Alzheimer’s Therapeutic Area User Guide v2.0
(TA Version) Version 2.0 of the Alzheimer’s Disease Therapeutic Area User Guide (TAUG-Alzheimer's), released 2013-12-16, provides guidance on implementing the Study Data Tabulation Model (SDTM) to represent Alzheimer’s data in regulatory submissions. 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.
|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 Provisional of the Alzheimer's Disease-specific Therapeutic Area Supplement User Guide, released 2011-09-09, to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials 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.