Training Description
CDISC Controlled Terminology (CT) 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 and guiding principles of CDISC CT
· Regulatory requirements for the use of controlled terminologies
· Terminology use across foundational standards
· Accessing CDISC CT
· Understanding terminology metadata and discussion of codelist extensibility
· Description of and access to supplemental terminology products
· Terminology as Value Level Metadata
· How CDISC CT is developed and maintained
· An introduction to the CDISC change request system