June 16, 2021
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.
January 01, 2019
An increase in use of EHR systems at clinical investigative sites adds more expectations for clinical trial sponsors to comply by regulatory requirements.
December 13, 2018
Electronic Health Record (EHR) systems are being used increasingly by clinical investigative sites.