Implementing CDISC Using Sas: An End-To-End Guide

Format:

Book

Author/Creator:

Holland, Chris, Author.

Contributor:

Shostak, Jack, Contributor.

SAS Institute.

Language:

English

Subjects (All):

SAS (Computer file).

Information Technology--General and Others.

Local Subjects:

Information Technology--General and Others.

Physical Description:

1 online resource (1 v.) : ill.

Edition:

1st edition

Other Title:

Implementing Clinical Data Interchange Standards Consortium using SAS

Place of Publication:

[Place of publication not identified] SAS Institute 2012

Language Note:

English

System Details:

text file

Summary:

For decades researchers and programmers have used SAS to analyze, summarize, and report clinical trial data. Now Chris Holland and Jack Shostak have written the first comprehensive book on applying clinical research data and metadata to the Clinical Data Interchange Standards Consortium (CDISC) standards. Implementing CDISC Using SAS: An End-to-End Guide is an all-inclusive guide on how to implement and analyze Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) data and prepare clinical trial data for regulatory submissions. Topics covered include creating and using metadata, developing conversion specifications, implementing and validating SDTM and ADaM data, determining solutions for legacy data conversions, and preparing data for regulatory submission. The book covers products such as Base SAS, SAS Clinical Data Integration, and the SAS Clinical Standards Toolkit, as well as JMP Clinical. Anyone dealing with CDISC standards--including SAS or JMP programmers, statisticians, and data managers in the pharmaceutical, biotechnology, or medical device industries--will find the philosophical best practices and implementation examples in this book invaluable. This book is part of the SAS Press program.

Contents:

Implementation strategies

SDTM metadata and define.xml for base SAS implementation

Implementing the CDISC SDTM with Base SAS

Implementing CDISC SDTM with the SAS clinical standards toolkit and base SAS

Implementing the CDISC SDTM with SAS clinical data integration

ADaM metadata and ADaM define.xml

Implementing ADaM

SDTM validation

Validating ADaM data

CDISC data review and analysis

Integrated data and regulatory submissions

Other topics.

Notes:

Bibliographic Level Mode of Issuance: Monograph

ISBN:

9781607648888

1607648881

OCLC:

846954560