Importance

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Abstract

A system and method for managing clinical trial data includes dynamically generating, at a server, a data entry form to be displayed at a client. The data entry form is generated dynamically in a SGML-derived language. Control elements within the form comprise images which are used to construct the control elements and larger controls. The form is generated from a protocol database and a context received from the client, is populated from the data database, and is published to the client. Templates based on the protocol database comprise several frames including intermediate frames for displaying frame borders which are non-horizontal and non-vertical. If the trial protocol changes during a trial, the generated form is based on the protocol version active at the time data was entered into the form. Inadvertent use of the application is discouraged requiring an authentication procedure and displaying a picture of the authenticated user. Furthermore, help is provided by creating a link between the text or each question and information about the question. The source of help may be any or all of a protocol document, an investigative brochure, and a study guide. In addition, a user, upon logging in, is presented with a dashboard screen which provides information or links to information such as trial-related news, alerts, statistical information, progress reports and a list of work to be completed.

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First Claim