Alzheimer’s Therapeutic Area User Guide v2.0
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 CDISC standards, such as SDTM.
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.
CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.
|TAUG-Alzheimer v2 (single file)||3.65 MB|
|CDISC Alzheimer’s Disease v2 Public Review Comments||29.25 KB|
SDTM Alzheimer's Disease/Mild Cognitive Impairment User Guide v1.0
Version 1.0 of the Alzheimer's Disease Therapeutic Area Supplement User Guide to the Study Data Tabulation Model Implementation Guide was developed in collaboration between CDISC and the Coalition Against Major Diseases (CAMD) - a program of the Critical Path Institute. This user guide describes how to implement SDTM safety domains related to Alzheimer's disease (AD)/Mild Cognitive Impairment (MCI) clinical trials.