Good Clinical Practice GCP Just Had It's Biggest Change In Over a Decade

The 2016 publication of ICH E6 (R2) Section 5.0 states that sponsors must implement a quality management system to manage quality throughout the design, conduct, recording, evaluation, reporting and archiving of clinical trials. This system should focus on trial activities that are essential to ensuring human subjects protection and the reliability of trial results.

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Has your organization updated your SOP's to meet compliance requirements with these new regulatory changes? 

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