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| Referes to Code of Federal Regulations |
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| Defined by MDR's definition as any action other than routine maintenance or servicing of a device where such action is necessary to prevent recurrance of a reportable event. |
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| Civil court action to confiscate food, drugs, devices or cosmetics and remove them from the market |
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| maximum time a device will remain functional from the date of manufacture until it is used in patient care, see expiration date. |
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| A company, organization, or institution that takes responsibility for initiating, managing or financing a clinical trial. |
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| A participant in a clinical trial. May be a healthy volunteer or a patient |
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| 21 CFR 314.500: Approval based on a surrogate endpoint or a product approved with restriction and/or requirements for phase IV trials. |
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| NDA submission for changes to an approved NDA, including SUPAC |
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| PMA submission for changes to an approved device that affect safety or effectiveness. |
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| Indirect measure of outcome that is easier to measure and relates to outcome of interest |
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| Fees used by FDA to expedite review time. The fee schedule for different types of applications is published in the Federal Register Initially established by PDUFA (1992). |
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| An individual who participates in a clinical trial, either as a recipient of the investigational product or as a control |
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| subject identification code |
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| A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and to be used in lieu of the subject's name when the investigator reports adverse events or other trial-related data. |
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| A measurement of a drug's biological activity that substitutes for a clinical endpoint such as death or or pain relief. |
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| A statisitical test used to compare the means of two groups of test data |
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| aka Clinical research coordinator, person who handles most of the administrative responsibilities of a clinical trial. Acts as a liaison between the investigative site and the sponsor |
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| the location where trial related activities are actually conducted |
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| A study in which knowledge of the treatment is concealed from the people who organize and analyze the data as well as the invesitgators and subjects |
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| Error made when a null hypothesis is rejected but is actually true. Also called false positive. |
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| error mede when an alternative hypothesis is rejected but is actually true, aka false negative |
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| Some statisticians use this designation for an error made when calling the less effective treatment the more effective one. |
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| A technique used to allocate subjects into groups at a differential rate; for example, three subjects may be assigned to the treatment group for every one assigned to the control group. |
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| unexpected adverse drug reaction |
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Definition
| An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. invesitgators brochure or package insert) |
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| uniform resource letter (URL) |
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| Procedure carried out to ensure that the data contained in the clinical trial report match original observations. |
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| The accuracy of the relationship between two or more variables |
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| A measure of the variability in a sample or population. It is measured as the mean squared deviation of the individual values from their common mean. |
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| Individuals whose willingness to participate in a clinical trial may have been unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of a retaliatory response from senior members of hierarchy in case of refusal to participate |
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| A written communication from the FDA notifying an individual or firm that the agency considers one or more products, practices, processes or other activities to be in violation of the Federal FD&C Act, or other acts and that failure of the responsible party to take appropriate and prompt action to correct and prevent any future repeat of the violation may result in administrative and/or regulatory enforcement action without further notice |
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| A period in a clinical study during which subjects receive no treatment for the indication under study and the effects of a previous treatment are eliminated (or assumed to be eliminated) |
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| computer program that interprets HTML and other internet languages and protocols and displays web pages on your computer monitor |
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| a single page on a web site, such as a home page |
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| A computer program that delivers HTML pages or files |
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| A collection of web pages and other files. A site can consist of a single web page, thousands of pages, or custom created pages that draw on a database associated with the site |
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| an adjusment in a value on the basis of a judgement by the investigator |
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| The physical and mental integrity of the subjects participating in a trial |
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| within-subject difference |
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| In a cross-over trial, variability in each patient is used to assess treatment differences |
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| All resources and users on the internet that are using HTTP protocols |
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