Parkinson’s Disease Therapeutic Area User Guide v1.0

Release Date: 18 Dec 2012

Version 1.0 of the Parkinson’s Disease Therapeutic Area User Guide (TAUG-PD) was developed in collaboration with CDISC and The National Institute for Neurological Disorders and Stroke (NINDS). TAUG-PD provides guidance on the implementation of the Study Data Tabulation Model (SDTM) to represent Parkinson's Disease (PD) data in regulatory submissions. When used with the SDTMIG, TAUG-PD is intended to guide the organization, structure, and format of standard PD clinical trial tabulation datasets submitted to a regulatory authorities. TAUG-PD provides background on the PD standards, along with specific implementations for NINDS PD CRFs in existing SDTMIG standard, provisional and draft domains.

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.

Application of CDISC Standards has supported the discovery of clinical research biomarkers for Parkinson’s Disease — the evidence for which had been hidden in non-standardized datasets for years prior to their standardization, aggregation, and analysis. These biomarkers now enable researchers to identify diseases early, when intervention may be possible.