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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.
“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)
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."
Several members of the eClinical Forum's Regulatory Advisory Group have published an article in Applied Clinical Trials on "When should audit trail begin?" It is a discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.
We welcome feedback! Please send to: REG@eclinicalforum.org
This webinar recording provides the same content as was presented to the FDA CDER Health IT Board on 6-April-2021
The Society for Clinical Data Management (SCDM) and eClinical Forum (eCF) Joint Task Force are pleased to announce the publication of an industry position paper “AUDIT TRAIL REVIEW: A KEY TOOL TO ENSURE DATA INTEGRITY” final version based on Industry Feedback. With various electronic data capture modalities becoming the norm and the growing regulatory focus on data collection traceability, audit trails which capture the who, what, when, and why of electronic data entry and amendments are a critical tool. This paper outlines an industry perspective on maximizing the value of implementing the targeted, routine review of these extremely large datasets. It provides recommendations on risk-based use cases for audit trail review (ATR) and the corresponding desired reporting criteria, with suggestions on when to use visualizations and exception report listings to generate key, actionable insights.
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eCF Webinar: Artificial intelligence can improve patients’ experience in decentralized clinical trials
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
eCF Technology Showcase: BSI Life Sciences - "Onboarding a combined CTMS and eTMF”
The digitalization of clinical trials and operations has been at the forefront of pharmaceutical and med-tech modernization strategies over the last two decades. However, many companies are still struggling to digitize their clinical operations for various reasons: old habits, fear of adopting and rolling out an electronic solution, potential delays on deadlines, or concerns about quality and compliance. eCF Member BSI will share their thoughts on why a unified CTMS and eTMF is crucial in running clinical trials in the age of digitization and technology, while providing examples with their CTMS and eTMF.
eClinical Forum In-Person and Remote Workshop, Blue Bell, PA
We are pleased to announce our next Americas Workshop in Blue Bell, PA USA on May 15-17 kindly hosted by Signant Health.
This workshop will be available for face-to-face and remote participation.
We hope you can join us!
REGISTRATION IS OPEN: eClinical Forum Hybrid Workshop, Darmstadt, Germany June 14-16, 2023
We are pleased to announce that registration is now open for our next European Workshop in Darmstadt Germany on June 14-16 hosted by eClinical Forum.
This hybrid workshop is available for face-to-face or remote participation.
READ MORE to download Agenda