Medical Informatics, a publication of the Japan Society for Medical Informatics, published an article which used eSRA to assess the requirements of the Japan MHLW's "Guideline on security management for medical...
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 – on our 2 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials) and eSRA...
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...
Version 2021
This is the ONE FILE that you need to perform an eSRA Assessment.
How to assess site's systems for appropriateness of collecting data for regulated clinical research. (Version 2021)