Clinical Trials Administrator Archives – December 1, 2011
December 1, 2011
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Researchers' misconceptions often prevent enrollment of minorities
The fear of rejection due to stigma sometimes stops investigators from approaching minority communities about enrolling in research studies. This is a misconception that needs to be addressed and corrected, clinical research ethical experts say. -
African Americans will enroll in CTs: just ask
A recent study involving recruitment for a nicotine dependence trial has found that African American populations are open to involvement in clinical research when asked. -
FDA's risk targeting apt to find more mistakes
The U.S. Food and Drug Administration (FDA) in recent years has shifted its focus in ways that are resulting in more warning letters and audits conducted based on risk analysis targeting. -
Examples of how to avoid regulatory snafus
Clinical trial sites sometimes make regulatory audit situations worse by failing to respond with comprehensive corrective action plans, an expert says. -
Best Practices Spotlight: Program makes case for more face-time education
All research institutions provide some ongoing education and training to staff, but these programs often are variable and dependent on which department is in charge. -
Here are quick tips on corrective action plans
Research institutions often need a quick and efficient compliance and quality improvement strategy. One strategy that can satisfy those objectives is the corrective action plan (CAP). -
Compliance Corner: Develop a model CR billing compliance system
Research institutions lose time and efficiency during the typical billing compliance process. The risk of mistakes that could trigger regulatory problems can be high when a Medicare billing process is poorly organized and checks and balances are weak.