Training Schedule Options (click on 'Read more...' to view all options)
The CDISC for Newcomers virtual training consists of 3 contact hours (1 scheduled day of live Zoom instruction at 3 hours total). The CDISC Education Team will email all
Training Schedule Options (click on 'Read more...' to view all options)
The CDISC for Newcomers virtual training consists of 3 contact hours (1 scheduled day of live Zoom instruction at 3 hours total). The CDISC Education Team will email all registered participants a Zoom link one week prior to the start of training.
See below for full breakdown of options:
Option: USA
Training Date: 25 October
(3-hour virtual Zoom session)
Time: 2:00pm-5:00pm
US Eastern Time
Language: English
| Option: Japan
Training Date: 6 December
(3-hour virtual Zoom session)
Time: 2:00pm-5:00pm
Japan Standard Time
Language: Japanese
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*Trainings will be rescheduled or cancelled if minimum enrollment requirements are not met.
Course 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.
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
