"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.
The eClinical Forum is pleased to offer a free public webinar – to provide information on our 3 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials), eSRA (Site eSource-Readiness Assessment), and ISF (Investigator Site File System) Assessment. 18-Sept-24: Registration Required.
What if site users could launch the eCRF with a single click from the patient’s chart, and automatically populate CRFs with data from the chart? This is a Technology Showcase hosted by our newest eCF member, OpenClinica.
As there are no regulatory detailed expectations on oversight by investigators on eCOA data, multiple approaches have been adopted across the industry (from log-in as evidence to notification/alerts or investigator signature on eCOA data). In general, as per other data sources, oversight for eCOA data should be continual and not once at the end of the study. In addition, oversight activities should be right-sized according to the criticality of the data and protocol requirements for compliance. Evidence of the oversight should be available during the conduct of the trial and enduring for the entire retention period. The aim of this webinar is to allow participants to share different approaches and any knowledge of current expectations by regulatory inspectors.
Selected events are recorded and are available un-edited for member use only within the "BoF & TS Recordings" folder below. Not all events will be recorded or released. Recordings are un-edited and are provided for eCF member use only. Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services, and by necessity are not technology or vendor neutral. The eClinical Forum does not promote nor endorse any particular technology vendors.
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eCF Birds-of-a-Feather Webinar: Site experience in the day-and-age of hybrid e-trials
Back by popular demand! Dr. van de Walle presented at the hybrid European eCF workshop in May … and we just ran out of time to answer all the questions! So many requests to ask Viviënne to present again with more time. So, here it is! Not to be missed! Viviënne is a full-time investigator and founder of an indepenent research site. She has vast site and patient experience and will share her insight into how hybrid trials are going for the sites and the patients.
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.
2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)
The "eCF Requirements" Members Release V2024 has been released. This is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over many years to be able to produce such a comprehensive list of compliance requirements for electronic systems that will manage data used in regulated clinical research, against regulations and guidances from 40 different documents from FDA, EMA, PMDA, NMPA, MHRA and ICH and ISO.
Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)
The eClinical Forum is releasing its 7th public version of the “eCF Requirements” which takes all of the requirements and guidance directions that pertain to electronic data and electronic systems that support clinical research, from FDA, EMA, PMDA, MNPA, MHRA and ICH , and boils them down into 37 unique statements or "eCF Requirements".
eCF Birds-of-a-Feather Webinar: Protocol Optimization using AI/ML
We will be discussing the transformative potential of Artificial Intelligence (AI) and Generative AI in clinical development.
eCF Technology Showcase Webinar: OpenClinca “Unlocking Clinical Data from EHRs”
eCF Free Public Webinar: Regulatory Requirements for Electronic Data/Systems for Clinical Trials, and associated site system assessments
eCF Americas Autumn Workshop 2024 Announced
Registration is open! Our Americas Autumn workshop will be kindly hosted by eClinical Solutions at their offices in Mansfield, Massachussetts (near Boston/Patriots Stadium) on October 22-24 2024.