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Clinical trial research teams can run into regulatory trouble when there are too few checks and balances established to catch the mistakes and omissions.
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Clinical trial sites and investigators should not rely on clinical research organization (CRO) monitors to find systemic problems. Instead, they should be proactive with their own in-depth audits, an expert suggests.
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Universities in North America face risks in the way they execute research administration, an expert says.
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Compliance problems at clinical trial (CT) sites can result in FDA warning letters to sponsors for their lack of adequate follow-up after finding compliance problems, an expert says.
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The availability of group and individual counseling for hospital staff following two shootings within eight months of each other in Blacksburg, VA, was invaluable, says Mike Hill, RN, the ED director at Montgomery Regional Hospital, which treated 17 victims of the recent shootings at Virginia Tech.
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A wide-ranging group of experts convened by The Hastings Center has put forth some general understandings of quality improvement what it is, what role it plays in health care, and how ethical conduct can be ensured in QI projects. Their conclusions are reported in a new paper in the Annals of Internal Medicine.
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Despite the chaos and upheaval of the horrific tragedy that befell Virginia Tech on Monday morning, April 16, 2007, the orderly response from the medical community went pretty much according to plan.
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Whether they are called patient safety officers (as many now are), patient safety managers, or some other title, individuals whose overall responsibility at their facility or health system is minimizing errors and complying with safety standards such as The Joint Commission's National Patient Safety Goals are gaining in both prominence and responsibility.
