US2005216308A1PendingUtilityA1

Drug document production system

66
Individually held — no corporate assignee on recordPriority: Apr 27, 1995Filed: Dec 30, 2004Published: Sep 29, 2005
Est. expiryApr 27, 2015(expired)· nominal 20-yr term from priority
Inventors:Michael J. UmenKathy J. NomidesPhillip C. WilsonErik Martin
G06Q 10/10Y10S707/99933G06F 40/166Y10S707/99931G06Q 30/02G16H 40/63G16H 10/20G16H 15/00G16H 70/40
66
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Claims

Abstract

A document production system is provided for preparing documents and managing a database of information pertaining to investigational studies of medical products. The document production system includes a data management user interface for providing user access to the database and for retrieving information from the database as specified by selected document templates for placement into published documents. Additionally, the data management user interface is capable of updating information stored within the database in accordance with information specified within a previously prepared document.

Claims

exact text as granted — not AI-modified
1 . A method of producing a document for regulatory approval of a drug, comprising: 
 conducting at least one clinical study of the drug;    entering data objects pertaining to the clinical study into a database;    providing a template for use with a computer for identifying a set of data objects for regulatory approval of a drug;    providing a computer-generated status report indicating whether the data objects of the template conform to a predetermined completion criteria; and    extracting data objects pertaining to the selected study from the database to generate a document compatible with a document publishing system for regulatory approval of a drug.    
   
   
       2 . The method of  claim 1 , wherein said step of entering data objects into the database comprises the step of specifying graphical data objects.  
   
   
       3 . The method of  claim 1 , wherein the step of providing a computer-generated status report comprises the step of designating data objects pertaining to the clinical study which have not been associated into the template.  
   
   
       4 . The method of  claim 3  wherein said step of entering data objects pertaining to the clinical study comprises the step of entering at least one of a drug name, a study design, a treatment group, and a dose.  
   
   
       5 . The method of  claim 1  wherein said step of entering data objects pertaining to the clinical study comprises the step of identifying a data object type for at least some of the data objects.  
   
   
       6 . The method of  claim 5  comprising the step of identifying the data object type as one of a drug name, a study design, a treatment group, and a dose.  
   
   
       7 . The method of  claim 5  comprising the step of identifying the data object type as a graphical data object.  
   
   
       8 . The method of  claim 5  comprising the step of identifying the data object type as a statistical data object.  
   
   
       9 . The method of  claim 5 , comprising the step of providing said template in accordance with specifications established by a regulatory agency.  
   
   
       10 . The method of  claim 1 , comprising the step of inserting a data object into a generated document as a hyperlink.  
   
   
       11 . A method of processing data for production of a medical study document, comprising the steps of: 
 storing the data items in a database for use in producing the medical study document;    providing an electronic document in the form of a file having data items therein pertaining to a medical study;    locating the data items in the database;    retrieving the data items from the database on the basis of the data items in the electronic document; and    submitting at least a portion of the electronic document to a regulatory agency.    
   
   
       12 . The method of  claim 11  wherein said step of storing data items in the database comprises the step of specifying graphical data objects.  
   
   
       13 . The method of  claim 11  wherein said step of storing data items comprises the step of entering at least one of a drug name, a study design, a treatment group, and a dose.  
   
   
       14 . The method of  claim 11  wherein said step of storing data items comprises the step of indicating a data object type for at least some of the data items.  
   
   
       15 . The method of  claim 14  comprising the step of identifying a data object type as one of a drug name, a study design, a treatment group, and a dose.  
   
   
       16 . The method of  claim 14  comprising the step of identifying a data object type as a graphical data object.  
   
   
       17 . The method of  claim 14  comprising the step of identifying a data object type as a statistical data object.  
   
   
       18 . The method of  claim 11  comprising the step of providing said electronic document pursuant to a template in accordance with specifications established by a regulatory agency.  
   
   
       19 . The method of  claim 11  comprising the step of inserting a data object into the document as a hyperlink.  
   
   
       20 . A method of producing a document for regulatory approval of a drug, comprising: 
 conducting at least one study of the drug;    entering data objects pertaining to the study into a database;    providing a template for use with a computer for identifying a set of data objects for regulatory approval of a drug;    providing a computer-generated status report indicating whether the data objects of the template conform to a predetermined completion criteria; and    extracting data objects pertaining to the selected study from the database to generate a document compatible with a document publishing system for regulatory approval of a drug.    
   
   
       21 . The method of  claim 20 , wherein said step of entering data objects into the database comprises the step of specifying graphical data objects.  
   
   
       22 . The method of  claim 20 , wherein the step of providing a computer-generated status report comprises the step of designating data objects pertaining to the study which have not been associated into the template.  
   
   
       23 . The method of  claim 22  wherein said step of entering data objects pertaining to the study comprises the step of entering at least one of a drug name, a study design, a treatment group, and a dose.  
   
   
       24 . The method of  claim 20  wherein said step of entering data objects pertaining to the study comprises the step of identifying a data object type for at least some of the data objects.  
   
   
       25 . The method of  claim 24  comprising the step of identifying the data object type as one of a drug name, a study design, a treatment group, and a dose.  
   
