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Definition
| The process by which medications reach the blood stream when administered other than intravenously, for example, through nasal membranes. |
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Definition
| An official communication from the FDA to an NDA sponsor announcing an agency decision. |
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Definition
| Basis for selecting target population for a clinical trial. Subjects must be screened to ensure that their characteristics match a list of inclusion criteria and that none of their none of their characteristics match any one of the exclusion criteria. |
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Term
| adverse drug reaction (ADR) |
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Definition
| In the pre-apporval clinical experieince 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" means that a causal relationship betwen a medicinal product and an adverse event is at least a reasonable possiblity. |
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Definition
| Any outward medical occurence in a patient or clincial investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. |
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| Step-by-step procedure for solving a mathematical problem; also used to describe step-by-step procedures for making a series of choices among alternative decisions to reach an outcome. |
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Definition
| A part that is a definite fraction of a whole. |
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Definition
| False positive; syn. Type I error |
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Definition
| A substance being analyzed; in chromatography, a single component of a mixture. |
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Definition
| A small application, typically downloaded from a server |
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Definition
| An official communication from the FDA to an NDA sponsor that lists minor issues to be resolved before an approval can be issued |
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Term
| approval (in relation to institutional review boards) |
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Definition
| The affirmation decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, good clinical practice, and the applicable regulatory requirements. |
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Definition
| An official communication from the FDA to inform an NDA sponsor of an agency decision that allows commercial marketing of the product |
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Definition
| A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's standard operating procedures, good clincial practices, and the applicable regulatory requirements. |
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Definition
| Document that certifies that an audit has taken place (at an investigative site, CRO, or clinical research department of a phamraceutical company. |
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Definition
| A written evaluation by the sponsor's auditor of the results of the audit |
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Definition
| Documentation that allows reconstruction of the course of events. |
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Definition
| Trial in which a particular type of subject is equally represented in each study group. |
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Definition
| An indicator of the throughput(speed) of data flow on a transmission path; the width of the range of frequencies on which transmission medium carries electronic signals. All digital and analog signals have a bandwidth. |
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Term
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Definition
| Assessment of subjects as they enter a trial and before they receive any treatment. |
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Term
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Definition
| Statisitcal approach named for Thomas Bayes (1701-1761) that has among its features, giving a subjective interpretation to probability, accepting the idea that that it is possible to talk about the probability of a hypotheses being true and of parameters having particular values |
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Definition
| False negative; Type II error |
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Term
| between-subject variation |
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Definition
| in a parallel trial design, differences between subjects are used to assess treatment differences |
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Definition
| Methods for quantitative measurement of a drug, drug metabolites or chemicals in biological fluids. |
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Definition
| Rate and extent to which a drug is either absorbed or is otherwise available to the treatment site in the body. |
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Definition
| Scientific basis on which generic and brand-name drugs are compared. To be considered bioequivalent, the bioavailability of two products must not differ significantly when the two products are given at the same dosage under similar conditions. |
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Definition
| Branch of statistics applied to the analysis of biological phenomenea. |
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Definition
| One in which the subject or the investigator (or both) are unaware of what trial product a subject is taking. |
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Definition
| Products that appear idential in size, shape, color, flavor, and other attributes to make it very difficult for subjects and investigators to determine which medication is being administered. |
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Definition
| A procedure in which one or more parties to the trial are kept unaware of the treatment assignments. |
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Term
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Definition
| Computer program that runs on the user's desktop and is used to navigate the world wide web. |
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Term
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Definition
| Storage area on the computer's hard drive where the browser stores (for a limited time) web pages and/or graphic elements |
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Definition
| Effects of treatment that persist after treatment has stopped, sometime beyond the time of a medication's known biological activity. |
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Term
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Definition
| A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject. |
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Term
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Definition
| Data evaluated by sorting into various categories(for example severe, moderate, and mild categories) |
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Term
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Definition
| Determining whether there is a reasonable possiblity that the drug caused or contributed to an adverse event. It includes assessing temporal relationships, dechallenge/rechallenge information, association with underlying disease, and the presence (or absence) of a more likely cause. |
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Definition
| Biological timing and rhythmicity that, in human beings, is characterized by cycles of approximately 24 hours |
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Term
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Definition
