Version 2.0 of the Alzheimer’s Disease Therapeutic Area User Guide (TAUG-Alzheimer's) was developed under the CDISC Standards Development Process. TAUG-Alzheimer’s v2.0 describes the most common biomedical concepts relevant to studies of Alzheimer’s disease and mild cognitive impairment, and the necessary metadata to represent such data consistently with Terminology and SDTM.
Users wishing to implement this TAUG alongside SDTMIG v3.3 should be aware of the following:
- The addition of MHEVTYP replaces the usage of MHCAT as described in the UG.
- With the deprecation of the MO domain, the NV domain should be used for all physiological and morphological findings related to the nervous system.
TA Standards extend the Foundational Standards to represent data that pertain to specific indications within disease areas. CDISC Standards specify how to structure the data; they do not specify what data should be collected or how to conduct clinical trials, assessments or endpoints.
Public Review Comments
CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.