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Functional Tests and Questionnaires

CDISC publishes standard Questionnaire and Functional Test Supplements to the SDTMIG along with controlled terminology.  All standard supplement development is coordinated with the CDISC SDTM QS/FT Sub-Team as the governing body.  The process involves drafting the controlled terminology and defining specific standardized values for Qualifier, Timing, and Result variables to populate the SDTM QS or FT Domain.  All –TESTCD/--TEST controlled terminology is governed by the QS/FT Controlled Terminology Sub-Team.  The Questionnaire and Functional Test Supplements are developed based on user demand and therapeutic area standards development needs.  Sponsors need to always consult the CDISC website to review the QS/FT terminology and supplements prior to modeling any data in the QS or FT Domain.  Sponsors may participate and/or request the development of additional supplements and terminology through the CDISC SDTM QS/FT Sub-Team or the QS/FT Controlled Terminology Sub-Team.  CDISC COP-017 describes this process.  When approved by the QS/FT Sub-Team, the QS or FT Supplement is posted on the this page.

Questionnaires: Questionnaires are named, stand-alone instruments designed to provide an assessment of a concept.  Questionnaires have a defined standard structure, format, and content; consist of conceptually related items that are typically scored; and have documented methods for administration and analysis.  Most often, questionnaires have as their primary purpose the generation of a quantitative statistic to assess a qualitative concept.  They may be documented in the public domain or are owned by a copyright holder.

Functional Tests: Functional tests are named, stand-alone task-based evaluations designed to provide an assessment of mobility, dexterity, and/or cognitive ability. A functional test is not a subjective assessment of how the subject generally performs a task. Rather it is an objective measurement of the performance of the task by the subject in a specific instance. Functional tests have documented methods for administration and analysis and require a subject to perform specific activities that are evaluated and recorded. Most often, functional tests are direct quantitative measurements. They may be documented in the public domain or be owned by a copyright holder.