To convert data by the use of a code in such a manner that reconversion to the original form is possible.
A format in which the output consists of structured field introducers and variable data rather than output in line format.
A device or program that separates data, signals, or material in accordance with specified criteria.
The Periodic Safety Update Report (PSUR) is required as part of the FDA Post Marketing Drug Risk Assessment (PMDRA) program. The PSUR software is designed to track the submission of Periodic Safety Update Reports by marketed product and country.
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.
A request for information from the database based on specific conditions. For example, a request for a all reports related to a particular study.
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.
A document file format developed by Microsoft for cross-platform document interchange.
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.
Any organized data collection system (such as adverse experience information derived from a clinical trial, patient registry, including pregnancy registries). Reports from company-sponsored patient support programs should be handled as if they were study reports and not as spontaneous reports.
Universal Resource Locator (URL)
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').
A client program that initiates requests to a Web server and displays the information that the server returns.
A software program that is capable of servicing Hypertext Transfer Protocol (HTTP) requests.
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.
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.