Glossaries
Glossaries
| Term | Definition |
|---|---|
| approvable letter |
An official communication from FDA to an NDA/ BLA sponsor that lists issues to be resolved before an approval can be issued. [Modified from 21 CFR 314.3; Guidance to industry and FDA staff (10/08/2003)]
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| applicable regulatory requirement(s) |
Any law(s) or regulation(s) addressing the conduct of clinical trials of investigational products. [ICH E6(R2) Glossary, 1.4]
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| applet |
A small application, typically downloaded from a server.
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| anticipated adverse event |
Other adverse events that are not study endpoints and are not "expected" (i.e., because they are not in the investigator's brochure) that can be anticipated to occur with some frequency during the course of the trial, regardless of drug exposure, depending on the patient population and disease under study. NOTE: Examples of such "anticipated" events include known consequences of the underlying disease or condition under investigation, events anticipated from any background regimen, or re-emergence or worsening of a condition relative to pretreatment baseline. [after FDA, Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies]
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| anonymization |
The process of protecting privacy that removes the association between the identifying data and the data subject. In anonymized data, the patient cannot be identified by the recipient of the information. [ISO TS 25237:2008; TransCelerate Protection of Personal Data in Clinical Documents - A Model Approach]
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| anchor |
Designation for a planned activity, often marking the transition between epochs or elements of a clinical study plan (e.g., "FPFV-first patient first visit").
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| analysis variables |
Variables used to test the statistical hypotheses identified in the protocol and analysis plan; variables to be analyzed. See also variable.
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| analysis set |
A set of subjects whose data are to be included in the main analyses. This should be defined in the statistical section of the protocol. NOTE: There are a number of potential analysis sets, including, for example, the set based upon the intent-to-treat principle. [ICH E9]
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| analysis dataset |
An organized collection of data or information with a common theme arranged in rows and columns and represented as a single file; comparable to a database table. NOTE: standardizing analysis datasets is intended to make review and assessment of analysis more consistent [ADaM].
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| American National Standards Institute (ANSI) |
Founded in 1918, ANSI itself does not develop standards. ANSI's roles include serving as the coordinator for US voluntary standards efforts, acting as the approval body to recognize documents developed by other national organizations as American National Standards, acting as the US representative in international and regional standards efforts, and serving as a clearinghouse for national and international standards development information. [HL7]
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| amendment |
A written description of a change(s) to, or formal clarification of, a document.
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| alpha error |
The likelihood that a relationship observed between two variables is due to chance. The probability of a Type 1 error. [Modified from AMA Manual of Style]
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| algorithm |
Step-by-step procedures for making a series of choices among alternative decisions to reach a calculated result or decision. NOTE: An algorithm may be used clinically to guide treatment decisions for an individual patient on the basis of the patient's clinical outcome or result. [after AMA Style Guide, 9th Edition]
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| alert |
To cause a high-priority signal (or warning) to be transmitted to the relevant stakeholder by way of the local system or another system (usually according to an established set of rules). For example, the system may transmit an alert to a patient's cardiologist that the patient has experienced another heart attack. another example is that the pharmacy system may transmit an alert to the prescribing physician that a potentially dangerous drug-drug interaction may occur based on the current list of medications. another example is that the system may notify a patient's physician that laboratory results (that are not within normal limits) are available. [HL7 EHR-SFM Glossary of Terms, 2010]
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| ALCOA + |
Acronym for a number of attributes or dimensions included in ALCOA, plus the following: Complete, Consistent, Enduring, and Available when needed. NOTE: ALCOA + is a recent way to summarily refer to the attributes or dimensions of data integrity.) After EMA Reflection Paper on eSOURCE in effect since 2010. See also WHO Annex V, Guidance on Good Data and Record Management Practices. See also ALCOA, data integrity.
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ALCOA Plus |
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