Items related to FDA Clinical Outcome Assessments and CDISC QRS supplements:...

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

Patil, Shrishaila

 
9786200454768: FDA Clinical Outcome Assessments and CDISC QRS supplements: Enabling Patient-Centric Drug Development
Softcover
ISBN 10: 6200454760 ISBN 13: 9786200454768
Publisher: LAP Lambert Academic Publishing, 2019

Synopsis

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.

"synopsis" may belong to another edition of this title.

Publisher
LAP Lambert Academic Publishing
Publication date
2019
Language
English
ISBN 10 
6200454760
ISBN 13 
9786200454768
Binding
Paperback
Number of pages
64