This is a classroom course designed for a newcomers to CDISC. The course commences with an introduction to the CDISC organization and will provide an overview of the CDISC standards and their value in clinical research, give concrete examples of what the standards look like and how to build them into the process of writing a protocol, collecting data and using the data in an analysis. The CDISC Data Exchange standards are reviewed and the SHARE platform will be discussed. It also identifies implementation approaches to make the process of clinical research more efficient and a high-level introduction into the current regulatory requirements for submissions.
Biostatistician, Clinician, Concept Modeler, CRF Designer, Data Manager, Medical Writer, Metadata Modeler, Nonclinical Study Personnel, Programmer, Standards Expert, Study Designer, Study Management, System Architect, Technical Manager
Academic Institution, BioTech, Clinical Laboratory, Consulting, CRO, Government, Healthcare Provider, Medical Device, NPO, Pharmaceutical, Technology Service Provider