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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.
Event date: 28/04/2021 Export event
April 28, 2021
eCF Free Public Webinar: Requirements for Electronic Data for Regulated Clinical Trials, and associated Investigator Site eSource-Readiness Assessment
The eClinical Forum is pleased to offer a free public webinar – the same as was presented to the FDA CDER Health IT Board on 6-April-2021 – to provide information on our 2 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials) and eSRA (Site eSource-Readiness Assessment).
“eCF Requirements” - The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents (FDA, EMA, PMDA, NMPA and ICH) that pertain to the design, development, implementation, and management of electronic systems that support clinical research data. Each Requirement has, as its basis, one or more statements from one or more of these regulatory documents. The eCF Requirements can be used to determine if systems are consistent with regulatory requirements, and if systems and process that manage these data have the necessary features. This set of requirements is the result of countless hours of discussion among regulatory experts from the eClinical Forum member organizations over the past 10 years. It is updated annually.
“eSRA” – The eClinical Forum’s free Investigator Site self-assessment, of the readiness of their healthcare systems to originate data that could be used in a regulated clinical trial, is based on the eCF Requirements and thus each question is grounded on one or more regulatory document statements. It is easy to access and easy to use and has been used by thousands of sites around the globe and many pharmaceutical sponsors and CROs since it’s launch in 2015. It is updated annually. A document, specifically geared to answering Sponsor’s implementation questions, has also been updated and recently released.
New versions of both the “eCF Requirements” and “eSRA” have just been released at www.eclinicalforum.org. Please see the Downloads tab and the eSRA tab.
The eClinical Forum is a non-commercial, non-profit global organization with over 40 organizations active in clinical research. For information on all eClinical Forum activities and projects, please see our website: www.eclinicalforum.org
Date/Time: This Webinar is offered at 2 times in order to accommodate participants from around the world. It will also be recorded, so if you cannot attend, please register and we will send you the recording link after the webinar.
Duration: One hour
Webinar A: (Europe/APAC facing) at UTC 07:00 (London 08:00; Brussels 09:00, Mumbai 12:30, Tokyo 16:00)
Webinar B: (Americas/Europe facing) at UTC 16:00 (California 9am, Chicago 11am, NYC Noon, Brazil 1pm, London 5pm, Brussels 6pm)
Alan Yeomans, Viedoc Technologies, eClinical Forum REG team
Ryan Bowe, Signant Health, eClinical Forum REG team
Martijn Griep, Janssen Pharmaceuticals, eClinical Forum eSRA team
To register for this free webinar, please follow this link: Webinar Registration (eclinicalforum.org)
PLEASE NOTE: WE WILL USE YOUR EMAIL ADDRESS FOR SUPPLYING INFORMATION FOR THIS WEBINAR AND NOT FOR ANY ADVERTISING
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Public Release: English Translation of V2.00 of Japan EDC Management Sheet
The Regulatory Expert Group is happy to announce the release of the English translation of the JPMA EDC Management Sheet v2.00. EDC Management Sheet is a tool by which Japan Pharmaceuticals and Medical Devices Agency (PMDA) ensures the computerized system used in clinical trials comply with relevant regulations and guidelines.This is an unofficial translation and made public for anyone to use. Please be advised that the original Japanese version should be used for any disputes.