Clinical trial data management system and method

• US 6,820,235 B1
• Filed: 06/05/1998
• Issued: 11/16/2004
• Est. Priority Date: 06/05/1998
• Status: Expired due to Term

• Current Assignee: Oracle International Corporation (Oracle Corporation)
• Original Assignee: Phase Forward Incorporated (Oracle Corporation)
• Inventors: Stamos, Nicholas, Dale, Richard M., Bleicher, Paul A., Klofft, Jeffrey P.
• Primary Examiner(s): Feild, Joseph
• Assistant Examiner(s): Bashore, William L
• Application Number:
  US09/092,441
• Time in Patent Office: 2,356 Days
• Field of Search: 707/501.1, 707/104.1, 707/104, 705/2, 705/3, 600/300, 348/161, 435/6, 715/501.1, 715/512
• US Class Current: 715/236
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage

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.

Claims

1. A method of constructing a graphical user interface (GUI) form, comprising the steps of:

creating a protocol database which is specific to an application for which data is input and displayed through a client browser, and a data database which is specific to a subject processed by the application;

dynamically generating a form document by automatically selecting and assembling template fragments from a library of template fragments according to structural information stored in the protocol database and a client context, the structural information defining hierarchies of document objects, identifying plural selectable items within plural groups of items in the form, associated with template fragments;

populating the generated form document with application data from the data database, said data associated with the selected template fragments; and

publishing the populated template via a content server to the client browser as an SGML-derived form for input and display of data for the application.

2. The method of claim 1, the populated document comprising plural instances of at least one bitmap, each said bitmap instance being combined with at least one other bitmap instance to construct least one control element, the method further comprising:

receiving the data entry form from the client, clinical trial data having been entered into the form at the client; and

storing, at the server, the received clinical trial data.

3. The method of claim 2, further comprising:

displaying, at a client, selected clinical trial data based on at least one of;

a user, a patient, a protocol version within a clinical trial, and data previously entered.

4. The method of claim 2 wherein selected bitmaps are combined to construct a control element by placing indicators to the selected bitmaps in certain locations within the form, the browser correctly displaying the control element based on the indicators and their locations within the form.

5. The method of claim 4, the selected bitmaps including at least one instance of the least one bitmap.

6. The method of claim 2 further comprising the steps of:

partitioning a portion of the form into multiple bitmaps;

associating each different bitmap with a different indicator; and

associating different instances of a single bitmap with a common indicator.

7. The method of claim 2 wherein the form includes a tab control, a single tab of the tab control comprising a first-side bitmap, a second-side bitmap, and a center bitmap.

8. The method of claim 7 wherein a single bitmap is shared between two adjacent tabs, the shared bitmap serving as the first-side bitmap for a first of the adjacent tabs and as the second-side bitmap for a second of the adjacent tabs.

9. The method of claim 2 wherein the form includes a linear control, the linear control comprising:

button control elements spaced at intervals along a line, wherein each button control element is a bitmap or combination of bitmaps; and

a pointer bit map to indicate a current value along the line.

10. The method of claim 2 wherein the SGML-derived form is defined with HTML.

11. The method of claim 2 wherein the SGML-derived form is defined with XML.

12. The method of claim 2 wherein the server is stateless with respect to the form'"'"'s control elements.

13. The method of claim 2 wherein the indicators are uniform resource locators (URLs).

14. The method of claim 2 wherein the certain locations are table entries.

15. The method of claim 1 wherein generating the form document is further based on the data database.

16. The method of claim 1 wherein the protocol database is based on a clinical protocol.

17. The method of claim 1 wherein the template comprises a plurality of frames including control frames comprising one or more control elements, and an intermediate frame presenting a visual attribute shared by control frames to which it is adjacent, appearance of the intermediate frame depending on visual states of the adjacent control frames.

18. The method of claim 1, wherein generating the form document further comprises:

creating a plurality of bitmaps which selectively and in combination may be constricted to present a GUI control element in any of plural states;

specifying the form document as a Standard Generalized Markup Language (SGML)-derived document;

and placing the bitmaps within the form document such that upon receipt of the document at the browser, the browser will display a desired GUI control.

19. The method of claim 1, further comprising

changing a first protocol version to a second protocol version;

and wherein

generating a form document is further based on a protocol version which was active at time of entering data to be displayed.

