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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.
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 standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out routine operations. [1] SOPs aim to achieve efficiency, quality output, and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations.
The American Board of Applied Toxicology (ABAT) was established in 1985 as a standing committee by the American Academy of Clinical Toxicology.The board functions to recognize and credential clinical toxicologists who have demonstrated competence in the management of toxicity related to poisoning, overdose, chemical exposure, envenomation, or environmental exposures. [1]
The Medical Scientist Training Programs (MSTPs) are dual-degree training programs that streamline the education towards both clinical (typically MD) and research doctoral degrees. [1] MSTPs are offered by some United States medical schools, who are awarded financial support from the National Institute of General Medical Sciences , a branch of ...
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 act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and the applicable regulatory requirement(s). (ICH E6) Multicenter study. A clinical trial that is carried out at more than one medical institution. (NCI)
The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that deals with ethical oversights in clinical research conducted by the department, mostly through the National Institutes of Health (NIH).
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