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Clinical Research Associate
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. Depending on the jurisdiction, different education and certification requirements may be necessary to practice as a clinical research associate. The main tasks of the CRA are defined by good clinical practice guidelines for monitoring clinical trials, such as those elaborated by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. A CRA would subsequently grow into a Feasibility Leader, Study Start up Leader, Project Manager, and Project Director at a Pharmaceutical company or a contract research organization. A CRA is usually required to possess an academic degree in Life Sciences and n ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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Profession
A profession is a field of Work (human activity), work that has been successfully ''professionalized''. It can be defined as a disciplined group of individuals, ''Professional, professionals'', who adhere to ethical standards and who hold themselves out as, and are accepted by the public as possessing special knowledge and skills in a widely recognised body of learning derived from research, education and training at a high level, and who are prepared to apply this knowledge and exercise these skills in the interest of others. Professional occupations are founded upon specialized educational training, the purpose of which is to supply disinterested objective counsel and service to others, for a direct and definite compensation, wholly apart from expectation of other business gain. Medieval and early modern tradition recognized only three professions: Divinity (academic discipline), divinity, medicine, and law,Perks, R.W.(1993): ''Accounting and Society''. Chapman & Hall (Lond ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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Case Report Form
A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events. The sponsor of the clinical trial develops the CRF to collect the specific data they need in order to test their hypotheses or answer their research questions. The size of a CRF can range from a handwritten one-time 'snapshot' of a patient's physical condition to hundreds of pages of electronically captured data obtained over a period of weeks or months. (It can also include required check-up visits months after the patient's treatment has stopped.) The sponsor is responsible for designing a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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National Commission For Certifying Agencies
The Institute for Credentialing Excellence (ICE) is one of the two main U.S. organizations that accredit personnel certifications or certificates. In November 2009 the ICE formally changed its name from the National Organization for Competency Assurance (NOCA). The ICE is an accredited standards developer by the American National Standards Institute. History In cooperation with the federal government, the National Commission for Health Certifying Agencies (NCHCA) was founded in 1977 in order to develop standards for voluntary certification programs. In 1989, the NCHCA was expanded to developing certifications for all professions, becoming the National Commission for Certifying Agencies (NCCA), and forming the National Organization for Competency Assurance (NOCA) as a membership association for credentialing bodies. In 2009, the Board moved to change to a new name and became the Institute for Credentialing Excellence (ICE). National Commission for Certifying Agencies The Nat ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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Adverse Drug Reaction
An adverse drug reaction (ADR) is a harmful, unintended result caused by taking medication. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs. The meaning of this term differs from the term "side effect" because side effects can be beneficial as well as detrimental. The study of ADRs is the concern of the field known as ''pharmacovigilance''. An adverse drug event (ADE) refers to any unexpected and inappropriate occurrence at the time a drug is used, whether or not associated with the administration of the drug. An ADR is a special type of ADE in which a causative relationship can be shown. ADRs are only one type of medication-related harm, as harm can also be caused by omitting to take indicated medications. Classification ADRs may be classified by e.g. cause and severity. Cause *Type A: Augmented pharmacologic effects - dose dependent and predictable :Type A reactions, which constitute approximatel ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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CNNMoney
CNN Business (formerly CNN Money) is a financial news and information website, operated by CNN. The website was originally formed as a joint venture between CNN.com and Time Warner's '' Fortune'' and ''Money'' magazines. Since the spin-off of Time Warner's publishing assets as Time Inc. (and their subsequent sale to Meredith Corporation and later, to IAC's Dotdash), the site has since operated as an affiliate of CNN. History CNN Money launched in 2001, replacing CNNfn's website. Time Warner had also announced an intention to relaunch the CNNfn television network under the CNN Money moniker, but those plans were apparently scrapped. Prior to June 2014, the website was operated as a joint venture between CNN and two Time Warner-published business magazines; '' Fortune'' and ''Money''. In June 2014, Time Warner's publishing assets were spun-out as Time Inc.; as a result, all three properties launched separate web presences, and CNN Money introduced a new logo that removed the ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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Title 21 Of The Code Of Federal Regulations Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). It is divided into three chapters: * Chapter I — Food and Drug Administration * Chapter II — Drug Enforcement Administration The Drug Enforcement Administration (DEA; ) is a Federal law enforcement in the United States, United States federal law enforcement agency under the U.S. Department of Justice tasked with combating drug trafficking and distribution within th ... * Chapter III — Office of National Drug Control Policy Chapter I Most of the Chapter I regulations are based on the Federal Food, Drug, and Cosmetic Act. Notable sections: * Title 21 CFR Part 11, 11 — electronic records and electronic signature related * 50 Protection of human subjects in clinical |