Glossary
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Question: (Last edited: Friday, 31 July 2020, 6:32 PM)Common Rule | |||
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Answer: The U.S. Department of Health and Human Services regulations (45 CFR 46) for protecting human subjects, which has been adopted by 17 federal agencies. The Common Rule includes subparts with additional protections for children, neonates, pregnant women and fetuses, and prisoners. | |||
Question: (Last edited: Friday, 31 July 2020, 6:31 PM)Common law | |||
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Answer: | |||
Question: (Last edited: Friday, 31 July 2020, 6:31 PM)Commercialization | |||
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Answer: the process of developing and marketing commercial products (e.g. drugs, medical devices, or other technologies) from research. See also Copyrights, Intellectual Property, Patents. | |||
Question: (Last edited: Friday, 31 July 2020, 6:30 PM)Collaboration agreement | |||
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Answer: an agreement between two or more collaborating research groups concerning the conduct of research. The agreement may address the roles and responsibilities of the scientists, access to data, authorship, and intellectual property. | |||
Question: (Last edited: Friday, 31 July 2020, 6:29 PM)Coercion | |||
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Answer: using force, threats, or intimidation to make a person comply with a demand. | |||
Question: (Last edited: Friday, 31 July 2020, 6:29 PM)Clinical utility | |||
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Answer: the clinical usefulness of information, e.g. for making decisions concerning diagnosis, prevention, or treatment. | |||
Question: (Last edited: Friday, 31 July 2020, 6:28 PM)Clinical trial, registration | |||
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Answer: providing information about a clinical trial in a public registry. Most journals and funding agencies require that clinical trials be registered. Registration information includes the name of the trial, the sponsor, study design and methods, population, inclusion/exclusion criteria, and outcome measures. | |||
Question: (Last edited: Friday, 31 July 2020, 6:26 PM)Clinical trial, phases | |||
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Answer: sequential stages of clinical testing, required by regulatory agencies, used in the development of medical treatments. Pre-clinical testing involves experiments on animals or cells to estimate safety and potential efficacy. Phase I trials are small studies (50-100 subjects) conducted in human beings for the first time to assess safety, pharmacology, or dosing. Phase I studies are usually conducted on healthy volunteers though some are conducted on patients with terminal diseases, such as cancer patients. Phase II trials are larger studies (500 or more subjects) conducted on patients with a disease to assess safety and efficacy and establish a therapeutic dose. Phase III trials are large studies (up to several thousand subjects) conducted on patients to obtain more information on safety and efficacy. Phase IV (or post-marketing) studies are conducted after a treatment has been approved for marketing to gather more information on safety and efficacy and to expand the range of the population being treated. | |||
Question: (Last edited: Friday, 31 July 2020, 6:26 PM)Clinical trial, placebo controlled | |||
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Answer: a clinical trial in which the control group receives a placebo. The goal of the trial is to compare a treatment to a placebo. | |||