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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.
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