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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.
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 ...
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.
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 ...
Created in 1999, the CIP program is a result of many years of discussions and planning by organizational members and leaders. It is endorsed by federal regulatory officials, professional associations, many national advisory bodies and IRB professionals who are committed to improving the quality of human research protection programs.
In 1993, the Research Administrators Certification Council (RACC) was founded as a private non-profit organization. [5] Active CRAs sit on the council and have the role of certifying that an individual possesses adequate knowledge for serving as a professional research administrator of sponsored programs, particularly federally-funded research grants and contracts.
A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.
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:
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