   
       26 . The method of  claim 24  comprising the step of identifying the data object type as a graphical data object.  
   
   
       27 . The method of  claim 24  comprising the step of identifying the data object type as a statistical data object.  
   
   
       28 . The method of  claim 24 , comprising the step of providing said template in accordance with specifications established by a regulatory agency.  
   
   
       29 . The method of  claim 20 , comprising the step of inserting a data object into a generated document as a hyperlink.  
   
   
       30 . A method of processing data for production of a medical study document, comprising the steps of: 
 storing data items in a database for use in producing the medical study document;    providing an electronic document in the form of a file having data items therein pertaining to a medical study;    locating the data items in the database;    retrieving the data items from the database on the basis of the data items required in the electronic document to create at least a portion of the medical study document; and    submitting at least a portion of the medical study document to a regulatory agency.    
   
   
       31 . The method of  claim 30  wherein said step of storing data items in the database comprises the step of specifying graphical data objects.  
   
   
       32 . The method of  claim 30  wherein said step of storing data items comprises the step of entering at least one of a drug name, a study design, a treatment group, and a dose.  
   
   
       33 . The method of  claim 30  wherein said step of storing data items comprises the step of indicating a data object type for at least some of the data items.  
   
   
       34 . The method of  claim 33  comprising the step of identifying a data object type as one of a drug name, a study design, a treatment group, and a dose.  
   
   
       35 . The method of  claim 33  comprising the step of identifying a data object type as a graphical data object.  
   
   
       36 . The method of  claim 33  comprising the step of identifying a data object type as a statistical data object.  
   
   
       37 . The method of  claim 30  comprising the step of providing said electronic document pursuant to a template in accordance with specifications established by a regulatory agency.  
   
   
       38 . The method of  claim 30  comprising the step of inserting a data object into the document as a hyperlink.  
   
   
       39 . The method of  claim 30  including the steps of: 
 providing an identification of at least selected data items pertaining to the study to be entered into a database; and    providing additional information about a particular data items in response to an inquiry for additional information about a particular data item.    
   
   
       40 . The method of  claim 46  wherein the step of providing an identification of at least selected data objects pertaining to the study to be entered into a database includes displaying indicia of the selected data objects on a screen.  
   
   
       41 . The method of  claim 47  wherein the step of providing additional information includes displaying the additional information about a particular data object on the screen in response to the inquiry for additional information about the particular data object.  
   
   
       42 . The method of  claim 48  wherein the step of displaying indicia of the selected data objects on a screen includes displaying the indicia on a part of the screen and the step of displaying additional information includes displaying the additional information on another part of the screen.  
   
   
       43 . The method of  claim 49  wherein the inquiry for additional information includes the step of moving a cursor on the screen to the respective indicia of the particular data object displayed on the screen.  
   
   
       44 . The method of  claim 50  wherein the step of displaying the additional information on the screen includes the step of displaying such additional information about a particular data object in response to the movement of the cursor on the screen to the respective indicia of the particular data object.  
   
   
       45 . The method of  claim 38  wherein the database is in the form of a computer file system.  
   
   
       46 . A method of producing a medical study document for submission to a regulatory agency, comprising the steps of: 
 entering data items pertaining to a medical study in a computer file system;    providing a template for reporting the medical study, in accordance with a format prescribed by the regulatory agency, the template containing references to data items to be included in a report of the medical study for submission to the regulatory agency;    associating data items with the template, including the step of generating an index of data items in the file system;    generating a status display indicating whether referenced data items in the template have been associated with corresponding data items in the file system.    
   
   
       47 . A method of producing a document for regulatory approval of a drug, comprising: 
 conducting at least one study of the drug;    providing an identification of at least selected data objects pertaining to the study to be entered into a database;    providing additional information about a particular data object in response to an inquiry for additional information about a particular data object;    entering data objects pertaining to the study into the database;    providing a template for use with a computer for identifying a set of data objects for regulatory approval of a drug; and    extracting data objects pertaining to the selected study from the database in association with the template to generate a document for regulatory approval of a drug.    
   
   
       48 . The method of  claim 47  wherein the step of providing an identification of at least selected data items pertaining to the study to be entered into a database includes displaying indicia of the selected data items on a screen.  
   
   
       49 . The method of  claim 48  wherein the step of providing additional information includes displaying the additional information about a particular data item on the screen in response to the inquiry for additional information about the particular data item.  
   
   
       50 . The method of  claim 49  wherein the step of displaying indicia of the selected data items on a screen includes displaying the indicia on a section of the screen and the step of displaying additional information includes displaying the additional information on another part of the screen.  
   
   
       51 . The method of  claim 50  wherein the inquiry for additional information includes the step of moving a cursor on the screen to the respective indicia of the particular data item displayed on the screen.  
   
   
       52 . The method of  claim 51  wherein the step of displaying the additional information on the screen includes the step of displaying such additional information about a particular data item in response to the movement of the cursor on the screen to the respective indicia of the particular data item.  
   
   
       53 . The method of  claim 46  wherein the database is in the form of a computer file system.

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