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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.
eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire: Japanese Version 2024JP1. Released on 20-May-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2024JP1が2024年5月20日にリリースされました。
本書はeSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire 2024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。
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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Requirements for Electronic Data for Regulated Clinical Trials - "eCF Requirements" past public releases 2018 - 2023
The eCF REG team puts out a yearly version of the "eCF Requirements" which many orgainizations use to check compliance of their systems against regulatory authority document statements. The previous versions have been requested in order to easily check the requirements that were in place in a particular year.
eCF APAC Autumn Workshop 2024 Announced
Registration is open! Our APAC Autumn workshop will be kindly hosted by Clario at the Hyatt Regency Tokyo Bayin Urayasu, Japan on November 11-12 2024.
eCF Birds-of-a-Feather Round-Table: Risk-Based Source Data Verification
This topic is coming out of a discussion that started at the eCF Workshop in Massachusetts in October. The group decided they wanted more time to delve more deeply into this discussion and to include eCF members from other regions. The discussion will be around:
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.