Clinical trial data management system and method

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 of 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.

1 - 26 . (canceled)  
   
   
       27 . A clinical trial data entry method, comprising: 
 displaying a form on a computer screen, the form having at least one question to which a user must respond to provide clinical data;    creating links between text of each question and detailed information related to the question; and    if the user clicks on text of the question, displaying detailed information corresponding to the question.    
   
   
       28 . The method of  claim 27  wherein the detailed information displayed is a help document defining the clinical trial.  
   
   
       29 . The method of  claim 28  wherein the help document is one of a protocol document, an investigative brochure, and a study guide.  
   
   
       30 . The method of  claim 28  wherein the help document comprises all of a protocol document, an investigative brochure, and a study guide.  
   
   
       31 . A clinical trial data entry method, comprising: 
 displaying a form on a computer screen, the form having at least one question to which a user must respond to provide clinical data;    upon a user request, displaying detailed information from any or all of a protocol document, an investigative brochure, and a study guide.    
   
   
       32 . The method of  claim 31  wherein the user can walk through each of the protocol document, investigative brochure and study guide.  
   
   
       33 . The method of  claim 32  wherein the detailed information displayed is from a section of the protocol document, investigative brochure, or study guide, which section pertains immediately to the question to which the user must respond.  
   
   
       34 - 52 . (canceled)  
   
   
       53 . A computer system for entering clinical trial data, comprising: 
 a form displayed on a computer screen, the form having at least one question to which a user must respond to provide clinical data; and    links between text of each question and detailed information related to the question, the detailed information existing in at least one on-line document, such that if the user clicks on text of the question, displaying detailed information corresponding to the question is displayed.    
   
   
       54 - 56 . (canceled)