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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 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.
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.
Clinical research is different from clinical practice: in clinical practice, established treatments are used to improve the condition of a person, while in clinical research, evidence is collected under rigorous study conditions on groups of people to determine the efficacy and safety of a treatment.
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.
NAACLS is the primary accrediting body for clinical laboratory programs in the US, though the Accrediting Bureau of Health Education Schools(ABHES) also accredits a handful of programs. [1] Graduates of the ABHES are not eligible for the American Society for Clinical Pathology (ASCP) certification, but are eligible for the American Medical ...