A clinical investigator involved in a
clinical trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...
is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. The Clinical Investigator must also meet requirements set forth by the
FDA
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
,
EMA
Ema or EMA may refer to:
Biology and medicine
* Anti-Endomysial Antibodies test
* Epithelial membrane antigen
* European Medicines Agency, a European Union agency for the evaluation of medicinal products
* European Medical Association, associa ...
or other regulatory body. The qualifications must be outlined in a current resume and readily available for auditors.
See also
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Clinical site
Clinical may refer to: Healthcare
* Of or about a clinic, a healthcare facility
* Of or about the practice of medicine Other uses
* ''Clinical'' (film), a 2017 American horror thriller
See also
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*
* Clinical chemistry, the analysis of bodily fl ...
*
(ICH)
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Drug development
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regu ...
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Data monitoring committees
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Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
(FDA)
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European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...
(EMA)
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European Forum for Good Clinical Practice (EFGCP)
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American Society for Clinical Investigation
The American Society for Clinical Investigation (ASCI), established in 1908, is one of the oldest and most respected medical honor societies in the United States.
Organization and purpose
The ASCI is an honorary society to which more than 2,800 p ...
(ASCI)
*
European Society for Clinical Investigation (ESCI)
External links
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* {{webarchive , url=http://webarchive.loc.gov/all/20011116130628/http%3A//www%2Efda%2Egov/cder/about/smallbiz/CFR%2Ehtm , title=Federal Regulations for Clinical Investigators , date=2001-11-16
Clinical research
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