Version 1.0 of the Polycystic Kidney Disease Therapeutic Area User Guide (TAUG-PKD), was developed under the CDISC Standards Development Process. TAUG-PKD describes the most common biomedical concepts relevant to PKD, and the necessary metadata to represent such data consistently with Terminology and SDTM.
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 polycystic kidney 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.