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Clinical Investigator
A clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. The Clinical Investigator must also meet requirements set forth by the FDA, EMA or other regulatory body. The qualifications must be outlined in a current resume and readily available for auditors. See also * Clinical site * International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) * Drug development * Data monitoring committees * Food and Drug Administration (FDA) * European Medicines Agency (EMA) * European Forum for Good Clinical Practice (EFGCP) * American Society for Clinical Investigation The American Society for Clinical Investigation (ASCI), established i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, pharmaceutical drug, drugs, medical nutrition therapy, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received institutional review board, health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small Pilot experiment, pi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009. The European Medicines Agency does not call itself EMA either – it has no official acronym but may reconsider if EMA becomes commonly accepted (secommunication on new visual identity an). The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies. The hope was that this plan would ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Site
Clinical may refer to: Healthcare * Of or about a clinic, a healthcare facility * Of or about the practice of medicine Other uses * ''Clinical'' (film), a 2017 American horror thriller See also * * * Clinical chemistry, the analysis of bodily fluids for diagnostic and therapeutic purposes * Clinical death, the cessation of blood circulation and breathing * Clinical formulation, a theoretically-based explanation of information obtained from clinical assessment * Clinical governance, a systematic approach to maintaining and improving the quality of patient care * Clinical linguistics, linguistics applied to speech-language pathology * Clinical psychology, the understanding, preventing, and relieving psychologically-based distress or dysfunction * Clinical research, to determine the safety and effectiveness of medications etc. * Clinical significance, the practical importance of a treatment effect * Clinical trial, experiments or observations done in clinical research * Clinical w ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical guidelines and requirements for pharmaceutical product registration. Harmonisation leads to a more rational use of human, animal and other resources, the elimination of unnecessary delay in the global development, and availability of new medicines while maintaining safeguards on quality, safety, efficacy, and regulatory obligations to protect public health. Junod notes in her 2005 treatise on clinical drug trials that " ove all, the ICH has succeeded in aligning clinical trial requirements." History In the 1980s, the European Union began harmonising regulatory requir ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Drug Development
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug. The entire process—from concept through preclinical testing in the laboratory to clinical trial development, including Phase I–III trials—to approved vaccine or drug typically takes more than a decade. New chemical entity development Broadly, the process of drug development can be divided into preclinical and clinical work. Pre-clinical New chemical entities (NCEs, also known as new molecular entities or NMEs) are compounds that emerge from the process of drug discovery. These h ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Data Monitoring Committees
A data monitoring committee (DMC) – sometimes called a data and safety monitoring board (DSMB) – is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing. Need for a DMC Many randomized clinical trials are double-blind – no one involved with the trial knows what treatment is to be given to each trial participant. Blinding includes the participant, their doctor, and even the study personnel at the company or organization sponsoring the trial. Blinding is breached and true assignments disclosed only after the trial database is finalized and locked against edits (i.e., until it is read-only for statistical analysis). On rare occasions a single participant's treating physician may be unblinded to the participant's study treatment assignment if that information is critical to the participant's immediate health care. Clinical trials may test an unknown procedure or may continue for years, and there is justifiable ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Forum For Good Clinical Practice
The European Forum for Good Clinical Practices (EFGCP) is a European think tank which works on the ethical, regulatory, and scientific framework of clinical research in Europe. The EFGCP is committed to the development of the standards for the protection of human subjects and data quality in clinical trials, both in Europe and abroad. See also * European Clinical Research Infrastructures Network (ECRIN) * European Medicines Agency (EMEA, EU) * European and Developing Countries Clinical Trials Partnership (EDCTP) * EUDRANET * EudraVigilance * Good Clinical Practice (GCP) * Harmonization in clinical trials * International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) * Inverse benefit law * Quality assurance * Standing operating procedure A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out routine operations. SOPs aim to achieve efficiency, q ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
American Society For Clinical Investigation
The American Society for Clinical Investigation (ASCI), established in 1908, is one of the oldest and most respected medical honor societies in the United States. Organization and purpose The ASCI is an honorary society to which more than 2,800 physician-scientists from all medical specialties belong. Prospective members are proposed by standing members of the society and elected to ASCI on the basis of an outstanding record of scholarly achievement in biomedical research. The ASCI includes physician-scientists who are active clinically, in basic research, or in teaching. Many of its senior members are widely recognized leaders in academic medicine. As of 2015 the membership of ASCI has included 417 members of the National Academy of Medicine, 191 members of the National Academies of Sciences, Engineering, and Medicine The National Academies of Sciences, Engineering, and Medicine (NASEM), also known as the National Academies, is a Congressional charter, congressionally charte ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Society For Clinical Investigation
The European Society for Clinical Investigation (ESCI) was founded on February 12, 1967 as a pan-European society of clinicians and scientists. The Society covers all the topics of biomedical sciences and aims to create a common platform for researchers in fundamental sciences (e.g., genetics, biochemistry, physiology...) and applied clinical medicine (e.g., oncology, cardiology, neurology...) More recently, the Society has embraced a cross-sectional and future-oriented vision, including topics like bioinformatics, digital health, personalized medicine and gender medicine. The term ''clinical investigation'' should be therefore interpreted widely, including the whole biomedical research from bench-to-bedside and vice versa. Objectives The main objective of ESCI is to lead clinical and translational research across Europe. The Society pursues this objective through the follwoing actions: *the creation of a common language between fundamental and applied sciences, *the promotion of sc ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Research
Clinical research is a branch of medical research that involves people and aims to determine the effectiveness (efficacy) and safety of medications, devices, diagnostic products, and treatment regimens intended for improving human health. These research procedures are designed for the prevention, treatment, diagnosis or understanding of disease symptoms. 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. Description The term "clinical research" refers to the entire process of studying and writing about a drug, a medical device or a form of treatment, which includes conducting interventional studies (clinical trials) or observational studies on human participants. Clinical research can cover any medical method or product from it ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
