FDA Clinical Outcome Assessments and CDISC QRS supplements. Enabling Patient-Centric Drug Development

      Аннотация: 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.

Ключевые слова: FDA, Clinical Outcome Assessments PRO COA CDISC QRS