Risk-based monitoring and fraud detection in clinical trials using JMP and SAS.

Format:

Book

Author/Creator:

Zink, Richard C.

Contributor:

SAS Institute.

Language:

English

Subjects (All):

JMP (Computer file).

Pharmaceutical biotechnology industry.

Scripting languages (Computer science).

SAS (Computer program language).

Physical Description:

1 online resource (1 v.) : ill.

Edition:

1st edition

Place of Publication:

Cary, North Carolina : SAS Institute, 2014.

System Details:

text file

Summary:

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

Contents:

Introduction

Risk-based monitoring: basic concepts

Risk-based monitoring: customizing the review experience

Detecting fraud at the clinical site

Detectign patient fraud

Snapshot comparisons

Final thoughts.

Notes:

Includes bibliographical references and index.

Description based on online resource; title from title page (Safari, viewed August 6, 2014).

Description based on publisher supplied metadata and other sources.

ISBN:

9781629592329

1629592323

9781612909912

1612909914

OCLC:

887736345