This Therapeutic Area Data Standards User Guide for Nutritional Research (TAUG-Nutrition) was led NUT-48 - Getting issue details... STATUS by Nutrition companies under the Clinical Data Interchange Standards Consortium (CDISC) umbrella.
The goal of the Nutrition Therapeutic Area Data Standards project is to accelerate clinical research and nutrition products development by facilitating the creation and maintenance of data standards, tools, and methods for conducting research in therapeutic areas important to public health.
The purpose of this TAUG-Nutrition is to describe how to use CDISC standards to represent data pertaining to nutrition studies. This Version 1.0 focuses on infant nutrition, food and fluid intake, stool sampling, and questionnaires (specific to clinical studies in nutrition), and includes concepts for both adult and pediatric populations.
Nutrition concepts covered in this guide were selected from concepts identified by 1 or more nutrition stakeholders as important, and which were not addressed or not completely addressed by existing CDISC standards and implementation guides. This TAUG does not provide guidance on what data is needed for regulatory submission or approval; it only provides advice on how to represent data in a standard form. The examples included are intended to show how particular kinds of data can be represented using CDISC standards. Note: Examples are only examples and should not be over-interpreted.
This first version of the TAUG-Nutrition focuses on how to represent data using the Study Data Tabulation Model (SDTM). There are some examples of Clinical Data Acquisition Standards Harmonization (CDASH) implementation. Future versions of this guide may include additional CDASH and Analysis Data Model (ADaM) representations.