For the approval of medication or other medical products, clinical studies are confronted with specialised requirements for the management and analyses of data.
This is, for one thing, a result of the „Good Clinical Practice“-guideline for the performance of clinical studies. However, since the management and analysis of data is a question of electronic records and automated systems, this too must be validated.
The participants will understand the concepts behind software validation and electronic records, and how they apply to clinical studies. Furthermore, they will acquire specific approaches for the validation of SAS programmes. This course does not offer a complete in it self closed process model, as this should be established specifically for the organisation.
The participants should have knowledge in the performance of clinical studies in accordance to Good Clinical Practice (ICH E6), as well as Programming with Base SAS (GKPRO or GKEP) and Macro Programming (MACRO) and/or equivalent experience with SAS programming.
This course is directed at programmers and statisticians in pharmaceutical and research organisations who are involved with data management and/or data analyses of clinical studies, and use SAS for this purpose.
Base SAS Software
As a training partner of SAS we operate this course. For further information on our training offers as well as the individual workshops please contact firstname.lastname@example.org. If you want to book a course directly via SAS, please click here.