What strikes me is how often the radical reform is simply allowing something that was never actually prohibited. Decentralised visits, remote source data verification and central statistical monitoring were all defensible under ICH GCP long before anyone dared use them; sponsors just had no precedent to point at during an inspection. The blocker is risk appetite inside quality and clinical operations, not the regulation. It also creates a skills gap, because a monitor who has only done 100 percent SDV is not automatically able to run a risk-based approach. Short explainer on how GCP and GDP requirements actually translate into day-to-day work: https://www.sire-search.com/gcp-en-gdp-in-de-life-sciences-wat-deze-compliance-termen-betekenen/
What strikes me is how often the radical reform is simply allowing something that was never actually prohibited. Decentralised visits, remote source data verification and central statistical monitoring were all defensible under ICH GCP long before anyone dared use them; sponsors just had no precedent to point at during an inspection. The blocker is risk appetite inside quality and clinical operations, not the regulation. It also creates a skills gap, because a monitor who has only done 100 percent SDV is not automatically able to run a risk-based approach. Short explainer on how GCP and GDP requirements actually translate into day-to-day work: https://www.sire-search.com/gcp-en-gdp-in-de-life-sciences-wat-deze-compliance-termen-betekenen/