| One from which errors have been eliminated and in which measurements and other values are provided in the same units |
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Definition
| A program that makes a service request of another (the server) that fulfills the request. |
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Term
| clinical research associate |
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Definition
| Person employed by a sponsor, or by a contract research organization acting on a sponsor's behalf who monitors the progress of investigator sites participating in a clinical study. |
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Term
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Definition
| Change in a subject's clinical condition regarded as important whether or not due to the test article. Should be stated in the protocol. |
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Term
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Definition
| Systematic study of a test article in one or more human subjects intended to discover or verify clinical, pharmacological and/or pharmacodynamic effects of an investigational product, and/or to study absorption, distribution, metabolism, excretion, of an investigational product, with the object of ascertaining its safety and/or efficacy. |
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Term
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Definition
| A written description of a trial of any therapeutic, prophylactic, or diagnostic conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report. |
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Term
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Definition
| A scheme that allows sponsors to apply for approval for each clinical study in turn, submitting supporting data to the Medicines Control Agency (MCA), which approves or rejects the application. Approval means that the company is exempt from the requirement to hold a clinical trial certificate. |
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Term
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Definition
| Complete set of supplies provided to an investigator by the trial sponsor. |
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Term
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Definition
| In clinical trials, the process of assigning data to categories for analysis. |
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Term
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Definition
| Group of subjects in a clinical trial followed up at regular predetermined intervals. |
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Term
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Definition
| One in which an investigative drug is compared against another product, either active drug or placebo. |
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Term
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Definition
| An investigational or marketed product, or placebo used as reference in a clinical trial. |
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Definition
| The regulatory body charged with monitoring compliance with the national statutes and regulation of European Member States. |
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Definition
| Adherence to all the trial-related requirements, GCP requirements, and the applicable regulatory requirements. |
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Definition
| Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity. |
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Definition
| The process by which compliance with the Essential Requirements (ER) is assessed. |
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Definition
| Document used during the consent process that is the basis for explaining to potential subjects the risks and potential benefits of a study and the rights and responsibilities of the parties involved. |
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Definition
| FDA official who coordinates the review process of various applications. |
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Term
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Definition
| A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract. |
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Definition
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Definition
| Time period between filing a protocol under an IND application and FDA's okay to proceed with enrollment. |
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Definition
| Voluntary form used by health professionals, consumers and patients to submit reports regarding adverse events and product problems with FDA regulated products. |
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Definition
| Mandatory form used by user facilities, importers and manufacturers of FDA-regulated products to submit reports of adverse events and product problems with FDA-regulated products. |
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Definition
| Form to market a new drug, biologic or antibiotic drug for human use. |
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Definition
| Form for notice of inspection. |
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Term
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Definition
| Form on Inspection Report for Inspectional Observations |
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Term
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Definition
| An NDA containing one or more investigations necessary for approval that were not conducted by applicant and for which applicant has no right or reference (previously known as a "paper" NDA). |
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Definition
| A premarket notification submitted to FDA to demonstrate that the medical device to be marketed is as safe and effective or is substantially equivalent to a legally marketed device. |
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Definition
| Additions or changes to an NDA, PMA, or PMA Supplement still under review. Includes Safety Updates |
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Definition
| FDA designation given to drugs, biologics and medical devices that have approved marketing applications (NDA, BLA, or PMA). |
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Term
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Definition
| Any virus, therapeutic serum, toxin, antitoxin or analogous product applicable to the prevention, treatment or cure of disease or injuries in man. |
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Definition
| Requirements of laws and regulations enforced by the FDA. |
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Term
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Definition
| Low-risk device requiring general controls to assure safety and effectiveness. |
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Term
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Definition
| Requires general and special controls to ensure safety and efficacy. Special controls may include mandatory performance standards, patient registries for implantable devices, and postmarket surveillance. Requires 501(k) unless exempted. May require clinical trials. |
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Term
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Definition
| Requires general controls, special controls and PMA; includes devices that are life-sustaining, life supporting or pose potential risk to patients. PMA may require clinical trials. |
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Term
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Definition
| Devices that receive permission to market, not approval. Designation based on demonstrating substantial equivalence to a preamendment device or another device reviewed inder section 501(k) of the FD&C Act. |
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