ascopubs.org

Implementing an Electronic Data Capture System to Improve Clinical Workflow in a Large Academic Radiation Oncology Practice

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 ...
JD Supra

Final FDA electronic systems guidance offers greater compliance flexibility

Last week, FDA issued the final version of its 2023 revised draft guidance, “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers,” which ...
RAPS

Revised Draft Guidance Calls for Greater Use of Electronic Data

US regulators have released a new draft guidance document aimed at providing industry with insight on the use of electronic source data in clinical investigations.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 ...
Becker's Hospital Review

FDA wants to conduct EHR to EDC data capture tests

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 ...