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A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice [1] (GCP) under the auspices of a Principal Investigator (PI). Good clinical practices principles have been defined by Madelene Ottosen, RN, MSN, of The University of Texas Health Science Center at Houston [ 2 ] as:
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.
A number of one-year research training programs have arisen in the US, including the Howard Hughes Medical Institute (HHMI) Medical Fellows Program (1984–present), the HHMI-NIH Research Scholars Program (1989–present), the Doris Duke Clinical Research Fellowship Program, and the Sarnoff Cardiovascular Foundation Research Fellowship Program.
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]
Obtaining a certificate is voluntary in some fields, but in others, certification from a government-accredited agency may be legally required to perform certain jobs or tasks. Organizations in the United States involved in setting standards for certification include the American National Standards Institute (ANSI) and the Institute for ...
The IATA Operational Safety Audit (IOSA) programme is an internationally recognised and accepted evaluation system designed to assess the operational management and control systems of an airline. IOSA uses internationally recognised quality audit principles and is designed to conduct audits in a standardised and consistent manner.
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