Controlled Terminology Implementation

According to CDISC:

Controlled Terminology is the set of codelists and valid values used with data items within CDISC-defined datasets. Controlled Terminology provides the values required for submission to FDA and PMDA in CDISC-compliant datasets. Controlled Terminology does not tell you WHAT to collect; it tells you IF you collected a particular data item, HOW you should submit it in your electronic dataset.

But some critical difficulties must be faced when CDISC decides to publish an update of its Controlled Terminology. For instance, the SDTM standards and the Controlled Terminally updates are not released at the same time and at the same pace (years for SDTM major releases and months for the Controlled Terminology ones). Therefore it can be a tedious task to assign, for instance, a value to variables that have not yet been officially validated by the FDA, and to navigate between the various and numerous SDTM drafts published by CDISC. But somes other issues can be far more complex...

STDM Standards and Controlled Terminology Updates Issues

Hence, one of the toughest challenges when creating an SDTM package or maintaining an SDTM compliant Metadata Repository is the ability to easily and securely update its Controlled Terminology. Thanks to its renowned expertise based on a unique, deep knowledge of CDISC, and innovative processes and software tools, AdClin can help you addressing issues related to STDM Standards and Controlled Terminology Updates:

• Witch SDTM variable matches the new implemented values/codelists (or vice versa)?
• What values or variables (not yet published by CDISC) should be created in regard to your current studies?
• What should be done when former official values or codelists disappear?
• How to easily and securely implement recently published values and codelists versus the ones already in place in your SDTM datasets?
• How to create and maintain a Metadata Repository containing the information needed to monitor all Controlled Terminology standards and updates?

AdClin: A Range of High-added Value Consulting Services

In order to address these issues we provide three main custom services:

In all cases, AdClin will help you creating and maintaining state of the art CDISC compliant Metadata Repository and Datasets that matches the most recent FDA’s requirements and policies.