Clinical Data Quality Checks For Cdisc Compliance Using Sas
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Clinical Data Quality Checks For Cdisc Compliance Using Sas
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Author : Sunil Gupta
language : en
Publisher: CRC Press
Release Date : 2019-09-23
Clinical Data Quality Checks For Cdisc Compliance Using Sas written by Sunil Gupta and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-09-23 with Medical categories.
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
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Author : Sunil Gupta
language : en
Publisher: CRC Press
Release Date : 2019-09-23
Clinical Data Quality Checks For Cdisc Compliance Using Sas written by Sunil Gupta and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-09-23 with Medical categories.
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
Mastering Sas Programming For Data Warehousing
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Author : Monika Wahi
language : en
Publisher: Packt Publishing Ltd
Release Date : 2020-10-16
Mastering Sas Programming For Data Warehousing written by Monika Wahi and has been published by Packt Publishing Ltd this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-10-16 with Computers categories.
Build a strong foundation in SAS data warehousing by understanding data transformation code and policy, data stewardship and management, interconnectivity between SAS and other warehousing products, and print and web reporting Key FeaturesUnderstand how to use SAS macros for standardizing extract, transform, and load (ETL) protocolsDevelop and use data curation files for effective warehouse managementLearn how to develop and manage ETL, policies, and print and web reports that meet user needsBook Description SAS is used for various functions in the development and maintenance of data warehouses, thanks to its reputation of being able to handle ’big data’. This book will help you learn the pros and cons of storing data in SAS. As you progress, you’ll understand how to document and design extract-transform-load (ETL) protocols for SAS processes. Later, you’ll focus on how the use of SAS arrays and macros can help standardize ETL. The book will also help you examine approaches for serving up data using SAS and explore how connecting SAS to other systems can enhance the data warehouse user’s experience. By the end of this data management book, you will have a fundamental understanding of the roles SAS can play in a warehouse environment, and be able to choose wisely when designing your data warehousing processes involving SAS. What you will learnDevelop efficient ways to manage data input/output (I/O) in SASCreate and manage extract, transform, and load (ETL) code in SASStandardize ETL through macro variables, macros, and arraysIdentify data warehouse users and ensure their needs are metDesign crosswalk and other variables to serve analyst needsMaintain data curation files to improve communication and managementUse the output delivery system (ODS) for print and web reportingConnect other products to SAS to optimize storage and reportingWho this book is for This book is for data architects, managers leading data projects, and programmers or developers using SAS who want to effectively maintain a data lake, data mart, or data warehouse.
Implementing Cdisc Using Sas
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Author : Chris Holland
language : en
Publisher: SAS Institute
Release Date : 2019-05-30
Implementing Cdisc Using Sas written by Chris Holland and has been published by SAS Institute this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-05-30 with Computers categories.
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.
Risk Based Monitoring And Fraud Detection In Clinical Trials Using Jmp And Sas
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Author : Richard C. Zink
language : en
Publisher: SAS Institute
Release Date : 2014-07-01
Risk Based Monitoring And Fraud Detection In Clinical Trials Using Jmp And Sas written by Richard C. Zink and has been published by SAS Institute this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-07-01 with Computers categories.
Improve efficiency while reducing costs in clinical trials with centralized monitoring techniques using JMP and SAS. International guidelines recommend that clinical trial data should be actively reviewed or monitored; the well-being of trial participants and the validity and integrity of the final analysis results are at stake. Traditional interpretation of this guidance for pharmaceutical trials has led to extensive on-site monitoring, including 100% source data verification. On-site review is time consuming, expensive (estimated at up to a third of the cost of a clinical trial), prone to error, and limited in its ability to provide insight for data trends across time, patients, and clinical sites. In contrast, risk-based monitoring (RBM) makes use of central computerized review of clinical trial data and site metrics to determine if and when clinical sites should receive more extensive quality review or intervention. Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS presents a practical implementation of methodologies within JMP Clinical for the centralized monitoring of clinical trials. Focused on intermediate users, this book describes analyses for RBM that incorporate and extend the recommendations of TransCelerate Biopharm Inc., methods to detect potential patient-or investigator misconduct, snapshot comparisons to more easily identify new or modified data, and other novel visual and analytical techniques to enhance safety and quality reviews. Further discussion highlights recent regulatory guidance documents on risk-based approaches, addresses the requirements for CDISC data, and describes methods to supplement analyses with data captured external to the study database. Given the interactive, dynamic, and graphical nature of JMP Clinical, any individual from the clinical trial team - including clinicians, statisticians, data managers, programmers, regulatory associates, and monitors - can make use of this book and the numerous examples contained within to streamline, accelerate, and enrich their reviews of clinical trial data. The analytical methods described in Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS enable the clinical trial team to take a proactive approach to data quality and safety to streamline clinical development activities and address shortcomings while the study is ongoing. This book is part of the SAS Press
Validating Clinical Trial Data Reporting With Sas
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Author : Carol I. Matthews
language : en
Publisher: SAS Institute
Release Date : 2008
Validating Clinical Trial Data Reporting With Sas written by Carol I. Matthews and has been published by SAS Institute this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with Computers categories.
