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Author: Chris Holland
Publisher: SAS Institute
ISBN: 1642952419
Category : Computers
Languages : en
Pages : 294
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Book Description
For decades researchers and programmers have used SAS to analyze, summarize, and report clinical trial data. Now Chris Holland and Jack Shostak have updated their popular Implementing CDISC Using SAS, 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, Revised Second Edition, is an all-inclusive guide on how to implement and analyze the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM) data and prepare clinical trial data for regulatory submission. Updated to reflect the 2017 FDA mandate for adherence to CDISC standards, this new edition covers 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. Topics included in this edition include an implementation of the Define-XML 2.0 standard, new SDTM domains, validation with Pinnacle 21 software, event narratives in JMP Clinical, STDM and ADAM metadata spreadsheets, and of course new versions of SAS and JMP software. The second edition was revised to add the latest C-Codes from the most recent release as well as update the make_define macro that accompanies this book in order to add the capability to handle C-Codes. The metadata spreadsheets were updated accordingly. Any manager or user of clinical trial data in this day and age is likely to benefit from knowing how to either put data into a CDISC standard or analyzing and finding data once it is in a CDISC format. If you are one such person--a data manager, clinical and/or statistical programmer, biostatistician, or even a clinician--then this book is for you.
Author: Chris Holland
Publisher: SAS Institute
ISBN: 1642952419
Category : Computers
Languages : en
Pages : 294
Get Book
Book Description
For decades researchers and programmers have used SAS to analyze, summarize, and report clinical trial data. Now Chris Holland and Jack Shostak have updated their popular Implementing CDISC Using SAS, 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, Revised Second Edition, is an all-inclusive guide on how to implement and analyze the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM) data and prepare clinical trial data for regulatory submission. Updated to reflect the 2017 FDA mandate for adherence to CDISC standards, this new edition covers 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. Topics included in this edition include an implementation of the Define-XML 2.0 standard, new SDTM domains, validation with Pinnacle 21 software, event narratives in JMP Clinical, STDM and ADAM metadata spreadsheets, and of course new versions of SAS and JMP software. The second edition was revised to add the latest C-Codes from the most recent release as well as update the make_define macro that accompanies this book in order to add the capability to handle C-Codes. The metadata spreadsheets were updated accordingly. Any manager or user of clinical trial data in this day and age is likely to benefit from knowing how to either put data into a CDISC standard or analyzing and finding data once it is in a CDISC format. If you are one such person--a data manager, clinical and/or statistical programmer, biostatistician, or even a clinician--then this book is for you.
Author: Sunil Gupta
Publisher: CRC Press
ISBN: 1000699048
Category : Medical
Languages : en
Pages : 156
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Book Description
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
Author: Carol I. Matthews
Publisher: SAS Institute
ISBN: 1599941287
Category : Computers
Languages : en
Pages : 229
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Book Description
This indispensable guide focuses on validating programs written to support the clinical trial process from after the data collection stage to generating reports and submitting data and output to the Food and Drug Administration.
Author: Chris Holland
Publisher: Sas Inst
ISBN: 9781612901657
Category : Computers
Languages : en
Pages : 264
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Book Description
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.SAS Products and Releases: Base SAS: 9.3 JMP: 9.0.2, 10.0.2, 10.0.1, 10.0 JMP Clinical: 4.0, 3.1, 3.0, 2.1 SAS Clinical Data Integration: 2.3 SAS Clinical Standards Toolkit: 1.4, 1.3, 1.2 Operating Systems: All
Author: Chris Holland
Publisher:
ISBN: 9781642952230
Category : Computers
Languages : ko
Pages : 308
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Book Description
For decades researchers and programmers have used SAS to analyze, summarize, and report clinical trial data. Now Chris Holland and Jack Shostak have updated their popular Implementing CDISC Using SAS, 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, Second Edition, is an all-inclusive guide on how to implement and analyze the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM) data and prepare clinical trial data for regulatory submission. Updated to reflect the 2017 FDA mandate for adherence to CDISC standards, this new edition covers 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. Topics included in this new edition include an implementation of the Define-XML 2.0 standard, new SDTM domains, validation with Pinnacle 21 software, event narratives in JMP Clinical, and of course new versions of SAS and JMP software. Any manager or user of clinical trial data in this day and age is likely to benefit from knowing how to either put data into a CDISC standard or analyzing and finding data once it is in a CDISC format. If you are one such person--a data manager, clinical and/or statistical programmer, biostatistician, or even a clinician--then this book is for you.
