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Clinical research investigators and coordinators could save time and aggravation during the IRB review process if they spent some time learning how their particular IRB works and what it wants.
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When M.D. Anderson Cancer Center Orlando in Orlando, FL, experienced a steep -- 96%-- rise in people enrolled in clinical trials within a few years, leaders decided that some compliance changes were needed.
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Clinical research (CR) sites will benefit from implementing a billing compliance program, particularly when handling complex studies, an expert says.
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There has been a great deal of emphasis in the past decade on improving research ethics training, but not enough thought is put into finding the best methods for providing such training, an expert says.
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The Office for Human Research Protections has posted new frequently asked questions and answers (FAQs) online at http://www.hhs.gov/ohrp/faq.html.
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Principal investigators (PIs) and clinical trial site staff increasingly work in a high stress environment with budget and deadline pressures that raise levels of stress and burnout.
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Conflicts and problems will always arise when clinical trial investigators and coordinators interact with IRB staff and members. But these can be more easily and happily resolved if CT professionals learn how to meet their own goals without creating ill will in their communication with the IRB.
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Clinical research (CR) sites that work with hospitalized, critically-ill adults face special challenges in handling the informed consent process.
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Once thought of as shocking outliers, the continuing hepatitis outbreaks in ambulatory care settings and clinics increasingly suggest that for every cluster detected, many more infections acquired in health care are being missed due to inadequate surveillance systems and lack of public health resources to investigate individual cases.
