInvestigator Site File Questionaire (eISFQ), PRIVACY, Visible by Public

Japanese translation of Inv Site File Assessment

Investigator Site File System Assessment V2024 Handbook and Questionnaire: Japanese Version 2024JP1.  Released on 25-Nov-2024. 

This is the Japanese translation of the Investigator Site File System Assessment V2024 Handbook and Questionnaire.  

TO DOWNLOAD THE HANDBOOK, CLICK ON THE TITLE IN "DOCUMENTS TO DOWNLOAD" BELOW. 

Instructions for completing an ISF Assessment are in section 3 of this document, and the translation of the ISF Assessment Form is in section 5. The translation is provided as a reference to assist sites and sponsors/CROs in using the ISF Assessment. Sites are expected to complete the original, English edition of the Investigator Site File System Assessment V2024 Handbook and Questionnaire.

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Investigator Site File System Assessment V2024 Handbook and Questionnaire の日本語版2024JP1が2024年11月25日にリリースされました。

本書はInvestigator Site File System Assessment V2024 Handbook and Questionnaire  2024年版の日本語訳です。

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。

Investigator Site File System Assessment 記入方法については本書第3章を、Investigator Site File System Assessment質問票の翻訳については本書第5章をご覧ください。この翻訳は、治験実施施設、治験依頼者/CROがInvestigator Site File System Assessment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Investigator Site File System Assessment V2024 Handbook and Questionnaireに記入することが期待されています。

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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.

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

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. 

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