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,...
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...
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 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...
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...
This webinar recording provides the same content as was presented to the FDA CDER Health IT Board on 6-April-2021. Even in 2024, the content is still relevant.