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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.
Applied Clinical Trials has published an article highlighting the eClinical Forum “Requirements for Electronic Data for Regulated Clinical Trials” (or simply, “eCF Requirements”: http://www.appliedclinicaltrialsonline.com/keeping-regulatory-expectations . July 8, 2019
The eCF Requirements are based upon statements in regulatory documents (from the FDA, EMA, PMDA and ICH) 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
The eCF EDC Hosting Team has released the final White Paper documenting best practices for establishing controls and operational procedures that facilitate compliance with evolving regulatory expectations for Electronic Data Capture in Clinical Trials using Service Providers (e.g. EMA Reflection Paper and ICH GCP Addendum). The eCF has engaged with regulators (including the EMA GCP IWG and FDA) and industry stakeholders in developing the documents.
Nearly 200 attendees participated in a webinar delivered by the eClinical Forum for ACRP.
The objective of the webinar was to allow attendees to:
Abstract
In 2001, a survey was conducted by the eClinical Forum to explore the experience, needs, views and issues of investigational site staff with respect to Electronic Data Capture (EDC).
Companies engaged in commercial clinical research have, since the introduction of formalized good clinical practices (GCP), adopted highly defensive practices around the monitoring of clinical trials.
CASE STUDY EHR4CR - A new technological platform enabling the re-use of data from electronic health records.
Submission of comments to the FDA on their Draft Guidance on Standardized Study Data
eCF Submission to EMA on their Reflection Paper on the Use of IRT (Interactive Voice/Web response Systems in Clinical Trials)
Practical Considerations for Clinical Trial Sites using Electronic Health Records (EHRs) certified for Clinical Research
eCF comments on FDA Draft Guidance: Electronic Source Doc in Clinical Investigations
The EHRCR Functional Profile Working Group is comprised of dedicated individuals from the United States and the European Union in the following industries: pharmaceutical, biotechnology, clinical research technology vendor, healthcare technology vendor, and federal regulator.
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eCF Views & News
We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.
eCF Technology Showcase: The Impact of AI Driven Automation and Data Transformation - A Guided User Experience for Automated Mapping
eClinical Solutions, and eCF member company will present an approach to AI that aims to bridge that gap – a guided user experience for automated mapping.
The eClinical Forum is happy to showcase their members, however does not promote nor endorse any particular technology solution.
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.
eCF Webinar: Audit Trail Review – Is your Audit Trail fit for purpose?
Date: Thursday, February 20, 2025 Duration: One hour
Presenter: Dr. Torsten Stemmler, head of GCP inspections at the Federal Institute for Drugs and Medical Devices (BfArM)
Dr Torsten Stemmler has been involved in GCP inspections since 2017 and has contributed to various European guidelines (e.g. Guideline on computerised systems and electronic data in clinical trials). He has a background in data management and neurobiology (specialising in psychophysics). He is currently working on GCP inspections and artificial intelligence in the EMA eSubgroup.
eCF Technology Showcase: AiCure: Using AI to improve patient adherence, compliance, and retention
AiCure, and eCF member company will present how their software uses AI to improve patient adherence, compliance, and retention.
eCF Spring 2025 Workshops Announced
We are pleased to announce our 2025 Spring Workshops.
These workshops will be in-person, with the UK workshop also being live-streamed for any eCF member around the globe to join. Each eCF member organisation has a certain number of seats available for in-person participation, depending on the membership type (please contact your eCF Primary representative to discuss using a member seat). Joining the UK workshop via live-stream is gratis for anyone in an eCF member organisation.
April 29-May 1: King-of-Prussia, PA, USA (kindly hosted by CSL Behring)
May 13-15: Walton Oaks, Surrey, UK (kindly hosted by Pfizer)