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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
Verlag: LAP LAMBERT Academic Publishing, 2019

Inhaltsangabe

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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Über die Autorin bzw. den Autor

Shrishaila Patil, Vice President of Statistical Programming, manages a group of statistical programmers at Navitas Data Sciences. He also acts as PhUSE India Membership officer. He has more than 15 years of experience across Drug development which includes Bioinformatics, Clinical DB Setup, Statistical programming (SDTM, ADaM and TLF Programming).

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Verlag
LAP LAMBERT Academic Publishing
Erscheinungsdatum
2019
Sprache
Englisch
ISBN 10 
6200454760
ISBN 13 
9786200454768
Einband
Taschenbuch
Anzahl der Seiten
64
Kontakt zum Hersteller
Nicht verfügbar
Verantwortliche Person
KreGa Onlinehandel GmbH
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