Description:

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.

 

Course Agenda:

  • Topic 1: What is CDISC?​
  • Topic 2: Why Are Standards Needed?​
  • Topic 3: Overview of Regulatory Requirements​
  • Topic 4: Overview of CDISC Models​
  • Topic 5: CDISC Connects Research Globally​
  • Topic 6: Therapeutic Area User Guides​
  • Topic 7: Data Exchange Standards​
  • Topic 8: Implementing CDISC Standards​
  • Topic 9: CDISC SHARE​
  • Topic 10: How Does CDISC Work?

 

Learning Outcomes:

  • Describe the CDISC organization, its development processes, and its standards models in order to recognize their value in clinical research.​
  • Identify individual CDISC standards in order to set the stage for implementation.​
  • Support the adoption of implementing CDISC standards early in the clinical research process.
Course Length: 
3 Hours
Course Type: 
Public, Private
Audience: 
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
Industry: 
Academic Institution, BioTech, Clinical Laboratory, Consulting, CRO, Government, Healthcare Provider, Medical Device, NPO, Pharmaceutical, Technology Service Provider