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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.
Congratulations to the joint C-Path/eCF :eCOA Best Practices" Team for publishing their paper “Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes”
in the peer-reviewed SCDM Journal “Digital First”.
Version 2023.2JP1 (18-Sep-2023)
Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)
The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2022"
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.
The eClinical Forum is happy to announce the release of the "Investigator’s signature on electronic Case Report Forms (eCRFs), PR2.1"
About the Best Practice Document: There is increased scrutiny by regulatory agencies on the collection of investigator’s signatures as evidence of the overall oversight on the eCRF is reported to the sponsor. eClinical Forum PI Signature Working Group was formed in March 2021 to update the best practice document originally issued in 2017 by identifying best practices that are based on compliance to regulatory requirements and on risks such as reputation, credibility, legal liability of the data being used by the sponsor.
The eClinical Forum is happy to announce the release of the "Investigator’s signature on electronic Case Report Forms (eCRFs), MR2022”.
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.
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
This is the 2021JP1 version.
Voluntary Investigator Site Survey survey concluded with 528 responses.
Representatives from the eClinical Forum participated in the meeting with inspectors and observers in London 12th June to discuss challenges and trends in Clinical Research. We presented the work of the eClinical Forum in the areas of contractual requirements and risk-based software validation… Expand article to read more...
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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 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 Workshops Announced
Europe/Global hybrid workshop -- April 16-18
Americas in-person workshop -- April 30 - May 2
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.