Spontaneous adverse events reporting

• US 20050197547A1
• Filed: 03/22/2005
• Published: 09/08/2005
• Est. Priority Date: 05/15/2001
• Status: Abandoned Application

• Current Assignee: Global Safety Surveillance, Inc. (Merck & Co., Inc.)
• Original Assignee: Global Safety Surveillance, Inc. (Merck & Co., Inc.)
• Inventors: Trinks, Uwe, Sugerman, Michael
• Application Number:
  US11/085,960
• Publication Number:
  US 20050197547A1
• Time in Patent Office: Days
• US Class Current: 600/300
• 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

1-33. -33. (canceled)

34. A program storage device readable by a machine, tangibly embodying a program of instructions executable by the machine to perform method steps of facilitating and structuring the intake, investigation, follow-up, analysis and reporting of adverse event and product complaint data, said method steps comprising:

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;

facilitating said user'"'"'s selecting of one or more of said selectable plurality of familiar popular 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; and

;

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.

35. The program storage device of claim 34 wherein prior to generating said report, generating a summary narrative for review based on at least said selected one or more of said selectable plurality of familiar popular terms and at least a portion of said selectable graphical depiction.

36. The program storage device of claim 34 further comprising transmitting said standardized report to an appropriate regulatory body.

37. The program storage device of claim 34 further comprising storing said popular and standardized terms associations in a storage medium.

38. The program storage device of claim 37 further comprising storing said standardized report in a storage medium.

39. The program storage device of claim 38 further comprising associating said selected one or more of said plurality of selectable popular 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.

40. The program storage device of claim 34 further comprising editing said reported adverse event data.

41. The program storage device of claim 34 wherein said plurality of popular terms comprises descriptive medical and diagnostic indicia.

42. The program storage device of claim 34 wherein said plurality of popular terms comprises performance measurement information.

43. The program storage device of claim 34 wherein said graphical depiction comprises an animal body and wherein said plurality of popular terms comprises related common descriptive terms.

44. The program storage device of claim 34 wherein said graphical depiction comprises a human body and wherein said plurality of popular terms comprises related common descriptive terms.

45. The program storage device of claim 34 wherein said graphical depiction comprises a product and wherein said plurality of popular terms comprises related common descriptive terms.

46. The program storage device of claim 34 wherein said graphical depiction comprises a mechanical system and wherein said plurality of popular terms comprises related common descriptive terms.

47. The program storage device of claim 34 wherein said graphical depiction comprises an electrical system and wherein said plurality of popular terms comprises related common descriptive terms.

48. The program storage device of claim 34 wherein said graphical depiction comprises a biological system and wherein said plurality of popular terms comprises related common descriptive terms.

49. The program storage device of claim 34 wherein said graphical depiction comprises a chemical system and wherein said plurality of popular terms comprises related common descriptive terms.

50. The program storage device of claim 34 wherein said graphical depiction comprises a hybrid system and wherein said plurality of popular terms comprises related common descriptive terms.