Figure 1
From: Standard requirements for GCP-compliant data management in multinational clinical trials
Standards and guidelines related to GCP. International and European regulations and guidelines that are relevant for GCP-compliant computer systems and data management are displayed as small boxes. Arrows connecting these documents indicate important references from one document to another (e.g. the arrow from EU-Dir 2005/28 to EU-Dir 95/46 means that EU-Dir 2005/28 refers to EU-Dir 95/46). The correspondence of ICH E6 GCP and European CPMP ICH/135/95 is indicated by a bold arrow.