Parkinson’s Disease Therapeutic Area User Guide v1.0
Version 1.0 Provisional of the Parkinson’s Disease Therapeutic Area User Guide (TAUG-PD), released 2012-12-18 and developed in collaboration between CDISC and The National Institute for Neurological Disorders and Stroke (NINDS) 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.
|Parkinson’s Disease Therapeutic Area User Guide v1||3.8 MB|