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.
Learning Outcomes
At the end of this course, learners will be able to:
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
Course 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?
Prerequisites
No prerequisites required; a range of background knowledge and skills among students is common.
Enrollment Confirmation
After enrolling in a virtual training, you will automatically receive a Confirmation Email with the following:
an order number
link to the CDISC Learning Management System (LMS)
You can immediately access the online training materials in the LMS.
Within 24 hours, you will be assigned to your specific virtual Zoom seminar event.
You will receive a Training Booking Confirmation Email from noreply_training@cdisc.org with the following:
event details (including a Zoom meeting link)
an iCal attachment
Please contact us if you do not receive these emails within 24 hours.
