"This is the best use of my time to remain current with what is going on in the industry."
WHO WE ARE
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 2022.1JP1. Released on 10-May-2022.
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 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.
eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaireの日本語版2022.1JP1が2022年5月10日にリリースされました。
本書はeSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire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 email@example.com.
NOT A MEMBER?
eCF BoF Webinar: Principal Investigator's Signature: Best Practices
The eCF’s PI Signature Working Group have updated their 3-year-old document which is released to eCF Members in early April. They will introduce the 2022 changes to the best practice document for Investigator’s signature on electronic Case Report Forms (eCRFs). Participants are encouraged to share their thoughts on:
- how to provide continuous monitoring of regulatory expectations;
- sharing members’ experience on implementation and regulatory findings (if any);
- brainstorming for an industry definition of the “meaning” of signature on data reported to sponsors during both traditional and non-traditional clinical trials.
Presenters: eCF PI Signature Team Leaders: Cinzia Piccinia (Eli Lilly) and Babette von Hagen (CSL Behring)
Japanese translation of eSRA V2022
Version 2022.1JP1 (10-May-2022)
Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)
REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022
We are pleased to announce that registration is now open for our next European Workshop at the Crowne Plaza Brussels Airport, Brussels on 17-19 May 2022.
This hybrid workshop is available for face-to-face or remote participation.
REGISTRATION OPEN: eClinical Forum Hybrid Workshop, New Jersey June 8-10 2022
We are pleased to announce that registration is open for our hybrid workshop at the Old York Cellars in Ringoes, NJ on June 8-10 2022. We are very excited that we can offer this safe and fun venue as we will be meeting in an open-air event tent amidst their beautiful vineyard. Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange, contribution to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A as well as evening networking events. For those who cannot join in person, some of the sessions will be live-streamed and recorded.