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
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 Features Understand how to use SAS macros for standardizing extract, transform, and load (ETL) protocols Develop and use data curation files for effective warehouse management Learn how to develop and manage ETL, policies, and print and web reports that meet user needs Book DescriptionSAS 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 learn Develop efficient ways to manage data input/output (I/O) in SAS Create and manage extract, transform, and load (ETL) code in SAS Standardize ETL through macro variables, macros, and arrays Identify data warehouse users and ensure their needs are met Design crosswalk and other variables to serve analyst needs Maintain data curation files to improve communication and management Use the output delivery system (ODS) for print and web reporting Connect other products to SAS to optimize storage and reporting Who 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.
Sharpening Your Advanced Sas Skills
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Author : Sunil Gupta
language : en
Publisher: CRC Press
Release Date : 2015-10-15
Sharpening Your Advanced Sas Skills 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 2015-10-15 with Mathematics categories.
Sharpening Your Advanced SAS Skills presents sophisticated SAS programming techniques, procedures, and tools, such as Proc SQL, hash tables, and SAS Macro programming, for any industry. Drawing on his more than 20 years' experience of SAS programming in the pharmaceutical industry, the author provides a unique approach that empowers both advanced p
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.
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
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.
Dictionary Of Pharmaceutical Medicine
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Author : Gerhard Nahler
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-06-29
Dictionary Of Pharmaceutical Medicine written by Gerhard Nahler and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-06-29 with Medical categories.
This dictionary is aimed primarily at the beginners entering the new discipline of Pharmaceutical Medicine, an area comprising aspects of toxicology, pharmacology, pharmaceutics, epidemiology, statistics, drug regulatory and legal affairs, medicine and marketing. But also more experienced colleagues in departments engaged in clinical development as well as researchers and marketing experts in the pharmaceutical industry will find concise and up-to-date information. The book is completed by a list of a about 1000 abbreviations encountered in pharmaceutical medicine and a compilation of important addresses of national and international health authorities.
Registries For Evaluating Patient Outcomes
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Author : Richard E. Gliklich
language : en
Publisher:
Release Date : 2014
Registries For Evaluating Patient Outcomes written by Richard E. Gliklich and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014 with Diseases categories.
Principles Of Health Interoperability
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Author : Tim Benson
language : en
Publisher: Springer
Release Date : 2016-06-22
Principles Of Health Interoperability written by Tim Benson and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-06-22 with Medical categories.
This book provides an introduction to health interoperability and the main standards used. Health interoperability delivers health information where and when it is needed. Everybody stands to gain from safer more soundly based decisions and less duplication, delays, waste and errors. The third edition of Principles of Health Interoperability includes a new part on FHIR (Fast Health Interoperability Resources), the most important new health interoperability standard for a generation. FHIR combines the best features of HL7’s v2, v3 and CDA while leveraging the latest web standards and a tight focus on implementability. FHIR can be implemented at a fraction of the price of existing alternatives and is well suited for use in mobile phone apps, cloud communications and EHRs. The book is organised into four parts. The first part covers the principles of health interoperability, why it matters, why it is hard and why models are an important part of the solution. The second part covers clinical terminology and SNOMED CT. The third part covers the main HL7 standards: v2, v3, CDA and IHE XDS. The new fourth part covers FHIR and has been contributed by Grahame Grieve, the original FHIR chief.
Contract Research And Development Organizations Their History Selection And Utilization
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Author : Shayne C. Gad
language : en
Publisher: Springer Nature
Release Date : 2020-07-17
Contract Research And Development Organizations Their History Selection And Utilization written by Shayne C. Gad and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-07-17 with Medical categories.
This volume provides a complete update of all the materials in prior volumes on the subject (including current directories to testing labs and other support establishments worldwide), while adding substantial new material on the following topics: · The history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went. · Study directors and principal investigators. · The nuts and bolts of study performance. · Electronic reporting requirements – SEND and eCTD (required for NDA, BLA, ANDA, and IND submissions). · Consultants and their roles. · An expanded examination of common problems and their solutions. This book boasts complete directories to the global universe of operating labs – where they are, how to contact them, and what they do (including special capabilities). Additionally, checklists for qualifying labs and manufacturing facilities – and for auditing studies and projects at such facilities – are included. It is directed at those in industry (specifically directed at those working for companies using CRO services) but will also be of interest to scientists or administrators working in research organizations themselves. In this case, the contents of this new work are essential to the target reader because the work, regulations, and actors (CROs) have evolved and changed at a rapid pace in the 10 years since the earlier volume that the author published. Likewise, the companies using these services have come to all be almost completely dependent on outsourcing. The earlier texts remain the only source of their kind (paper or electronic) on the field and the only noncommercial guide to the global industry and this volume provides a complete update.