CDISC Alzheimer’s Disease Therapeutic Area Data Standard User Guide v 2.0 Now Available for Public Review – Comments Due 6 November 2013
The CFAST Alzheimer’s team is pleased to announce the availability of the Alzheimer’s v 2.0 Draft Data Standard for a 30-day public review. The CDISC Alzheimer’s User Guide describes the most common clinical concepts relevant to studies of Alzheimer’s disease and Mild Cognitive Impairment, and shows examples of how these concepts are represented in the Study Data Tabulation Model (SDTM). The content of this update focuses on three major areas: cognition, cerebrospinal fluid biomarkers, and imaging biomarkers (volumetric MRI, FDG-PET and amyloid imaging via PET/CT). Additionally, some content represented in v 1.0 has been updated to reflect current conventions in SDTM. This version is intended to completely replace v 1.0.
This content of this guide was developed with clinical/scientific subject matter expert input from several members of CAMD.
Reviewers are asked to comment on the both the content and organization of the document as it presents a new organization for CDISC user guides. Please submit your comments using the CDISC commenting tool located on the CDISC website located here.
Click here to download the user guide. **Please note that this document can only be viewed with Adobe Reader 6.0 or a more updated version of Adobe. The current version of Adobe Reader can be downloaded for free through this link. Please try to open the file with a different viewer and save it to your computer to access the full user guide.**
For more info on CDISC, please visit www.cdisc.org