This 3-hour virtual training introduces the CDISC Standards to help amplify the full potential of data, drive operational efficiencies, and expedite the regulatory review process.
The training offers 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 training 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.
The CDISC Data Exchange standards are reviewed, and the CDISC Library is discussed.
No prerequisites required; a range of background knowledge and skills among students is common.
- 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
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?
CDISC for Newcomers (VIRTUAL)
09:00-12:00 ET - Zoom
|CDISC for Newcomers (VIRTUAL)||05-Sep-23||US||09:00-12:00 ET - Zoom||$420.00|