A Beginner's Guide To Compliant Electronic Source Data Capture

By William Sharp, Manager, Marketing

Are you using electronic source data capture?

According to ICH GCP 5.18 guidance, the purpose of trial monitoring is to verify each participant’s wellbeing is protected, data is accurate, and the trial is conducted in compliance with any regulatory requirements. Additionally, the Food & Drug Administration’s (FDA) Guidance for Industry establishes expectations for electronic source data capture, review, and retention. This guidance aims to help ensure source data’s reliability, quality, integrity, and traceability from electronic source to submission.

With today’s complex trials, the expectation of gathering faster results in an increasingly decentralized environment is only increasing, imploring investigators to implement electronic source data capture systems. How can researchers ensure this is done correctly? Leveraging the right technology to standardize a compliant process for source data capture is a proven way to reach these goals.