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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.
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)
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 .
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 score of 1 is the lowest level of complexity, and a score of 3 indicates the highest level. Score 2 is assigned when the characteristics for a particular test are intermediate between the descriptions listed for scores of 1 and 3. [5] Criteria for categorization: Knowledge; Training and experience; Reagents and materials preparation
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]
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.
The American Board of Clinical Chemistry (ABCC) is an American doctoral board certification agency for clinical chemistry, toxicological chemistry, and molecular diagnostics. It was founded in 1950 with sponsorship from the American Chemical Society (ACS), American Institute of Chemists (AIC), and the American Society of Biological Chemists . [ 1 ]
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