Spontaneous adverse events reporting

• US 6,952,695 B1
• Filed: 05/15/2001
• Issued: 10/04/2005
• Est. Priority Date: 05/15/2001
• Status: Expired due to Term

• Current Assignee: Global Safety Surveillance, Inc. (Merck & Co., Inc.)
• Original Assignee: Global Safety Surveillance, Inc. (Merck & Co., Inc.)
• Inventors: Trinks, Uwe, Sugerman, Michael
• Primary Examiner(s): Alam, Shahid
• Assistant Examiner(s): EHICHIOYA, FRED I
• Application Number:
  US09/855,434
• Time in Patent Office: 1,603 Days
• Field of Search: 705/1, 705/3, 705/80, 705/5, 707/1, 707/2, 707/3, 707/4, 707/5, 707/10, 707/101, 707/102, 707/104, 709/218, 706/45, 706/52, 706/60, 715/513, 715/530, 600/300, 600/322, 600/411, 600/420, 600/430, 600/515
• US Class Current: 1/1
• CPC Class Codes: G06Q 10/02 Reservations, e.g. for tickets, services or events
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 70/60 relating to pathologies
• CPC Class Codes: Y10S 707/99931 Database or file accessing
• CPC Class Codes: Y10S 707/99937 Sorting
• CPC Class Codes: Y10S 707/99942 Manipulating data structure, e.g. compression, compaction, compilation
• CPC Class Codes: Y10S 707/99943 Generating database or data structure, e.g. via user interface
• CPC Class Codes: Y10S 707/99944 Object-oriented database structure
• CPC Class Codes: Y10S 707/99945 Object-oriented database structure processing

Abstract

A method of dynamically managing and improving the reliability, accuracy and quality of collected information comprising presenting the user with a hierarchically structured set of predefined terms, receiving reported information from a user corresponding to at least one of the predefined terms, structuring, categorizing and characterizing the reported information, dynamically converting the reported information into a standardized output and storing the standardized output.

Claims

1. A computer-based method of facilitating and structuring the intake, investigation, follow-up, analysis and reporting of adverse event and product complaint data;

said method comprising;

associating each one of a selectable plurality of familiar popular terms with one or more related standardized terms;

providing a user interface having said selectable plurality of familiar popular terms and a related selectable graphical depiction to enable a user to

     1) report adverse events and product complaints data associated with said selectable graphical depiction,

     2) review said reported data for accuracy and

     3) monitor said reported data; and

;

said user using said interface, selecting one or more of said selectable plurality of familiar terms and at least a portion of said selectable graphical depiction to describe an adverse event or product complaint associated with said selected portion of said selectable graphical depiction;

generating a standardized adverse event or product complaint report comprising said one or more related standardized terms associated with said selected one or more of said selectable plurality of familiar popular terms.

2. The method of claim 1 further comprising transmitting said standardized report to an appropriate regulatory body.

3. The method of claim 1 further comprising storing said popular and standardized terms associations in a storage medium.

4. The method of claim 3 further comprising storing said standardized report in a cage medium.

5. The method of claim 4 further comprising associating said selected one or more of said plurality of selectable poplar terms and related standardized term(s) with said selected at least a portion of said selectable graphical depiction and storing said associations in said storage medium.

6. The method of claim 1 further comprising editing said reported adverse event data.

7. The method of claim 1 wherein said plurality of popular terms comprises descriptive medical and diagnostic indicia.

8. The method of claim 1 wherein said plurality of popular terms comprises performance measurement information.

9. The method of claim 1 wherein said graphical depiction comprises an animal body and wherein said plurality of popular terms comprises related common descriptive terms.

10. The method of claim 1 wherein said graphical depiction comprises a human body and wherein said plurality of popular terms comprises related common descriptive terms.

11. The method of claim 1 wherein said graphical depiction comprises a product and wherein said plurality of popular terms comprises related common descriptive terms.

12. The method of claim 1 wherein said graphical depiction comprises a mechanical system and wherein said plurality of popular terms comprises related common descriptive terms.

13. The method of claim 1 wherein said graphical depiction comprises an electrical system and wherein said plurality of popular terms comprises related common descriptive terms.

14. The method of claim 1 wherein said graphical depiction comprises a biological system and wherein said plurality of popular terms comprises related common descriptive terms.

15. The method of claim 1 wherein said graphical depiction comprises a chemical system and wherein said plurality of popular terms comprises related common descriptive terms.

16. The method of claim 1 wherein said graphical depiction comprises a hybrid system and wherein said plurality of popular terms comprises related common descriptive terms.

17. A system for facilitating and structuring the intake, investigation, follow-up, analysis and reporting of adverse event and product complaint data, comprising:

a processor configured to;

associate each one of a plurality of selectable familiar popular terms with one or more related standardized terms;

generate a user interface having said familiar popular terms and a related selectable graphical depiction to enable a user to;

     1) report adverse events and product complaints data with said selectable graphical depiction,

     2) review said reported data for accuracy and

     3) monitoring said reported data;

process said user'"'"'s selected one or more of said plurality of familiar popular terns and selected at least a portion of said graphical depiction in accordance with a description of an adverse event or product complaint associated with said selected at least a portion of said graphical depiction; and

generate a standardized adverse event or product complaint report comprising said one or more related standardized terms associated with said selected familiar popular terms and graphical depiction.

18. The system of claim 17 wherein said processor is in communication with an appropriate regulatory body and is further configured to transmit said standardized report to said appropriate regulatory body.

19. The system of claim 17 further comprising a storage medium and wherein said processor is further configured to store said standardized report in said storage medium.

20. The system of claim 19 wherein said processor is further configured to store said popular and standardized terms associations in said storage medium.

21. The system of claim 20 wherein said processor is further figured to associate said selected one or more of said plurality of selectable popular teems and related standardized term(s) with said selected at least a portion of said selectable graphical depiction and storing said terms-graphical depiction associations in said storage medium.

22. The system of claim 17 wherein said processor is further configured to edit said reported adverse event data.

23. The system of claim 17 wherein said plurality of popular terms comprises medical and diagnostic indicia.

24. The system of claim 17 wherein said plurality of popular terms comprises performance measurement information.

25. The system of claim 17 wherein said graphical depiction comprises an animal body and wherein said plurality of popular terms related common descriptive tams.

26. The system of claim 17 wherein said graphical depiction comprises a human body and wherein said plurality of popular terms comprises related common descriptive terms.

27. The system of claim 17 wherein said graphical depiction comprises a product and wherein said plurality of popular terms comprises related common descriptive terms.

28. The system of claim 17 wherein said graphical depiction comprises a mechanical system and wherein said plurality of popular terms comprises related common descriptive terms.

29. The system of claim 17 wherein said graphical depiction comprises an electrical system and wherein said plurality of popular terms comprises related common descriptive terms.

30. The system of claim 17 wherein said graphical depiction comprises a biological system and wherein said plurality of popular terms comprises related common descriptive terms.

31. The system of claim 17 wherein said graphical depiction comprises a chemical system and wherein said plurality of popular terms comprises related common descriptive terms.

32. The system of claim 17 wherein said graphical depiction comprises a hybrid system and wherein said plurality of popular terms comprises related common descriptive terms.