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portada FDA Clinical Outcome Assessments and CDISC QRS supplements
Type
Physical Book
Author
Publisher
Language
English
Pages
64
Format
Paperback
Dimensions
22.9 x 15.2 x 0.4 cm
Weight
0.10 kg.
ISBN13
9786200454768
Categories

FDA Clinical Outcome Assessments and CDISC QRS supplements

Shrishaila Patil (Author) · LAP Lambert Academic Publishing · Paperback

FDA Clinical Outcome Assessments and CDISC QRS supplements - Patil, Shrishaila

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Synopsis "FDA Clinical Outcome Assessments and CDISC QRS supplements"

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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