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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 needs ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Profession
A profession is a field of work that has been successfully ''professionalized''. It can be defined as a disciplined group of individuals, '' 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, medicine, and law,Perks, R.W.(1993): ''Accounting and Society''. Chapman & Hall (London); . p.2. which were called the learned professions. A profession ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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] |
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 Natio ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 approximate ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 wordma ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 * 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: * 11 — electronic records and electronic signature related * 50 Protection of human subjects in clinical trials * 54 Financial disclosure by clinical investigators * 56 Institutional review boards that oversee clinical trials * 58 Good laboratory practices (GLP) for nonclinical studies The 100 series are regulations pertaining to food: * 101, especially 101.9 — Nutrition facts label related ** (c)(2)(ii) — Requirement to ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
EudraLex
EudraLex is the collection of rules and regulations governing medicinal products in the European Union. Volumes EudraLex consists of 10 volumes: *Concerning Medicinal Products for Human use: **Volume 1 - Pharmaceutical Legislation. **Volume 2 - Notice to Applicants. ***Volume 2A deals with procedures for marketing authorisation. ***Volume 2B deals with the presentation and content of the application dossier. ***Volume 2C deals with Guidelines. **Volume 3 - Guidelines. *Concerning Medicinal Products for human use in clinical trials (investigational medicinal products). **Volume 10 - Clinical trials. *Concerning Veterinary Medicinal Products: **Volume 5 - Pharmaceutical Legislation. **Volume 6 - Notice to Applicants. **Volume 7 - Guidelines. **Volume 8 - Maximum residue limits. *Concerning Medicinal Products for Human and Veterinary use: **Volume 4 - Good Manufacturing Practices. **Volume 9 - Pharmacovigilance. *Miscellaneous: **Guidelines on Good Distribution Practice of Medicinal ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Union
The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been described as a '' sui generis'' political entity (without precedent or comparison) combining the characteristics of both a federation and a confederation. Containing 5.8per cent of the world population in 2020, the EU generated a nominal gross domestic product (GDP) of around trillion in 2021, constituting approximately 18per cent of global nominal GDP. Additionally, all EU states but Bulgaria have a very high Human Development Index according to the United Nations Development Programme. Its cornerstone, the Customs Union, paved the way to establishing an internal single market based on standardised legal framework and legislation that applies in all member states in those matters, and only those matters, where the states have agreed to act ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Research Coordinator
A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice (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 as: * Trials are conducted ethically, as defined by the Declaration of Helsinki, rigorously, as defined by the International Conference on Harmonization Guidelines (ICH). * Benefits outweigh risks for each patient. * Rights, safety and well-being of patients prevail over science. * All available non-clinical and clinical information on any investigational agent can support the trial as designed. * All trials are scientifically sound and clearly described. * All clinical trials have current Institutional Review Board approval. * Medical decisions and care are the responsibility of qualified health care professionals, specifically physicians and, if applicable, d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial Protocol
In natural and social science research, a protocol is most commonly a predefined procedural method in the design and implementation of an experiment. Protocols are written whenever it is desirable to standardize a laboratory method to ensure successful replication of results by others in the same laboratory or by other laboratories. Additionally, and by extension, protocols have the advantage of facilitating the assessment of experimental results through peer review. In addition to detailed procedures, equipment, and instruments, protocols will also contain study objectives, reasoning for experimental design, reasoning for chosen sample sizes, safety precautions, and how results were calculated and reported, including statistical analysis and any rules for predefining and documenting excluded data to avoid bias. Similarly, a protocol may refer to the procedural methods of health organizations, commercial laboratories, manufacturing plants, etc. to ensure their activities (e.g., b ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Research
Medical research (or biomedical research), also known as experimental medicine, encompasses a wide array of research, extending from "basic research" (also called ''bench science'' or ''bench research''), – involving fundamental scientific principles that may apply to a ''preclinical'' understanding – to clinical research, which involves studies of people who may be subjects in clinical trials. Within this spectrum is applied research, or translational research, conducted to expand knowledge in the field of medicine. Both clinical and preclinical research phases exist in the pharmaceutical industry's drug development pipelines, where the clinical phase is denoted by the term ''clinical trial''. However, only part of the clinical or preclinical research is oriented towards a specific pharmaceutical purpose. The need for fundamental and mechanism-based understanding, diagnostics, medical devices, and non-pharmaceutical therapies means that pharmaceutical research i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Freelancer
''Freelance'' (sometimes spelled ''free-lance'' or ''free lance''), ''freelancer'', or ''freelance worker'', are terms commonly used for a person who is self-employed and not necessarily committed to a particular employer long-term. Freelance workers are sometimes represented by a company or a temporary agency that resells freelance labor to clients; others work independently or use professional associations or websites to get work. While the term ''independent contractor'' would be used in a different register of English to designate the tax and employment classes of this type of worker, the term "freelancing" is most common in culture and creative industries, and use of this term may indicate participation therein. Fields, professions, and industries where freelancing is predominant include: music, writing, acting, computer programming, web design, graphic design, translating and illustrating, film and video production, and other forms of piece work that some cultural the ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
