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The National Institutes of Health Clinical Research Training Program (CRTP) was a one-year education program aimed at highly qualified, research-oriented medical and dental students wanting to learn the theory and practice of clinical and translational research that ran from 1997 to 2012.
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]
The NIH began awarding the MSTP designation in 1964. Albert Einstein College of Medicine, Northwestern University, and New York University were the original three MSTP programs that were established. As of 2024, there were 58 NIH-funded MSTP programs in the US (56 MD-PhD, 4 DVM-PhD), supporting over 1000 students at all stages of the program ...
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 systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), good clinical practice (GCP), and the applicable ...
An independent safety officer (ISO) is a clinician or researcher who is independent of the clinical study team and helps to monitor a clinical trial for research participant (patient) safety, adverse events, trial progress, and data quality. An ISO has relevant experience with clinical trials as well as with the patient population and ...
Clinical and Translational Science Award (CTSA) is a type of U.S. federal grant administered by the National Center for Advancing Translational Sciences, part of the National Institutes of Health. The CTSA program began in October 2006 under the auspices of the National Center for Research Resources with a consortium of 12 academic health centers .
A clinical research associate (CRA), also called a clinical monitor or trial monitor, is a health-care professional who performs many activities related to medical research, particularly clinical trials. Clinical research associates work in various settings, such as pharmaceutical companies, medical research institutes and government agencies.
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