Clinical data quality checks for CDISC compliance using SAS

著者

    • Gupta, Sunil

書誌事項

Clinical data quality checks for CDISC compliance using SAS

Sunil Gupta

（A Chapman & Hall book）

CRC Press, c2020

  • : hardback

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注記

Includes bibliographical references (p. 141-143) and index

内容説明・目次

内容説明

Clinical Data Quality Checks for CDISC Compliance using SAS is the first book focused on identifying and correcting data quality and CDISC compliance issues with real-world innovative SAS programming techniques such as Proc SQL, metadata and macro programming. Learn to master Proc SQL's subqueries and summary functions for multi-tasking process. Drawing on his more than 25 years' experience in the pharmaceutical industry, the author provides a unique approach that empowers SAS programmers to take control of data quality and CDISC compliance. This book helps you create a system of SDTM and ADaM checks that can be tracked for continuous improvement. How often have you encountered issues such as missing required variables, duplicate records, invalid derived variables and invalid sequence of two dates? With the SAS programming techniques introduced in this book, you can start to monitor these and more complex data and CDISC compliance issues. With increased standardization in SDTM and ADaM specifications and data values, codelist dictionaries can be created for better organization, planning and maintenance. This book includes a SAS program to create excel files containing unique values from all SDTM and ADaM variables as columns. In addition, another SAS program compares SDTM and ADaM codelist dictionaries with codelists from define.xml specifications. Having tools to automate this process greatly saves time from doing it manually. Features SDTMs and ADaMs Vitals SDTMs and ADaMs Data CDISC Specifications Compliance CDISC Data Compliance Protocol Compliance Codelist Dictionary Compliance

目次

Overview of Data Quality and Compliance Checks SDTMs and ADaMs Vital Checks SDTMs and ADaMs Data Values Check CDISC Specification Compliance Checks CDISC Data Compliance Checks Protocol Compliance Checks Codelist Dictionary Compliance Checks Appendix

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