|
Glossary Of Clinical Research
A glossary of terms used in clinical research. __NOTOC__ A ; Activities of daily living : The tasks of everyday life. These activities include eating, dressing, getting into or out of a bed or chair, taking a bath or shower, and using the toilet. Instrumental activities of daily living are activities related to independent living and include preparing meals, managing money, shopping, doing housework, and using a telephone. Also called ADL. (NCI) ; Adverse drug reaction : In the preapproval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established, all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase "responses to a medicinal product" means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out. Regarding marketed medicinal ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Glossary
A glossary (from grc, γλῶσσα, ''glossa''; language, speech, wording) also known as a vocabulary or clavis, is an alphabetical list of Term (language), terms in a particular domain of knowledge with the definitions for those terms. Traditionally, a glossary appears at the end of a book and includes terms within that book that are either newly introduced, uncommon, or specialized. While glossaries are most commonly associated with non-fiction books, in some cases, fiction novels may come with a glossary for unfamiliar terms. A bilingual glossary is a list of terms in one language defined in a second language or Gloss (annotation), glossed by synonyms (or at least near-synonyms) in another language. In a general sense, a glossary contains explanations of concepts relevant to a certain field of study or action. In this sense, the term is related to the notion of ontology. Automatic methods have been also provided that transform a glossary into an ontology or a computational ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Best Practice
A best practice is a method or technique that has been generally accepted as superior to other known alternatives because it often produces results that are superior to those achieved by other means or because it has become a standard way of doing things, e.g., a standard way of complying with legal or ethical requirements. Best practices are used to maintain quality as an alternative to mandatory legislated standards and can be based on self-assessment or benchmarking. Best practice is a feature of accredited management standards such as ISO 9000 and ISO 14001. Some consulting firms specialize in the area of best practice and offer ready-made templates to standardize business process documentation. Sometimes a best practice is not applicable or is inappropriate for a particular organization's needs. A key strategic talent required when applying best practice to organizations is the ability to balance the unique qualities of an organization with the practices that it has in common ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Case Series
A case series (also known as a clinical series) is a type of medical research study that tracks subjects with a known exposure, such as patients who have received a similar treatment, or examines their medical records for exposure and outcome. Case series may be ''consecutive'' or ''non-consecutive'', depending on whether all cases presenting to the reporting authors over a period were included, or only a selection. When information on ''more than three patients'' is included, the case series is considered to be a systematic investigation designed to contribute to generalizable knowledge (i.e., ''research''), and therefore submission is required to an institutional review board (IRB). Case series usually contain demographic information about the patient(s), for example, age, gender, ethnic origin. etc. Case series have a descriptive study design; unlike studies that employ an analytic design (e.g. cohort studies, case-control studies or randomized controlled trials), case series ... [...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] |
Case Report
In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence. Some case reports also contain a literature review of other reported cases. Case reports are professional narratives that provide feedback on clinical practice guidelines and offer a framework for early signals of effectiveness, adverse events, and cost. They can be shared for medical, scientific, or educational purposes. Types Most case reports are on one of six topics: * An unexpected association between diseases or symptoms. * An unexpected event in the course of observing or treating a patient. * Findings that shed new light on the possible pathogenesis of a disease or an adverse effect. * Unique or rare features of a disease. * Unique therapeutic approaches. * A positional or quantitative variation of the anatomical structures. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Blinded Study
In a blind or blinded experiment, information which may influence the participants of the experiment is withheld until after the experiment is complete. Good blinding can reduce or eliminate experimental biases that arise from a participants' expectations, observer's effect on the participants, observer bias, confirmation bias, and other sources. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. In some cases, while blinding would be useful, it is impossible or unethical. For example, it is not possible to blind a patient to their treatment in a physical therapy intervention. A good clinical protocol ensures that blinding is as effective as possible within ethical and practical constraints. During the course of an experiment, a participant becomes unblinded if they deduce or otherwise obtain information that has been masked to them. For example, a patient who experiences a side effect may correc ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Double-blind
In a blind or blinded experiment, information which may influence the participants of the experiment is withheld until after the experiment is complete. Good blinding can reduce or eliminate experimental biases that arise from a participants' expectations, observer's effect on the participants, observer bias, confirmation bias, and other sources. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. In some cases, while blinding would be useful, it is impossible or unethical. For example, it is not possible to blind a patient to their treatment in a physical therapy intervention. A good clinical protocol ensures that blinding is as effective as possible within ethical and practical constraints. During the course of an experiment, a participant becomes unblinded if they deduce or otherwise obtain information that has been masked to them. For example, a patient who experiences a side effect may correc ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biostatistics
Biostatistics (also known as biometry) are the development and application of statistical methods to a wide range of topics in biology. It encompasses the design of biological experiments, the collection and analysis of data from those experiments and the interpretation of the results. History Biostatistics and genetics Biostatistical modeling forms an important part of numerous modern biological theories. Genetics studies, since its beginning, used statistical concepts to understand observed experimental results. Some genetics scientists even contributed with statistical advances with the development of methods and tools. Gregor Mendel started the genetics studies investigating genetics segregation patterns in families of peas and used statistics to explain the collected data. In the early 1900s, after the rediscovery of Mendel's Mendelian inheritance work, there were gaps in understanding between genetics and evolutionary Darwinism. Francis Galton tried to expand Mendel's ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biometry
Biostatistics (also known as biometry) are the development and application of statistical methods to a wide range of topics in biology. It encompasses the design of biological experiments, the collection and analysis of data from those experiments and the interpretation of the results. History Biostatistics and genetics Biostatistical modeling forms an important part of numerous modern biological theories. Genetics studies, since its beginning, used statistical concepts to understand observed experimental results. Some genetics scientists even contributed with statistical advances with the development of methods and tools. Gregor Mendel started the genetics studies investigating genetics segregation patterns in families of peas and used statistics to explain the collected data. In the early 1900s, after the rediscovery of Mendel's Mendelian inheritance work, there were gaps in understanding between genetics and evolutionary Darwinism. Francis Galton tried to expand Mendel' ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biometrics
Biometrics are body measurements and calculations related to human characteristics. Biometric authentication (or realistic authentication) is used in computer science as a form of identification and access control. It is also used to identify individuals in groups that are under surveillance. Biometric identifiers are the distinctive, measurable characteristics used to label and describe individuals. Biometric identifiers are often categorized as physiological characteristics which are related to the shape of the body. Examples include, but are not limited to fingerprint, palm veins, face recognition, DNA, palm print, hand geometry, iris recognition, retina, odor/scent, voice, shape of ears and gait. Behavioral characteristics are related to the pattern of behavior of a person, including but not limited to mouse movement, typing rhythm, gait, signature, behavioral profiling, and credentials. Some researchers have coined the term behaviometrics to describe the latter class ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biological Drug
A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine. Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. Some regulatory agencies use the terms ''biological medi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
