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| An action against an individual restricting him/her from directly or indirectly providing services to a firm with an approved or pending application drug/device product application. A debarred corporation is prohibited from submitting or assisting in the submission of any NDA or ANDA. |
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| Ethical Principles of Medical Research involving human subjects. Trials conducted under GCP generally follow these principles. |
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| FDA Authorization of shipment of drug for a specific emergency use for life-threatening or serious disease with no alternative treatment. |
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| Drugs on the Market before 1938, devices on the market before 1976. |
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| Documents published by FDA to provide interpretation of regulations |
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| Contract Research Organization |
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Definition
| A person or organization contracted by the sponsor to perform one or more of the sponsor's trial related duties and activities |
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| The group of subjects in a study that receives no treatment, the standard treatment or a placebo. |
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| A study in which a test article is compared with a treatment that has known effects. |
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| The headquarters for a multi-site trial that collects all data. |
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| coordinating investigator |
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Definition
| Person who is assigned the responsibilities of coordinating investigators at different centers participating in a multicenter trial. (ICH). |
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| A committee that a sponsor may organize to coordinate the conduct of a multi-center trial |
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| The relationship of one variable to another (not to be confused with causation). |
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| Document that outlines a person's educational and professional history |
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| data and safety monitoring board |
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Definition
| Researchers who periodically review data from blinded, placebo-controlled trials. Ideally independent of the trial they monitor. Can stop a trial if tox is observed. |
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| A collection of data, typically organized for easy search and retrieval. |
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Definition
| data stored in a computer for retrieval, processing, and/or analysis. |
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Definition
| A widely used method of data encryption using a primary vate (secret) key. Each message uses one of 72 quadrillion or more possibile encryption keys that are chosen at random. The sender and receiver must both know and use the same private key. Applies a 56-bit key to each 64-bit block of data. The US government considered the key so difficult to break that it restricted the key's export to other countries. |
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Definition
| Process by which case report forms are examined for completeness, consistency, and accuracy. |
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| Characteristics of subjects or study populations which include such information as age, sex, family history, or the disease or condition they are being treated, and other characteristics relevant to the study for which they are participating |
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Definition
| Permission to examine, analyze, verify and reproduce any records and reports that are important to evaluation of a clinical trial. |
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Definition
| In pharmaocokinetics, the processes that controls transfer of a drug from the site of measurement to its target and other tissues. |
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Definition
| All records in any form that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken. |
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Definition
| The way a particular web server is identified on the internet. |
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Definition
| The number of doses per given time period. |
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Definition
| A trial where neither the subejcts nor the invesitgators know which treatment a subject is taking. |
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Definition
| Collective term for a combination of new tags and options, style sheets, and programming that lets you create web pages in HyperText Markup Language (HTML) that are more responsive to user interaction than previous versions of HTML. |
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Definition
| The desired measure of a drug's influence on a disease condition as proved by substantial evidence from adequate and well-controlled investigations |
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Definition
| A product's ability to produce beneficial effects on the course or duration of a disease. |
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Definition
| An indicator measured in a subject or biological sample to assess the safety, efficacy, or other objective of a trial. |
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Definition
| A state in which an investigator is uncertain about which arm of a clinical trial would be therapeutically superior for a patient. An investigator who has a treatment preference, or finds out one arm of a comparative trial offers a clinically therapeutic advantage should disclose this information to subjects paritcipating in the trial. |
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Definition
| Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced |
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Definition
| Institutional review board (syn) |
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Definition
| The act or process of eliminating waste products from the body |
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Definition
| A list of crtieria, any one of which excludes a potential subject from participation in a study. |
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Definition
| Term used to describe a clinical study designed to demonstrate the efficacy of a product. |
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Definition
| The consistency of a procedure between sets of data |
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Definition
| A standard protocol for exchanging files between computers on the internet. Also commonly used to download programs and other files to your computer from other servers. |
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Definition
| Complete comprehensive description of a completed trial that describes the experimental design. It also presents and evaluates the results and statistical analyses. |
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Definition
| A set of related programs located at a network gateway server that protects a private computer network from users from other netwroks. Also the security policy that is used with the programs. |
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Definition
| The first Phase 1 study study in which the test product is administered to human beings |
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Definition
| A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of the trial subjects are protected. |
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Definition
| A European Norm (EN) that has been accepted by all Member States and Published in the Official Journal of the European Communities |
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Definition
| A clinical data interchange messaging system in which messages are structured according to a predefined format and sent from one system to another. The sending system needs to know only how to convert its data into an HL7 message; the receiving system needs to know only how to extract the data. |
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Definition
| A healthy person who agrees to participate in a clinical trial for reasons other than medical and receives no direrct health benefit from participating |
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Definition
| Consisting of different elements or of elements in different proportions. |
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Definition
| France's Regulations covering the initiation and conduct of a clinical trial. |
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Definition
| links in a document that permit you to jump immediately to another document. In most Web borwsers links are displayed as colored underlined text. |
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Definition
| A set of codes that describes the way type, graphics and other elements are displayed on a web page. |
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Definition
| A person who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject cannot read |
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Definition
| The criteria that prospective subjects must meet to be eligible for participation in a study |
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Term
independent data-monitoring committee
(IDMC) |
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Definition
| A committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data and the critical efficacy endpoints and to recommend to the sponsor whether to continue, modify or stop a trial. |
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| independent ethics committee |
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Definition
| An independent review board responsible for ensuring the safety and rights of the subjects are protected |
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Definition
| A process by which a subject confirms his or her willingness to participate in a clinical trial. |
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Definition
| The act by a regulatory agency of conducting an officical review of all records and facilities involved in a clinical trial |
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Definition
| Any public or private entity or agency or medical or dental facility where clinical trials are conducted. |
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Definition
| A trial in which each subject receives both treatments being compared, or the treatment and control. Such trials are used for patients who have a stable, usually chronic condition, during both treatment periods. |
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