Jennifer Yee, Clinical Data Manager III, PROMETRIKA, LLC
The Data Standards Series: Part 1
The top priority of a Clinical Research Organization (CRO) is to help a sponsor conduct a successful clinical trial. That success is measured in data quality, process efficiency, and cost effectiveness. In order to achieve these goals, many organizations find they benefit from the development of a global library. A global library (GL) is a digital repository in a Clinical Data Management System (CDMS) that contains data collection instruments, such as electronic case report forms (eCRF) and their associated programming elements.
During database build, the library functionality allows for the copying of pre-validated objects, such as variables, code lists and edit checks, from the GL into new projects. Confidence in the pre-validation of the GL allows these objects to be copied without reprogramming or testing. By eliminating these time-consuming tasks, CROs can develop projects with design consistency, significant time savings, and reduced cost; features critical to the success of a study.