Drug document production system

• US 20050216308A1
• Filed: 12/30/2004
• Published: 09/29/2005
• Est. Priority Date: 04/27/1995
• Status: Abandoned Application

• Current Assignee: Erik A. Martin, Kathy J. Nomides, Michael J. Umen, Phillip C. Wilson
• Original Assignee: Erik A. Martin, Kathy J. Nomides, Michael J. Umen, Phillip C. Wilson
• Inventors: Wilson, Phillip C., Martin, Erik A., Umen, Michael J., Nomides, Kathy J.
• Application Number:
  US11/026,089
• Publication Number:
  US 20050216308A1
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: G06F 40/166 Editing, e.g. inserting or deleting
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G06Q 30/02 Marketing; Price estimation or determination; Fundraising
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage
• CPC Class Codes: Y10S 707/99931 Database or file accessing
• CPC Class Codes: Y10S 707/99933 Query processing, i.e. searching

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

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.

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.

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.

53. The method of claim 46 wherein the database is in the form of a computer 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.

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.

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.