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Data Integrity in Clinical Trials Ensuring Valid Results
Let’s face it. You’re under more pressure than ever to conduct more complex and larger trials — and to do them faster.
And the FDA is focusing in on your data integrity. Beverly Lorell, a former clinical investigator and FDA advisory panel members stated “The quality of conduct of an FDA-regulated clinical investigation is inextricably intertwined with data integrity.”
Consider these facts:
A new FDA draft guidance issued in May 2016 directs clinical trial sponsors to improve their electronic data capture systems to ensure interoperability with electronic health records used by healthcare organizations.
Over the past five years, FDA inspections of investigators in response to complaints or whistle-blowers have doubled, bringing them to almost 25 percent of the more than 1,000 inspections the agency conducts each year.
The number of clinical investigators in the U.S. is shrinking, leaving sponsors to rely on researchers and institutions in other countries that may be less experienced and poorly trained.
From 2010 to 2011, almost five percent of investigator inspections related to marketing applications led to major delays in approval, such as refusal-to-file decisions, rejection of study data and requests for additional trial activity to demonstrate the validity of the data in the application.
Data Integrity in Clinical Trials: Ensuring Valid Results details the challenges of maintaining data integrity in clinical trials and offers solutions for closing gaps that can lead to tainted results. The report will cover the following:
How inadequate training of researchers can threaten data integrity
How use of electronic patient records bumps up against privacy requirements in HIPAA
How BIMO programs monitor trials and recent inspection trends
How to prioritize remediation efforts by risk
Current trends in clinical trials that make data security more complicated — and more important — than ever
Order your copy today — prevent potential missteps and create a remediation strategy that corrects violations and protects the validity of the trail’s findings.
PDF Edition
Available Format
PDF Edition — $397
Who Will Benefit
Medical Affairs Officers
Director of Clinical Operations
Regulatory Affairs Professionals
Director of Publications
Director of Clinical Trial Regulatory Management
Clinical Trial Information Disclosure Directors
Global Clinical Safety and Pharmacovigilance Officers
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