CDISC provides training on this standard: Virtual Classroom Training (New!) | Self-Paced Online Training
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CDISC Controlled Terminology is the set of CDISC-developed or CDISC-adopted standard expressions (values) used with data items within CDISC-defined datasets and is used throughout the clinical research lifecycle, from data collection through analysis and submission.
This half-day course will cover:
- Primary objectives, guiding principles
- Regulatory requirements for terminology
- Terminology use across foundational standards
- Accessing controlled terminology
- Basics of using terminology
- A discussion of codelist extensibility
- Terminology as Value Level Metadata
- How terminology is developed and maintained
- Requesting new terms
- Terminology in Therapeutic Area standards and SHARE
At the end of this course, you will be able to:
- Navigate online resources to access controlled terminology files.
- Describe the regulatory requirements for controlled terminology.
- Recognize various formats in which CT is published and understand the metadata associated with each CT concept.
- Request new terms, codelists, and changes to published terminology.
- Explain how controlled terminology is used in individual CDISC standards.
Continuing Education Units (CEUs)
Learners will receive 0.4 CEUs for successfully completing this course.
Successful Course Completion
- In order for a learner to successfully complete a course:
- An education representative or learner will complete training registration.
- A learner must attend course for 80% of total course time. Specific attendance requirements are posted in course information pages.
- A learner will complete final course assessment with a score of at least 80% correct.
- A learner will complete summative assessment surveys
- Remediation: The following requirements will be in effect if learner does not successfully complete all parts of training:
- If learner registers for course but fails to complete formative assessment in required time, learner will be notified that they must transfer registration to later date.
- If learner completes formative assessment but does not meet attendance requirement, learner will be notified that they must re-attend course in full.
- If learner meets attendance requirement in full but fails content assessment, learner is given a maximum of two additional re-attempts before being required to re-attend the course in full. Learner will be notified and will receive a certificate of attendance after the third failed assessment attempt.
- If learner successfully completes content assessment but fails to complete summative assessment, learner will be notified and CEUs will be on hold until summative assessment is completed.
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