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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.
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.
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 ).
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:
The University of Texas Southwestern Medical Center (UT Southwestern or UTSW) is a public academic health science center in Dallas, Texas.With approximately 23,000 employees, [3] more than 3,000 full-time faculty, and nearly 4 million outpatient visits per year, UT Southwestern is the largest medical school in the University of Texas System and the State of Texas.
Developed from a 1968 a certificate program that was offered by the Harris County Hospital District, now the Harris Health System, in 1983, it became a Master of Science degree program under the auspices of Baylor. This program ranks 2nd in the nation among training programs in nurse anesthesia according to U.S. News & World Report. [20]
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The term "clinical research" refers to the entire process of studying and writing about a drug, a medical device or a form of treatment, which includes conducting interventional studies (clinical trials) or observational studies on human participants.
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