Author: Duolao Wang
Publisher: Remedica
ISBN: 1901346722
Category : Medical
Languages : en
Pages : 497
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Book Description
This book explains statistics specifically for a medically literate audience. Readers gain not only an understanding of the basics of medical statistics, but also a critical insight into how to review and evaluate clinical trial evidence.
Author: Y. LAKSHMI PRASAD
Publisher: Notion Press
ISBN: 9384381896
Category :
Languages : en
Pages : 459
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Book Description
An indispensable guide to SAS Clinical Programming, this book is the first guide on this topic, to be written by an Indian author. Written in an instructive and conversational tone for people who want to make their career in SAS Clinical Programming and entry level programmers for their day-to-day tasks. It is equipped with practical, real world examples, detailed description of programs, work flows, issues, resolutions and key techniques. This book is a personal SAS Clinical trainer. It explains the art of SAS Clinical Programming in eighteen easy steps, covering everything from basics to ADS, TLF Creation, as well as CDISC SDTM and ADaM specifications. Many statistical concepts are explained in an easy way so that you feel confident while using Statistical Procedures. If you are already working as a SAS Clinical Programmer, this book will aid you with sharpening your skills.
Author: Jack Shostak
Publisher: SAS Institute
ISBN: 1629591491
Category : Computers
Languages : en
Pages : 308
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Book Description
This comprehensive resource provides on-the-job training for statistical programmers who use SAS in the pharmaceutical industry This one-stop resource offers a complete review of what entry- to intermediate-level statistical programmers need to know in order to help with the analysis and reporting of clinical trial data in the pharmaceutical industry. SAS Programming in the Pharmaceutical Industry, Second Edition begins with an introduction to the pharmaceutical industry and the work environment of a statistical programmer. Then it gives a chronological explanation of what you need to know to do the job. It includes information on importing and massaging data into analysis data sets, producing clinical trial output, and exporting data. This edition has been updated for SAS 9.4, and it features new graphics as well as all new examples using CDISC SDTM or ADaM model data structures. Whether you're a novice seeking an introduction to SAS programming in the pharmaceutical industry or a junior-level programmer exploring new approaches to problem solving, this real-world reference guide offers a wealth of practical suggestions to help you sharpen your skills. This book is part of the SAS Press program.
Author: Jack Shostak
Publisher:
ISBN: 9781590477939
Category : Electronic books
Languages : en
Pages : 0
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Book Description
This real-world reference for clinical trial SAS programming is packed with solutions that can be applied day-to-day problems. Organized to reflect the statistical programmers workflow, this user-friendly text begins with an introduction to the working environment, then presents chapters on importing and massaging data into analysis data sets, producing clinical trial output, and exporting data.
Author: Kriss Harris
Publisher: SAS Institute
ISBN: 195236597X
Category : Computers
Languages : en
Pages : 198
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Book Description
Create industry-compliant graphs with this practical guide for professionals Analysis of clinical trial results is easier when the data is presented in a visual form. However, clinical graphs must conform to specific guidelines in order to satisfy regulatory agency requirements. If you are a programmer working in the health care and life sciences industry and you want to create straightforward, visually appealing graphs using SAS, then this book is designed specifically for you. Written by two experienced practitioners, the book explains why certain graphs are requested, gives the necessary code to create the graphs, and shows you how to create graphs from ADaM data sets modeled on real-world CDISC pilot study data. SAS Graphics for Clinical Trials by Example demonstrates step-by-step how to create both simple and complex graphs using Graph Template Language (GTL) and statistical graphics procedures, including the SGPLOT and SGPANEL procedures. You will learn how to generate commonly used plots such as Kaplan-Meier plots and multi-cell survival plots as well as special purpose graphs such as Venn diagrams and interactive graphs. Because your graph is only as good as the aesthetic appearance of the output, you will learn how to create a custom style, change attributes, and set output options. Whether you are just learning how to produce graphs or have been working with graphs for a while, this book is a must-have resource to solve even the most challenging clinical graph problems.
