Controlled Terminology

CDISC provides public training on this standard via: Virtual Classroom Training | On-Demand Online Training

Interested in 'private, on-site' training for your team? Contact us today.

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 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 CDISC Library
Learning Outcomes

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
  1. In order for a learner to successfully complete a course:
    1. An education representative or learner will complete training registration.
    2. A learner must attend course for 80% of total course time. Specific attendance requirements are posted in course information pages.
    3. A learner will complete final course assessment with a score of at least 80% correct.
    4. A learner will complete summative assessment surveys
  2. Remediation: The following requirements will be in effect if learner does not successfully complete all parts of training:
    1. 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.
    2. If learner completes formative assessment but does not meet attendance requirement, learner will be notified that they must re-attend course in full.
    3. 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.
    4. 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.
Course Type

Online
Private
Public
Virtual Classroom

Course Length

1/2 Day

Audience

Biostatistician
CRF Designer
Data Manager
Programmer

Industry

Academic Institution
BioTech
Clinical Laboratory
Consulting
CRO
Government
Healthcare Provider
Medical Device
NPO
Pharmaceutical
Technology Service Provider