The participants learn to understand the concepts behind software validation and electronic records, and how they apply to clinical studies. Furthermore, they will acquire specific approaches for the quality assurance of programs for the data management and for analyses and for the validation of reusable SAS macros.
This course provides skills and knowledge for the installation, configuration and application of the SAS Clinical Standards Toolkit. Participants shall be placed in a position to integrate this tool into their organisation’s environment in such a way, that the quality and the speed of CDISC data model transformations will be enhanced.
The Open Source Platform R is a powerful system for data analysis. This basic course gives insights into the basic principles of R under Windows. You will learn about the functionalities and application area of R. You will be trained in R with practical data and code examples, e.g. data import/-processing, create graphics and export analysis reports. At the end of the course you will be able to understand and generate simple R scripts, create graphics and reports in HTML format.