The eCF REG team puts out a yearly version of the "eCF Requirements" which many orgainizations use to check compliance of their systems against regulatory authority document statements. The previous versions have been requested in order to...
Recording available from our public webinar which provided information on our 3 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials), eSRA (Site eSource-Readiness Assessment), and ISF...
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,...
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,...
The Archiving and Decommission Team is pleased to announce the public release of three white papers:
"The Decommissioning of Computerised Systems Used in Clinical Trials"
"Nature of a Distributed Trial Master File ‐...
The Regulatory Expert Group is happy to announce the release of the English translation of the JPMA EDC Management Sheet v2.00. EDC Management Sheet is a tool by which Japan Pharmaceuticals and Medical Devices Agency (PMDA)...