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...
The regulatory overview presented in this paper shows that while regulations are far from final for all use cases, the US and Europe have made the biggest steps toward monitoring and facilitating the use of AI, and regulations are in development in...
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...
The Society for Clinical Data Management (SCDM) and eClinical Forum (eCF) Joint Task Force are pleased to announce the publication of an industry position paper “AUDIT TRAIL REVIEW: A KEY TOOL TO ENSURE DATA INTEGRITY” final version based...
Voluntary Investigator Site Survey survey concluded with 528 responses.
We had a fabulous level of participation with well over 50 members online from California to Japan participating in our Technology Showcase exploring electronic informed consent and demonstrating Enforme Interactive/Drug Dev’s SecureConsent...