Title Clinical data quality checks for CDISC compliance using SAS / by Sunil Gupta

Published Boca Raton, FL : CRC Press, Taylor & Francis, [2020]

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Description 1 online resource Contents Cover; Half Title; Title Page; Copyright Page; Table of Contents; Preface; Acknowledgments; Author; Chapter 1: Overview of Data Quality and Compliance Checks; INTRODUCTION; 1.1 LEVEL OF CHECKS TO APPLY; 1.1.1 SDTMs and ADaMs Vitals; 1.1.2 SDTMs and ADaM Data; 1.1.3 CDISC Specifications Compliance; 1.1.4 CDISC Data Compliance; 1.1.5 Protocol Compliance; 1.1.6 Codelist Dictionary Compliance; 1.2 WHEN TO APPLY CHECKS; 1.2.1 Database Acceptance and Lock; 1.2.2 SDTMs and ADaMs Refresh; 1.2.3 Snapshot Analysis; 1.3 CUSTOMIZED CHECKS FOR EACH CLIENT; 1.3.1 Site Management; 1.3.2 Data Management 1.3.3 SAS Programmers1.3.4 Statisticians; SUMMARY; Chapter 2: SDTMs and ADaMs Vital Checks; INTRODUCTION; 2.1 DATASET VITALS; 2.2 DATA TRANSFERS; 2.3 GROUP DESCRIPTIVE STATISTICS; 2.4 ZERO DATASET RECORDS; 2.5 DISPOSITION POPULATION TREES (SAFFL, ITTFL); 2.6 SDTM ONCOLOGY DOMAIN; SUMMARY; Chapter 3: SDTMs and ADaMs Data Checks; INTRODUCTION; 3.1 DUPLICATE RECORDS; 3.2 MISSING VALUES IN REQUIRED VARIABLES; 3.3 VARIABLE UNIQUE COUNTS; 3.4 ISO8601 DATETIME AND TIME; 3.5 DURATION; 3.6 DATA RANGE; 3.7 NEGATIVE VALUES; 3.8 NUMERIC OUTLIERS; 3.9 COMPARE RELATED VARIABLES 3.10 CALCULATIONS AND DERIVED VARIABLE3.11 LAB DATA; SUMMARY; Chapter 4: CDISC Specification Compliance Checks; INTRODUCTION; 4.1 CONSISTENCY BETWEEN DM SPECIFICATIONS AND ATTRIBUTES (TYPE, NAME, LENGTH, LABEL); 4.2 NON-MISSING DATASET LABEL; 4.3 NO PERMANENT FORMAT IN DM; 4.4 DM CORRECT ORDER OF VARIABLES; 4.5 VARIABLE LENGTH IS MAXIMUM OF VALUES OR 200; SUMMARY; Chapter 5: CDISC Data Compliance Checks; INTRODUCTION; 5.1 SDTM CONSISTENCY; 5.1.1 AENUM and CENUM; 5.1.2 AE. AESEQ and SUPPAE. IDVARVAL; 5.1.3 Orphan Records in SUPPXX; 5.1.4 DOMAIN Variable and Name 5.1.5 Required SDTM Domains (TA, DM, EX and DS) Do Not Exist5.1.6 Required ADaMs (ADSL) Do Not Exist; 5.1.7 SE Start and End Dates Sequence Requirement; 5.2 ADaM CONSISTENCY; SUMMARY; Chapter 6: Protocol Compliance Checks; INTRODUCTION; 6.1 USUBJID MISSING IN DM/ADSL; 6.2 MISSING EXPOSURE RECORD IN EX FOR DM USUBJID; 6.3 LAB DATA BASELINE; 6.3.1 Incorrect ADBLFL Baseline Flag Record; 6.3.2 No Baseline Result for VS, LB, EG, DA; 6.4 DISPOSITION TREE CHECK -- ONE-PROC AWAY; SUMMARY; Chapter 7: Codelist Dictionary Compliance Checks; INTRODUCTION; 7.1 CODELIST, VALUE-LEVEL CHECKS AND LOOKUP TABLES 7.2 CODELIST AND VALUE-LEVEL UPPERCASESUMMARY; APPENDIX; REFERENCES; INDEX Summary "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"-- Provided by publisher Bibliography Includes bibliographical references and index Notes Print version record and CIP data provided by publisher SUBJECT SAS (Computer file) http://id.loc.gov/authorities/names/n88028236 SAS (Computer file) fast Subject Medical care -- Standards -- United States Medical care -- United States -- Quality control MEDICAL -- Pharmacology. MEDICAL -- Biostatistics. Medical care -- Quality control Medical care -- Standards United States Form Electronic book LC no. 2019023652 ISBN 9780429345043 0429345046 9781000698329 1000698327 9781000699043 1000699048 9781000698688 1000698688

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