Controlled Terminology

Despite continuous development of, and the quarterly updates to, CDISC Controlled Terminology, there is still a need for study-specific extensions to standard codelists.

Often, extensions to standard terminology are incorrect. For example, some users falsely believe that any new terms can be added to an extensible codelist and related data validation is not needed if new terms are listed in the define.xml. In this webinar, Sergiy Sirichenko will summarize industry metrics across many studies and sponsors to produce an overall picture of CDISC Controlled Terminology utilization. He will review common issues with implementation of controlled terminology and reinforce best practices for extending standard codelists.

Controlled Terminology have you confused? We got you.

When starting a new clinical study and preparing the data collection design, you may ask yourself: How important is Controlled Terminology (CT)? How do I prepare the data collection process to be CDISC compliant and avoid rework for submissions? We often receive questions such as these. Whether you are newer to clinical studies or a seasoned veteran, CT can often be an elusive and confusing topic. Having a better understanding of CT standards and requirements, as well as CT-related issues found in validation checks, can improve your submission data and processes.