Introduction to CDISC On-Demand Training

Agenda:

• Introduction Module (1:40)
• Module 1: What Is CDISC? (6:00)
• Module 2: Why Are Standards Needed? (5:00)
• Module 3: Overview of Regulatory Requirements (15:06)
• Module 4: Overview of CDISC Models (Parts 1, 2, & 3)
  • Part 1 Video: 9:47
  • Part 2 Video: 20:16
  • Part 3 Video: 7:48
• Module 5: CDISC Connects Research Globally (2:32)
• Module 6: Therapeutic Area User Guides (5:16)
• Module 7: Data Exchange Standards (7:25)
• Module 8: Traceability (2:48)
• Module 9: CDISC Library (4:22)
• Module 10: Joining the CDISC Community (4:29)

Total video content: 1 hour, 32 minutes, and 29 seconds

1. Explain the foundational purpose of CDISC standards and how standardized data structures directly improve global research efficiency and regulatory submissions.
2. Identify core CDISC models and data exchange standards to understand where each fits within the end-to-end flow of clinical study data.
3. Describe the role of specialized tools—including Therapeutic Area User Guides (TAUGs) and the CDISC Library—in managing and optimizing clinical research metadata.
4. Recognize how data traceability is maintained from initial patient data collection through to final analysis and submission.
5. Identify pathways to engage with the global CDISC community for ongoing professional support, collaboration, and learning.

Module 1 (What Is CDISC?): Describe the CDISC as an organization

Module 2 (Why are Standards Needed?): Describe the basics of clinical research data standards and why they are essential

Module 3 (Overview of Regulatory Requirements): Describe the value of CDISC standards to regulators

Module 4 (Overview of CDISC Models): Describe the CDISC foundational standards and where each fits in the flow of study data

Module 5 (CDISC Connects Research Globally): Discuss the value that CDISC standardization brings to global research

Module 6 (Therapeutic Area User Guides): Describe the role of CDISC standards in defining therapeutic area-based data user guides

Module 7 (Data Exchange Standards): Explain the role of data exchange standards in the CDISC standards ecosystem

Module 8 (Traceability): Define traceability and explain how CDISC standards support full traceability

Module 9 (CDISC Library): Access the CDISC Library, demonstrate how to navigate within it, and identify the characteristics and benefits of using a Metadata Repository (MDR)

Module 10 (Joining the CDISC Community): Identify ways to engage in the global CDISC community