Glossary

Clinical Trial

A research study. The most commonly performed clinical trials evaluate new drugs, medical devices, biologics, or other interventions on patients in strictly scientifically controlled settings, and are required for regulatory authority approval of new therapies.

Electronic Document

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

Encode

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

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.

Home Page

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

Lower Level Term

The MedDRA dictionary is organized by System Organ Class (SOC), divided into High-Level Group Terms (HLGT), High-Level Terms (HLT), Preferred Terms (PT) and finally into Lower-Level Terms (LLT). The Current MedDRA version is 9.0 (March 2006).

MedDRA

A clinically validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry throughout the entire regulatory process, from pre-marketing to post-marketing activities, and for data entry, retrieval, evaluation, and presentation. In addition, it is the adverse event classification dictionary endorsed by the ICH (International Conference on Harmonization). MedDRA is used in the US, European Union, and Japan. Its use is currently mandated in Europe and Japan for safety reporting.

Portable Document Format

Portable Document Format (PDF) is a file format proprietary to Adobe Systems for representing two-dimensional documents in a device independent and resolution independent fixed-layout document format.

Report

A formatted presentation of information relating to a model or to process simulation results. Reports can be viewed online, printed, or exported to a variety of file formats. Data that has been selected and extracted according to the reporting tool, the type of report desired, and formatting criteria

Rich Text Format (RTF)

A document file format developed by Microsoft for cross-platform document interchange.

Text

A broad term for something that contains words to express something

Universal Resource Locator

In addition to identifying a resource, URLs provide a means of locating the resource by describing its primary access mechanism (e.g., its network 'location').

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.