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The Center for Stem Cell and Regenerative Medicine (CSCRM) is a medical research institution specializing in stem cell and other cell therapy research and treatments, located in Cleveland, Ohio. They specialize in basic and clinical research programs, biomedical and tissue engineering programs, and the development and administration of new ...
The Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) was a program sponsored by National Institutes of Health (NIH) in the United States. [1] [2] Started in 1989, CPCRA was instrumental in some research databases being established. Research from the programs assisted the evaluation of therapies for treating HIV in diverse ...
The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that deals with ethical oversights in clinical research conducted by the department, mostly through the National Institutes of Health (NIH).
The NIH Clinical Center is a hospital solely dedicated to clinical research at the National Institutes of Health campus in Bethesda, Maryland. The Clinical Center, known as Building 10, consists of the original part of the hospital, the Warren Grant Magnuson Clinical Center, and the newest addition, the Mark O. Hatfield Clinical Research Center ...
A code-break procedure is a set of rules which determine when planned unblinding should occur in a blinded experiment. FDA guidelines recommend that sponsors of blinded trials include a code-break procedure in their standard operating procedure .
The registry traces back to the Health Omnibus Programs Extension Act of 1988 (HOPE or Public Law 100-607) which mandated the development of a database of AIDS Clinical Trials Information System. It would later be expanded under the Food and Drug Administration Modernization Act of 1997 (FDAMA or Public Act 105-115 ).
The National Institute of Nursing Research (NINR), as part of the U.S. National Institutes of Health, supports clinical and basic research to establish a scientific basis for the nursing care of individuals across the life span—from management of patients during illness and recovery, to the reduction of risks for disease and disability, and the promotion of healthy lifestyles.
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
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