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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.
The clinical trial industry is undergoing a rapid transition toward decentralization, where some or all health assessments are performed remotely in participants’ homes instead of in medical centers. Adopting artificial intelligence in this setting can empower more patients to enroll in trials, successfully complete them without burden, and submit high-fidelity assessments of their health. In this talk, the presenters will discuss insights from their recent article in Nature Medicine on this topic. The article can be viewed at: Artificial intelligence can improve patients’ experience in decentralized clinical trials | Nature Medicine
The eClinical Forum is happy to announce the release of the "Investigator’s signature on electronic Case Report Forms (eCRFs), PR2.1"
About the Best Practice Document: There is increased scrutiny by regulatory agencies on the collection of investigator’s signatures as evidence of the overall oversight on the eCRF is reported to the sponsor. eClinical Forum PI Signature Working Group was formed in March 2021 to update the best practice document originally issued in 2017 by identifying best practices that are based on compliance to regulatory requirements and on risks such as reputation, credibility, legal liability of the data being used by the sponsor.
“Birds-of-a-Feather” Webinars are provided monthly, to get those with similar interests together. Anyone from an eCF member company (around the globe!) can participate, gratis. All eCF members can suggest a topic and/or lead a discussion.
We send a monthly email newsletter to our members to keep them abreast of eCF Views (items on our online members-only discussion board) and eCF News (upcoming events, activities of our project teams, etc). If you would like to be included in the monthly e-newsletter mailing, please send a note to Webmaster3@eclinicalforum.org. Click "Read More" to see this month's "Views & News"!
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.
Version 2022.1JP1 (10-May-2022)
Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)
The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2021"
ABOUT THE ECF REQUIREMENTS: The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial. We have reviewed regulatory documents from the FDA, EMA, PMDA, NMPA, MHRA and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if systems that data which will become part of a regulated clinical trial are consistent with regulatory requirements and if systems and process that manage these data have the necessary features.
Version 2022.2 (25-May-2022; only the license agreement for those re-using in another form has been updated)
This is the ONE FILE that you need to perform an eSRA Assessment.
How to assess site's systems for appropriateness of collecting data for regulated clinical research. (Version 2022)
Medical Informatics (Japan Society for Medical Informatics) article on use of eSRA to assess the requirements of the Japan MHLW's "Guideline on security management for medical information systems."
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eCF Webinar: Assessing e-Investigator Site Files for compliance with regulatory expectations (eCF eISFQ)
The intention of this webinar is to introduce you to the newest eCF Site Assessment -- the draft eInvestigator Site File Questionnaire (eISFQ). Each question in the eISFQ is based on regulatory authority document statements. It is intended for sites to self-assess their eISF such that sponsors can determine if it is suitable to use for their regulated clinical trials. The eCF eISFQ Team intends to start a pilot with the the eISFQ in late 1Q '23. We would like to present this information to our members to get your feedback and to inspire interest in participating in the pilot.
eCF Webinar: Artificial intelligence can improve patients’ experience in decentralized clinical trials