Course Description
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 training will cover the following topics:
- 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