20. The method of claim 1 wherein rules associated with the displayed for are based on the protocol version which was active at the time of entering data to be displayed in the form.

21. The method of claim 1, further comprising:

discouraging inadvertent use by

requiting an authentication procedure for each user, and

displaying a picture of an authenticated user.

22. The method of claim 1, wherein the populated form document has at least one question to which a user must respond to provide clinical data, further comprising:

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.

23. The method of claim 22 wherein the detailed information displayed is a help document defining the clinical trial.

24. The method of claim 23 wherein the help document is one of a protocol document, an investigative brochure, and a study guide.

25. The method of claim 23 wherein the help document comprises all of a protocol document, an investigative brochure, and a study guide.

26. The method of claim 25 wherein the user can walk through each of the protocol document, investigative brochure and study guide.

27. The method of claim 26 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.

28. The method of claim 1, wherein the application is a clinical trial application, the method further comprising the steps of:

providing a user login procedure;

upon a user logging in presenting to the user a dashboard screen comprising information regarding the trial, the dashboard screen being customized for the user.

29. The method of claim 28 wherein the information comprises trial-related news.

30. The method of claim 28 wherein the information comprises alerts.

31. The method of claim 28 wherein the information comprises statistical information.

32. The method of claim 28 wherein the information comprises progress reports.

33. The method of claim 28 wherein the information comprises a list of work to be completed.

34. The method of claim 1 wherein the application is a clinical trial.

35. The method of claim 1, at least one template fragment including a script which implements at least one rule.

36. The method of claim 35, the at least one rule checking for inconsistencies in data entered into the form.

37. A system for constructing a graphical user interface (GUI) form, comprising:

a protocol database which is specific to an application for which data is input and displayed through a client browser;

a data database which is specific to a subject processed by the application;

a generator which dynamically generates a form document by automatically selecting and assembling template fragments from a library of template fragments according to structural information stored in the protocol database and a client context, the structural information defining hierarchies of document objects, identifying plural selectable items within plural groups of items in the form, associated with template fragments;

a populator which populates the generated form document with application data from the data database, said data associated with the selected template fragments; and

a content server which publishes the populated template to the client browser as an SGML-derived form for input and display of data for the application.

38. The system of claim 37, the populated document comprising plural instances of at least one bitmap, each said bitmap instance being combined with at least one other bitmap instance to construct at least one control element, the system further comprising:

means for receiving the data entry form from the client, clinical trial data having been entered into the form at the client; and

a server for storing the received clinical trial data.

39. The system of claim 38 wherein selected bitmaps are combined to construct a control element is specified by placement of indicators to the selected bitmaps in certain locations within the form, the browser correctly displaying the control element based con the indicators and their locations within the form.

40. The system of claim 39 wherein the indicators are uniform resource locators (URLs).

41. The system of claim 39 wherein the certain locations are table entries.

42. The system of claim 38 wherein the form comprises multiple bitmaps, each different bitmap being associated with a different indicator, and different instances of a single bitmap bring associated with a common indicator.

43. The system of claim 38 wherein the SGML-derived form is defined with HTML.

44. The system of claim 38 wherein the server is stateless with respect to the form'"'"'s control elements.

45. The system of claim 38, wherein selected clinical trial data are displayed at a client, the selection being based on at least one of:

a user, a patient, a protocol version within a clinical trial, and data previously entered.

46. The system of claim 38, further comprising:

an authentication procedure for each user; and

a picture display, within the form, of an authenticated user.

47. The system of claim 38, wherein the form has 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.

48. The system of claim 37, the template comprising:

an intermediate frame which presents a visual attribute shared by control frames to which it is adjacent, appearance of the intermediate frame depending on visual states of the adjacent control frames.

49. A system for constructing a graphical user interface (GUI) form, comprising:

protocol database means specific to an application for which data is input and displayed through a client browser, and data database means which is specific to a subject processed by the application;

generation means for dynamically generating a form document by automatically selecting and assembling template fragments from a library of template fragments according to structural information stored in the protocol database means and a client context, the structural information defining hierarchies of document objects, identifying plural selectable items within plural groups of items in the form, associated with template fragments;

populating means for populating the generated form document with application data from the data database means, said data associated with the selected template fragments; and

publishing means for publishing the populated template via a content server to the client browser as an SGML-derived form for input and display of data for the application.