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| interactions in cyberspace with other people, information and computers. |
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| interim clinical trial/study report |
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Definition
| A report of intermediate results and their evaluation based on analyses performed during the course of a trial |
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| a property of data that does not contradict itself |
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| a property of data that does not contradict itself |
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| A global system of computer networks that provides the infrastructure for email, the World Wide Web and other online activities. |
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| Internet Service Provider |
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| A company that provides access to the internet for individuals and organizations. |
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| A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a market authorization when used or assembled in a way different from the approved form, or when used to gain further information about an approved use. |
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| A person responsible for the conduct of a clinical trial at a trial site. |
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| If a trial is conducted by a team of individuals at a trial site the responsible leader of the team is called the ___________________. |
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| A term used by ICH guidelines to indicate "the investigator and/or institution, where required by the applicable regulatory requirements." |
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| A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects |
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| legally acceptable representative |
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Definition
| An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in a clinical trial. |
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| Investigation in which data are collected from a number of subjects over a long period of time. |
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| A type of parallel trial design in which investigators identify pairs of subjects who are "identical" with respect to relevant factors, then randomize them so that one receives Treatment A and the other Treatment B. |
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| The sum of values of all observations or data points divided by the number of observations, an arithmetical average. |
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| The middle value in a data set when they are arranged in order of magnitude. |
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Term
| medical practice computer system |
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Definition
| A PC- or network based computer system used to manage electronic patient files. Defined by the European Forum for GCP. Such a system is neither sponsor-supplied nor trial-specific |
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| Medicines Control Agency (MCA) |
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Definition
| The United Kingdom regulatory authority that approves or rejects CTX/CTC and PL applications. |
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| Massive randomized clinical trials that test the advantages of marginally effective experimental drugs by enrolling 10,000 or more subjects. |
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| Memorandum of Understanding (MOU) |
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Definition
| An agreement between FDA and a regulatory agency in another country allows mutual recognition of inspections. |
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| A statistical process for pooling data from many clinical trials and summarizing it through formal statistical means. syn. overview |
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| The sum of the processes by which a substance is handled in the living body. |
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| the most frequently occuring value in a data set |
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| a device that converts the digital data in a computer into analog data that can travel on telephone lines |
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| a person employed by the sponsor or CRO who is responsible for ensuring that a trial is being conducted in accordance with the protocol. |
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| the act of overseeing a clinical trial and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, SOPs, GCPs and applicable regulatory requirements |
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| same as independent data monitoring committee |
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| A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor's SOPs |
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Definition
| A clinical trial conducted according to a single protocol, but at more than one site and therefore, carried out by more than one investigator. |
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| A trial in an individual subject is administered a treatment repeatedly over a number of episodes to establish the treatment's effect in that person, often with experimental and control treatments randomized. |
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| An application to FDA for license to market a new drug in the United States. |
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| Biomedical studies not performed on human subjects |
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| An official communication from FDA to inform an NDA sponsor that the important deficiencies described therein preclude approval unless corrected. |
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Definition
| A private institution charged by the Competent Authority with verifying compliance with the applicable Essential Requirements stated in the Medical Device Directive. This process, called Conformity Assessment, has EU-wide validity once completed by the NB. |
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| Used to rule out every possibility except the one the researcher is trying to prove, an assumption about a research population that may or may not be rejected as a result of testing. |
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| Code of ethics for conducting human medical research set forth in 1947. |
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| A measurement that cannot be influenced by investigator bias |
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| A trial in which subjects and investigators know which product each subject is receiving; opposite of double-blind study. |
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| The judgement and/or the advice provided by an independent ethics committee. |
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| The lowest level of significance at which a given null hypothesis can be rejected; that is, the probability of observing a result as extreme or more extreme than that observed if the null hypothesis is true. |
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| A method by which subjects are selected so that two subjects with similar characteristics are assigned to a set, but one receives Treatment A and nthe other receives Treatment B. |
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| Volunteers are randomized to one of two differing treatment groups (usually medicine and placebo) and usually receive the assigned treatment during the trial. Also called parallel group trial, parallel design |
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| Any component of a drug product other thant the active ingredient, such as excipients, vehicle and binders |
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Definition
| includes most submissions under an active IND, such as new protocols, final study reports, safety reports, CMC information, etc. The initial IND is 000, and each subsequent serial amendment receives the next consecutive number. |
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Definition
| Objective intent of persons legally responsible for labelling a medical product |
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| An invesitgator submits a protocol and IND rather than the manufacturer. A letter of authorization allows FDA to review the sponsor's DMF. The investigator, not the manufacturer is responsible for maintaining the IND. |
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Definition
| Any display of written, printed or graphic matter on the immediate container or package of, or affixed to, any article. |
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| Any firm that manufactures, repacks or distributes a drug product |
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| All written, printed or graphic matter accompanying an article at any time while such aritcle is in interstate commerce. Includes user manuals, brochures, advertising, etc. |
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Definition
| Firm-initiated removal or correction of a device, drug or biologic involving a minor violation of the FD&C Act not subject to legal action by the FDA. |
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| FDA program for voluntary and mandatory reporting of AEs and product problems. Use FDA form 3500 or 3500A. |
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