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One of the fundamental requirements of 21 CFR Part 11 is controlling user access in clinical trial applications. You do not want to unintentionally give someone access to something he or she should not have. To avoid these situations, Oracle Clinical and Remote Data Capture (RDC) comes with a set of predefined database roles that system administrators can set to enable users to perform specific tasks, yet prevent them from taking actions they are not authorized to take.
While the predefined roles serve as a good starting point, it is critical for organizations to decide which roles make sense for the way they do business. In such cases, it may be beneficial to create new custom roles. While this process is not overly complex, it is easy to overlook several aspects that can make all the difference.
Perficient’s Tammy Dutkin, director of Clinical Data Management and EDC, showed organizations how to take ownership of their own database roles to ensure they remain compliant.