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Acute Treatment is inpatient medical care, outpatient medical care and other related services for surgery, acute medical conditions, or injuries, usually for a short-term illness or condition. Short-term rehabilitative services lasting no more than sixty (60) days associated with a research related injury may be covered under this definition on a case by case basis, as determined by Risk Management. This care would not encompass long-term rehabilitative services, long term nursing home care or Long Term Acute Care (LTAC) hospitalization care.
Clinical Trial is a research study involving human subjects that is designed to seek basic biological knowledge or assess the safety, efficacy or both of drugs, devices, diagnostics, treatments, or preventive measures.
Human Subject is a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
Minimal Risk is the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Research as defined in the Federal Regulations as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program, which is considered research for other purposes.
Study Related Injuries are injuries or complications arising from the performance of the study in accordance with the protocol or use of the investigational drug or device. Study related injuries do not include the normal progression of the subject’s disease, injuries or complications that would have incurred had they not participated in the clinical trial, or injuries resulting from, or caused by, negligence or willful misconduct of university study personnel.
Study Subject Insurance is a non-governmental employer or commercial sponsored health plan, policy or program to pay for health care costs.
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