Course Description:

New to CDISC Standards? Attend our 3-hour workshop geared to getting you started with standards to amplify the full potential of data, drive operational efficiencies and expedite the regulatory review process. The workshop goes

Course Description:

New to CDISC Standards? Attend our 3-hour workshop geared to getting you started with standards to amplify the full potential of data, drive operational efficiencies and expedite the regulatory review process. The workshop goes over examples of the standards, along with how to build them into the process of writing a protocol, collecting and tabulating data, and using the data in analysis.  The CDISC Data Exchange standards are reviewed and the CDISC Library is discussed. 

The workshop also identifies standards strategies that can make the clinical research process more efficient and offers a high-level introduction into the current regulatory requirements for submissions.

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 Standards Development process, standards models, implementation guides and therapeutic area user guides to recognize their value in clinical research.
• Identify individual CDISC standards to set the stage for implementation.
• Support the adoption of implementing CDISC standards early in the clinical research process.
• Interpret CDISC Therapeutic Area User Guides in order to implement them across foundational standards
• Recognize how Define-XML organizes standards for as both machine-and human-readable metadata