Upcoming Public Training Opportunities: TBD
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
Learning Outcomes for this course include:
- At the end of this course, the user will be able to navigate online resources to access controlled terminology files.
- At the end of this course, the user will be able to describe the regulatory requirements for controlled terminology.
- At the end of this course, the user will be able to recognize various formats in which CT is published and understand the metadata associated with each CT concept.
- At the end of this course, the user will be able to request new terms, codelists, and changes to published terminology.
- At the end of this course, the user will be able to 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 will complete formative assessment survey
- 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.
CDISC also offers this course through Private Training and Licensed Training.