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.
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language : en
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Sas Programming In The Pharmaceutical Industry
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Author : Jack Shostak
language : en
Publisher:
Release Date : 2005
Sas Programming In The Pharmaceutical Industry written by Jack Shostak and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005 with Electronic books categories.
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.
Clinical Trial Data Analysis Using R And Sas
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Author : Ding-Geng (Din) Chen
language : en
Publisher: CRC Press
Release Date : 2017-06-01
Clinical Trial Data Analysis Using R And Sas written by Ding-Geng (Din) Chen and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-06-01 with Mathematics categories.
Review of the First Edition "The goal of this book, as stated by the authors, is to fill the knowledge gap that exists between developed statistical methods and the applications of these methods. Overall, this book achieves the goal successfully and does a nice job. I would highly recommend it ...The example-based approach is easy to follow and makes the book a very helpful desktop reference for many biostatistics methods."—Journal of Statistical Software Clinical Trial Data Analysis Using R and SAS, Second Edition provides a thorough presentation of biostatistical analyses of clinical trial data with step-by-step implementations using R and SAS. The book’s practical, detailed approach draws on the authors’ 30 years’ experience in biostatistical research and clinical development. The authors develop step-by-step analysis code using appropriate R packages and functions and SAS PROCS, which enables readers to gain an understanding of the analysis methods and R and SAS implementation so that they can use these two popular software packages to analyze their own clinical trial data. What’s New in the Second Edition Adds SAS programs along with the R programs for clinical trial data analysis. Updates all the statistical analysis with updated R packages. Includes correlated data analysis with multivariate analysis of variance. Applies R and SAS to clinical trial data from hypertension, duodenal ulcer, beta blockers, familial andenomatous polyposis, and breast cancer trials. Covers the biostatistical aspects of various clinical trials, including treatment comparisons, time-to-event endpoints, longitudinal clinical trials, and bioequivalence trials.
Sharing Clinical Research Data
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2013-06-07
Sharing Clinical Research Data written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-06-07 with Medical categories.
Pharmaceutical companies, academic researchers, and government agencies such as the Food and Drug Administration and the National Institutes of Health all possess large quantities of clinical research data. If these data were shared more widely within and across sectors, the resulting research advances derived from data pooling and analysis could improve public health, enhance patient safety, and spur drug development. Data sharing can also increase public trust in clinical trials and conclusions derived from them by lending transparency to the clinical research process. Much of this information, however, is never shared. Retention of clinical research data by investigators and within organizations may represent lost opportunities in biomedical research. Despite the potential benefits that could be accrued from pooling and analysis of shared data, barriers to data sharing faced by researchers in industry include concerns about data mining, erroneous secondary analyses of data, and unwarranted litigation, as well as a desire to protect confidential commercial information. Academic partners face significant cultural barriers to sharing data and participating in longer term collaborative efforts that stem from a desire to protect intellectual autonomy and a career advancement system built on priority of publication and citation requirements. Some barriers, like the need to protect patient privacy, pre- sent challenges for both sectors. Looking ahead, there are also a number of technical challenges to be faced in analyzing potentially large and heterogeneous datasets. This public workshop focused on strategies to facilitate sharing of clinical research data in order to advance scientific knowledge and public health. While the workshop focused on sharing of data from preplanned interventional studies of human subjects, models and projects involving sharing of other clinical data types were considered to the extent that they provided lessons learned and best practices. The workshop objectives were to examine the benefits of sharing of clinical research data from all sectors and among these sectors, including, for example: benefits to the research and development enterprise and benefits to the analysis of safety and efficacy. Sharing Clinical Research Data: Workshop Summary identifies barriers and challenges to sharing clinical research data, explores strategies to address these barriers and challenges, including identifying priority actions and "low-hanging fruit" opportunities, and discusses strategies for using these potentially large datasets to facilitate scientific and public health advances.