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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.
This webinar recording provides the same content as was presented to the FDA CDER Health IT Board on 6-April-2021 – on our 2 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials) and eSRA (Site eSource-Readiness Assessment).This public webinar was given on 28-April-2021 to over 250 registrants worldwide.
“eCF Requirements” - The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents (FDA, EMA, PMDA, NMPA and ICH) that pertain to the design, development, implementation, and management of electronic systems that support clinical research data. Each Requirement has, as its basis, one or more statements from one or more of these regulatory documents. The eCF Requirements can be used to determine if systems are consistent with regulatory requirements, and if systems and process that manage these data have the necessary features. This set of requirements is the result of countless hours of discussion among regulatory experts from the eClinical Forum member organizations over the past 10 years. It is updated annually.
“eSRA” – The eClinical Forum’s free Investigator Site self-assessment, of the readiness of their healthcare systems to originate data that could be used in a regulated clinical trial, is based on the eCF Requirements and thus each question is grounded on one or more regulatory document statements. It is easy to access and easy to use and has been used by thousands of sites around the globe and many pharmaceutical sponsors and CROs since it’s launch in 2015. It is updated annually. A document, specifically geared to answering Sponsor’s implementation questions, has also been updated and recently released.
New versions of both the “eCF Requirements” and “eSRA” have just been released at www.eclinicalforum.org. Please see the Downloads tab and the eSRA tab.
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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 Birds-of-a-Feather Webinar: EHR-EDC Integration – Implementation Overview and Learnings
Implementing EHR-EDC integrations is an emerging area of focus in the pharma industry. This presentation will share an overview of implementing an EHR-EDC integration on 2 studies and the associated lessons learned. Following this overview will be a group discussion on such integrations and prospects for broader adoption within our clinical trials.
eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023
The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023"
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 source or manage 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.
eCF Spring Workshops Announced
Europe/Global hybrid workshop -- April 16-18
Americas in-person workshop -- April 30 - May 2
eCF Spring Workshop in Zurich, Switzerland
This workshop is hosted by BSI Life Sciences at their office in Zurich, Switzerland on April 16-18. It will also be live-streamed and recorded for access by all eCF members.
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.