Clinical Trials: Risk, Safety, and Liability

April 10, 2014 | Health System Risk Management

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Community hospitals and other healthcare settings have opportunities to participate in clinical trials through academic community networks or partnerships with federally sponsored clinical trials (e.g., National Cancer Institute's community clinical oncology program and cooperative group programs, industry-sponsored trials). Federally and privately supported clinical trials are registered and listed in a searchable database (http://ClinicalTrials.gov) as required by the Food and Drug Administration Modernization Act of 1997. The database includes the study protocol, its purpose, recruitment status, eligibility criteria, study locations, contact information, adverse event information, and in some cases, study results. Risk managers may wish to check the website periodically to determine if their facility has been listed as research site for any active studies.

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Note:

ICMJE = International Committee of Medical Journal Editors

FDAAA = Food and...

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