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Investigators and physicians may be experts on research and medicine, but its up to the research compliance staff and the clinical trial managers to be experts in the interpretation and application of regulations governing clinical research.
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A fourth pathogen, Rickettsia parkeri, has been identified as a newly identified cause of rickettsial spotted fever in the United States.
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The case for this PCR assay for aspergillus DNA remains unproven; and that proof can only be obtained by undertaking a formal prospective study in which samples for the detection of galactomannan and fungal DNA by PCR are taken at several predetermined intervals eg, 2-3 times weekly from all patients at risk.
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The interaction of cell to cell negative with cell to cell positive may be the crucial consideration between real patients.
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FDA Rejects Plan B Bid; Rosuvastatin: Markets Most Potent Statin; FDA Actions
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Although progress is being made, advocates say, women still have a lot of catching up to do after decades of historical, cultural, and legal barriers that excluded them from both the benefits and risks of participation in medical research.
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In a never-ending quest to make clinical trials safe for participants and learn from unfortunate incidents that may have occurred during a clinical trial, the Food and Drug Administration is not only scrutinizing corrective and preventive action plans (CAPA), but also looking outside of health care for effective quality assurance processes.
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An expert advises how to best comply. Slipping away are the days of pen-and-paper record keeping. Here to stay are electronic records and electronic signatures.
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Petition for stem cell policy change circulated; Stem cell research moving forward; FDA initiative seeks to speed up approvals.
