FDA Clinical Outcome Assessments and CDISC QRS supplements

Zusatztext

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.

Autorenportrait

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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