Controlled Terminology

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

Continuing Education Units (CEUs)

The learner must receive a score of 80% or higher on the Final Assessment to earn 0.4 CEUs.