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Alzheimer’s Therapeutic Area User Guide v2.0

Release Date: 16 Dec 2013

(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.

PDF icon taug_alzheimer__s_v2.0.pdf3.65 MB

SDTM Alzheimer's Disease/Mild Cognitive Impairment User Guide v1.0

Release Date: 9 Sep 2011

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.