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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 eClinical Forum is happy to announce the Public release of the “eCF Requirements V2018PR”. This is a project the eCF REG team has been working on for a long time and is excited to now be sharing.
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.
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:
The eClinical Forum Risk Based Monitoring Taskforce offers some best practices for ensuring clinical data quality. Applied Clinical Trials July/August 2013
Revisiting the eClinical Paradigm
Investigational Site Perspectives on Clinical Trial Information Systems
As the healthcare and pharmaceutical technology spheres move closer together at the clinical research interface, the eClinical paradigm needs to be revisited in order to leverage emerging political, cultural, procedural and technological opportunities. Understanding investigational site experiences with today’s clinical trial technologies and their perspectives on future requirements is critical to delivery of improved eClinical solutions.
2010: Practical Considerations for Clinical Trial Sites using EHRs In support of Clinical Research, Release 1.0 January 18, 2010
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).
Improved access to patient data is key to managing bottlenecks in clinical research. The presentation gives an overview of one of the largest public-private partnerships aimed at providing adaptable, reusable and scalable solutions for re-using patient level data from Electronic Health Record systems for Clinical Research.
Investigators are frequently asked to complete sponsor-specific assessments of their EHR systems to enable sponsors to evaluate clinical trial data that will be sourced from these systems.
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.
The eClinical Forum eSource Sub-team is working on a common assessment tool to determine Investigator Site eSource-Readiness.
CASE STUDY EHR4CR - A new technological platform enabling the re-use of data from electronic health records.
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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.
New eCF ISF System Assessment!
eClinical Forum now has 2 FREE assessment forms for sites to self-assess their systems for use in regulated clinical trials. We are excited to release the first version of the “ISF System Assessment”. This assessment form is very similar to our eSource-Readiness Assessment (eSRA) and is, like eSRA, based on regulatory documents from regulators around the globe.
(16/04/2024 - 18/04/2024)
eCF Spring Workshop in Ridgefield, Connecticut USA
Registration is open for the eCF Spring Workshop, kindly hosted by Boehringer Ingelheim at their Ridgefield, Connecticut campus on April 30 to May 3, 2024.