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Figure 4 | Trials

Figure 4

From: Heterogeneity prevails: the state of clinical trial data management in Europe - results of a survey of ECRIN centres

Figure 4

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).

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Trials

ISSN: 1745-6215