FDA Clinical Outcome Assessments and CDISC QRS supplements

by Shrishaila Patil

CDISC develops SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) QRS supplements that provide information on how to structure the data in a standard format for public domain and copyright-approved instruments. An instrument is a series of questions, tasks or assessments used in clinical research to provide a qualitative or quantitative assessment of a clinical concept or task-based observation. This Book is an effort to: - Understand QRS supplements & how it is developed;- Understand how to model ratings and scales other than questionnaires;- Understand ADaM Structure to be used for QRS supplements;- Understand different types of FDA Clinical Outcome Assessment (COA)'s; - Understand how CDISC QRS Supplements assist in structuring COA data so that it is collected and reported in a standardized format.