Description
New to CDISC Standards? This 3-hour workshop will introduce the CDISC standards to help amplify the full potential of data, drive operational efficiencies, and expedite the regulatory review process.
The workshop 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 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.
The CDISC Data Exchange standards are reviewed, and the CDISC Library is discussed.
Learning Outcomes
After this course, you will be able to:
- 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.
- 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
Agenda
- Module 1: What is CDISC?
- Module 2: Why Are Standards Needed?
- Module 3: Overview of Regulatory Requirements
- Module 4: Overview of CDISC Models
- Module 5: CDISC Connects Research Globally
- Module 6: Therapeutic Area User Guides
- Module 7: Data Exchange Standards
- Module 8: Traceability
- Module 9: CDISC Library
- Module 10: How Can You Get Involved?
Continuing Education Units (CEUs)
This training does not offer CEUs.
Course Type
Private
Public
Course Length
3 Hours
Audience
Biostatistician
Clinician
Concept Modeler
CRF Designer
Data Manager
Medical Writer
Metadata Modeler
Nonclinical Study Personnel
Programmer
Standards Expert
Study Designer
Study Manager
System Architect
Technical Manager
Industry
Academic Institution
BioTech
Clinical Laboratory
Consulting
CRO
Government
Healthcare Provider
Medical Device
NPO
Pharmaceutical
Technology Service Provider