FDA Clinical Outcome Assessments and CDISC QRS supplements (Paperback) (ISBN-13: 9786200454768)

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.

Author: Shrishaila Patil
ISBN-10: 6200454760
ISBN-13: 9786200454768
Publisher: LAP Lambert Academic Publishing
Language: English
Published: 10/22/2019
Pages: 64
Format: Paperback
Weight: 0.23lbs
Size: 9.00h x 6.00w x 0.15d