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Its pretty much a given that computer-based recordkeeping will play a part in a clinical trial.
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IRBs are not required to review stand-alone HIPAA waivers as part of their oversight of research subject protections even if their written policies and procedures indicate they will review any written documentation provided to potential study participants, the U.S. Food and Drug Administration (FDA) clarified in a recent guidance document issued Oct. 21, 2003, and published in the Nov. 7 issue of the Federal Register.
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So what should an advertisement recruiting trial subjects say? W. Parker Nolen, MBA, IRB administrator for St. Josephs Hospital in Atlanta, recommends the following:
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Light PD, Thomas CJ. Vitamin C supplementation for coronary heart disease protection in women. Altern Ther Women's Health 2004;6(1):1-5.
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Health care practitioners now have had a couple years of experience in doing failure mode and effect analysis (FMEA) projects. Now that weve got some know-how in how to do a FMEA, it is clear that these projects arent easy.
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Throughout a recent Joint Commission survey at Paradise Valley Hospital in National City, CA, surveyors zeroed in on two key areas: staff knowledge and patient care, reports Catherine M. Fay, RN, director of performance improvement.
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To share or not to share? Thats the question for many organizations currently in the thick of the decision-making process for whether to send in the results of their periodic performance review (PPR) to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).
