Clinical Data Quality Checks for CDISC Compliance Using SAS 1st Edition by Sunil Gupta 1000699043 9781000699043

Clinical Data Quality Checks for CDISC Compliance Using SAS 1st Edition by Sunil Gupta – Ebook PDF Instant Download/DeliveryISBN:  1000699043, 9781000699043 

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ISBN-10 :  1000699043 

ISBN-13 :  9781000699043

Author:  Sunil Gupta 

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

Clinical Data Quality Checks for CDISC Compliance Using SAS 1st Table of contents:

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 Programmers
1.3.4 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 VARIABLE
3.11 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 Exist
5.1.6 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 UPPERCASE

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