ascopubs.org

Implementing an Electronic Data Capture System to Improve Clinical Workflow in a Large ...

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 ...
ascopubs.org

Development of an Electronic Health Record Registry to Facilitate Collection of Commission ...

Pertuzumab Plus Trastuzumab for Treatment-Refractory HER2-Amplified Metastatic Colorectal Cancer: Comparison of the MyPathway Trial With a Real-World External Control Arm The smart functionality of ...
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Last week, FDA issued the final version of its 2023 revised draft guidance, “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers,” which ...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Revised Draft Guidance Calls for Greater Use of Electronic Data

US regulators have released a new draft guidance document aimed at providing industry with insight on the use of electronic source data in clinical investigations.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

FDA Finalizes Widely Anticipated Guidance on Use of Electronic Source Data in Clinical ...

US Food and Drug Administration (FDA) officials have finalized a November 2012 draft guidance on the use of electronic source data in clinical investigations, calling for its greater use to promote ...