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The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.
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。
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.
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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Japanese translation of Inv Site File Assessment
Version 2024JP1 (25-Nov-2024)
Japanese translation of ISF Assessment Handbook and Assessment Questionnaire (ISFA日本語訳)
eCF Birds-of-a-Feather Round-Table: “Navigating the Exciting and Confusing Landscape of AI Solutions for Document Automation”
This is an eCF Birds-of-a-Feather Round-table discussion on the new landscape of AI use in clinical research document automation. All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis.
Webinar: eClinical Forum Membership Overview
The eClinical Forum is “For the members and by the members” and we want to be sure that we are providing our members with the best possible support for what they do. This webinar is targetted to our "primary representatives" from each eCF member organization, however anyone interested in understanding an overview of the eClinical Forum is welcome to attend. eClinical Forum membership is per company (not individual) and participation in eCF online events, project teams, and members-only publications are available to each person in a member organization without any additional cost.
eCF “Think GCP” Webinar: ICH E6(R3) for eCF Members
Presenter: Rebecca Stanbrook, GCP Strategic Lead, Process & Risk Surveillance, Novartis, EFPIA Topic Lead ICH E6(R3)
About this topic: The final piece of the GCP renovation puzzle, revision 3 of ICH GCP. Understand the background to the renovation, key changes and the philosophy of the changes in this one hour webinar.