![]() ![]() ![]() ![]() Advantages of EDC systems are support for multi-user and multicenter clinical trials as well as auditable data. In this regard, most EDC vendors support the CDISC ODM standard to define, communicate and archive clinical trial meta- and patient data. In contrast, Electronic Data Capture (EDC) software enables a reliable, secure and auditable collection of data. Therefore, such systems are not able to comply with regulatory requirements for electronic data capture in clinical trials. Spreadsheet-based solutions suffer from several drawbacks: It is generally not possible to ensure a sufficient right and role management it is not traced who has changed data when and why. Usually, data is transferred into statistic software, such as SAS, R or IBM SPSS Statistics, for analyses afterwards. Data capture for clinical registries or pilot studies is often performed in spreadsheet-based applications like Microsoft Excel or IBM SPSS. ![]()
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