A Web-based point-and-click EDC known as Brocade was internally developed and implemented systemwide in 2016. Brocade captures key data elements, such as stage, histology, and patient and treatment ...
The U.S. Food and Drug Administration is seeking to conduct demonstration projects testing the capability and performance of a single-point data capture approach between EHRs and electronic data ...
US regulators have released a new draft guidance document aimed at providing industry with insight on the use of electronic source data in clinical investigations. The guidance, set to be published on ...