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The Institute of Medicine received funding from the American Recovery and Reinvestment Act of 2009 to recommend a list of top priorities for the initial focus in comparative effectiveness research (CER).
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The Patient Protection Affordable Care Act, which was signed into law in March 23, 2010, contains a Physician Payment Sunshine Provision that requires pharmaceutical and biotech companies to report all gifts and compensation made to physicians, including researchers.
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Research organizations increasingly provide guidance to investigators, assisting them with compliance and regulatory documentation, but typically they leave the Good Clinical Practice (GCP) training to sponsors and others.
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Clinical trial sponsors need to build a business plan for their subject recruitment process, and it should include strategies for building a solution and tracking results, an expert says.
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The new health care reform bill provides another big influx of federal research funding, and research organizations will need to prepare and apply as quickly as they can, experts say.
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The Philadelphia-based University of Pennsylvania's office of human research has developed research compliance tools and templates to assist investigators in adhering to Good Clinical Practice.
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Buying media advertisements to recruit subjects often is the easiest way to make a study's enrollment deadlines, but it is an expensive method if not used carefully.
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Research organizations often have trouble distinguishing between protocol deviations and violations, and the regulations are little help in making these definitions, an expert says.
