Glossary

.CSV

In computers, a CSV (comma-separated values) file contains the values in a table as a series of ASCII text lines organized so that each column value is separated by a comma from the next column's value and each row starts a new line.

Adverse Experience

Any adverse event (AE) associated with the use of a drug or biological product in humans, whether or not considered product-related, including the following: An adverse event occurring in the course of the use of a drug product in professional practice;An adverse event occurring from drug overdose whether accidental or intentional; An adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action. Reporting an adverse experience does not necessarily reflect a conclusion by the applicant or the FDA that the product caused or contributed to the adverse experience. Adverse experience is synonymous with adverse drug experience, adverse biological experience, adverse product experience, and adverse event.

Affiliate

Any individual or entity related by employment or organizational structure to the applicant, including all subsidiaries, whether domestic or foreign.

Applicant

An individual or entity who holds the new drug application (NDA), abbreviated new drug application (ANDA), or the biologics license application (BLA). For purposes of this glossary, this term includes any person whose name appears on the label of a marketed drug or licensed biological product as its manufacturer, packer, distributor, shared manufacturer, joint manufacturer, or any participant involved in divided manufacturing.

Causality Assessment

Determination of whether there is a reasonable possibility that the product is etiologically related to the adverse experience. Causality assessment includes (for example) assessment of temporal relationships, dechallenge/rechallenge information, association with (or lack of association with) underlying disease, presence (or absence) of a more likely cause, and physiologic plausibility.

Challenge

Administration of a suspect product by any route.

Chart

A picture defined in graphics primitives and graphics attributes.

Column

A character position within a print line or on display. The positions are numbered consecutively from 1, starting at the leftmost character position and extending to the rightmost position. In relational database, a field defined for a given record.

Command

A way to start database administration functions to access and maintain the database manager. A statement used to initiate an action or start a service. A command consists of the command name abbreviation, and its parameters and flags if applicable.

Data Mart

A subset of a data warehouse that contains data that is tailored and optimized for the specific reporting needs of a department or team. A data mart can be a subset of a warehouse for an entire organization, such as data that is contained in online analytical processing (OLAP) tools.

Data Mart ETL

In Data Warehouse, the extract, transform, and load (ETL) process that extracts a subset of data from the central data warehouse, transforms it, and loads it into one or more star schemas. These schemas then can be included in data marts to answer specific business questions.

Data Mining

The process of collecting critical business information from a data warehouse, correlating the information and uncovering associations, patterns, and trends.

Data Warehouse

A central repository for all or significant parts of the data that an organization's business systems collect. A subject-oriented nonvolatile collection of data used to support strategic decision making. The warehouse is the central point of data integration for business intelligence. It is the source of data for data marts within an enterprise and delivers a common view of enterprise data.

Dechallenge

Withdrawal of a suspect product from the patients therapeutic regimen.

Disability

A substantial disruption in one's ability to conduct normal life functions.

Electronic Document

A document that is stored on the computer, instead of printed on paper.

Encode

Use the following procedure to convert data by the use of a code in such a manner that reconversion to the original form is possible.

Event Log

A log that contains information about events for a particular system or group, for a particular metric, or for all the events that are associated with a specific monitor.

Expected Adverse Experience

Adverse experience listed in the current FDA-approved labeling for the drug or licensed biological product. This would include any section of the labeling that refers to adverse experience information.

Field

In a record, a specified area used for a particular category of data. For example, a record about an employee might be subdivided into fields containing the employee's name, address, and salary.

Field Description

Information that describes the characteristics of data in a field.

Field Format

A format in which the output consists of structured field introducers and variable data rather than output in line format.

Filter

A device or program that separates data, signals, or material in accordance with specified criteria.

Form

In query management, an object that describes how to format the data for printing or displaying a report. A display screen, printed document, or file with defined spaces for information to be inserted.

Home Page

The top-level web page of a portal. Sometimes used as a synonym for default portal page.

Initial Reporter

The original source of information concerning an adverse experience (e.g., consumer, healthcare professional).

Life-threatening Adverse Experience

An adverse experience that in the view of the initial reporter, places the patient at immediate risk of death from the adverse experience as it occurred. It does not include an adverse experience that, had it occurred in a more severe form, might have caused death.

Negative Dechallenge

Continued presence of an adverse experience after withdrawal of the suspect product.

Negative Rechallenge

Failure of the product, when reintroduced, to produce signs or symptoms similar to those observed when the suspect product was previously introduced.

Positive Dechallenge

Partial or complete disappearance of an adverse experience after withdrawal of the suspect product.

Positive Rechallenge

Reoccurrence of similar signs and symptoms upon reintroduction of the suspect product.

Query

A request for information from the database based on specific conditions.

Rechallenge

Reintroduction of a suspect product suspected of having caused an adverse experience following a positive dechallenge.

Report

In query management, the formatted data that results from running a query and applying a form to it. Data that has been selected and extracted according to the reporting tool, the type of report desired and formatting criteria.

Report Type

A data source and how it is mapped.

Role

A job function that identifies the tasks that a user can perform and the resources to which a user has access. A user can be assigned one or more roles. A definition of the access levels that users have and the specific resources that they can modify at those levels. Users are limited in how they can access information if they do not have the proper role. Multiple roles are permissible.

Serious Adverse Experience

An adverse experience occurring from any dose that results in any of the following outcomes:· Death· Life-threatening adverse experience · Initial inpatient hospitalization· Prolongation of hospitalization Significant or persistent disability/incapacity Congenital anomaly/birth defect (including that occurring in a fetus);· Important medical events, based upon appropriate medical judgment, that may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed above.

Spontaneous Report

A communication from an individual (e.g. health care professional, consumer) to a company or regulatory authority that describes a suspected adverse experience. It does not include cases identified from information solicited by the applicant such as individual cases or findings derived from a study.

Study

Any organized data collection system (e.g., adverse experience information derived from a clinical trial, patient registry including pregnancy registries). Reports from company sponsored patient support programs and disease management programs should be handled as if they were study reports and not as spontaneous reports.

Suspect Product

Drug or biological product associated with an adverse experience as determined by the initial reporter, regardless of the opinion of the applicant.

Type Ahead

The functionality that offers you to type-in a value and the like values are displayed in the listbox. It also enables you to select the desired value from the list of values.

Unexpected Adverse Experience

Adverse experience not included in any section of the current FDA-approved labeling for the drug or licensed biological product. This includes an adverse experience that may differ from a labeled adverse experience because of greater severity or specificity (e.g., abnormal liver function versus hepatic necrosis). Adverse experiences listed as occurring with a class of drugs or biological products but not specifically mentioned with a particular drug or biological product are considered unexpected (e.g., rash with antibiotic X would be unexpected if the labeling said "rash may be associated with antibiotics"). This is because the labeling does not specifically state "rash is associated with antibiotic X." Reports of death from an adverse experience are considered unexpected unless the possibility of a fatal outcome from that adverse experience is stated in the labeling.

Web-based Application

An application that is downloaded from the Web each time it is run. The advantage is that the application can be run from any computer, and the software is routinely upgraded and maintained by the hosting organization rather than by each individual user.

Web Browser

A client program that initiates requests to a Web server and displays the information that the server returns.

Web Page

Any document that can be accessed by a URL on the World Wide Web.

Web Server

A software program that is capable of servicing Hypertext Transfer Protocol (HTTP) requests

Web Site

A related collection of files available on the Web that is managed by a single entity (an organization or an individual) and contains information in hypertext for its users. A Web site often includes hypertext links to other Web sites.