Figure 4From: Heterogeneity prevails: the state of clinical trial data management in Europe - results of a survey of ECRIN centres Quality management of data management. Availability of CDMS which comply with guidelines and legal requirements: left: DM which is compliant with GCP, GAMP and FDA requirements (internal system validation) and right: DM which has undergone independent validation (external audit). SV: system validation, GAMP: Good Automated Manufacturing Practice, FDA: Food and Drug Administration (here: 21 CFR Part 11), (shown are % centres performing DM).Back to article page