Eudralex

What SOPs do sponsors need to demonstrate GCP compliance?

The need for SOPs in ICH-GCP (5.1.1) is clear: “The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s)”. Mentions of SOPs are … Continue reading →