Description:

This is a classroom course designed for newcomers to CDISC.  The course commences with an introduction to the CDISC organization, and provides an overview of the CDISC standards and their value in clinical research. It then gives

Description:

This is a classroom course designed for newcomers to CDISC.  The course commences with an introduction to the CDISC organization, and provides an overview of the CDISC standards and their value in clinical research. It then gives concrete examples of what the standards look like and how to build them into the process of writing a protocol, collecting and tabulating data, and using the data in an analysis.  The CDISC Data Exchange standards are reviewed and the CDISC Library is discussed.  The course also identifies implementation approaches that can make the process of clinical research more efficient, and offers 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 Library
• 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.