Autonomous Real-Time eTMF Generation and Modification System and Method

Abstract

This invention provides a computer implementation method for autonomously generating and modifying a dynamic hierarchical file structure for an Electronic Trial Master File (eTMF) in real time. [Solution] The method involves an event processor receiving multiple event messages from a message system that integrates multiple applications for automatically generating messages in real time in response to the occurrence of multiple events. For each event message, the system determines one or more hierarchical file structure placeholders related to the corresponding action based on the metadata of the event message. The system automatically modifies the hierarchical file structure in real time to incorporate one or more hierarchical file structure placeholders, and stores one or more documents received from the computer system of the first facility in one or more hierarchical file structure placeholders.

Claims

1. A computer implementation method for autonomously generating and modifying a dynamic hierarchical file structure for an electronic trial master file (eTMF) in real time, A receiving step in which an event processor receives multiple event messages from a message system that integrates multiple applications for automatically generating messages in real time in response to the occurrence of multiple events, wherein each of the multiple events is an event corresponding to a user operation of one of the multiple applications via the user interface of a computer system of a first facility, based on an activity related to a clinical trial, and each of the event messages corresponding to the user operation includes metadata related to the corresponding operation. The event processor, for each event message, determines one or more hierarchical file structure placeholders related to the corresponding operation based on the metadata of the event message, To incorporate the one or more hierarchical file structure placeholders, the event processor performs an automatic change step in which it automatically changes the hierarchical file structure in real time. The steps include storing one or more documents received from the computer system of the first facility in one or more hierarchical file structure placeholders, Computer implementation methods including

2. The computer implementation method according to claim 1, wherein the metadata related to the corresponding operation includes at least one of a facility identifier associated with the first facility, a milestone identifier corresponding to the corresponding operation, and a user role designation associated with the corresponding operation.

3. The computer implementation method according to claim 1, further comprising the step of automatically verifying whether one or more documents received from the computer system conform to a predefined format or criteria before saving them to the hierarchical file structure placeholder.

4. The computer implementation method according to claim 1, wherein when the event processor determines the one or more hierarchical file structure placeholders, one or more predetermined templates defining the document types required for the activities related to the clinical trial are dynamically applied from a template library.

5. The computer implementation method according to claim 1, wherein the automatic change step dynamically adapts the structure to meet region-specific requirements related to the first equipment.

6. The computer implementation method according to claim 1, further comprising the steps of tracking the integrity of the hierarchical file structure placeholders spanning multiple facilities and generating real-time quantitative indicators for completed or pending placeholders at each facility.

7. The computer implementation method according to claim 1, which generates an alert to be sent to a designated user if one or more placeholders remain unfulfilled after a predetermined compliance deadline has passed.

8. The computer implementation method according to claim 1, further comprising the step of automatically replacing existing placeholders in the hierarchical file structure with updated placeholders in response to the receipt of an event message indicating a change to corresponding operation.

9. The computer implementation method according to claim 1, further comprising the step of associating one or more documents with metadata that includes placeholder-specific document type, author, version, and event identifier.

10. The computer implementation method according to claim 1, wherein the hierarchical file structure is configured to logically distribute placeholders to zones and sections corresponding to the phase of a clinical trial, the site of the trial, or the geographical area.

11. A computer comprising one or more processors communicating with memory containing executable instructions, and a system that autonomously generates and modifies a dynamic hierarchical file structure for an electronic Trial Master File (eTMF) in real time, A receiving step in which an event processor receives multiple event messages from a message system that integrates multiple applications for automatically generating messages in real time in response to the occurrence of multiple events, wherein each of the multiple events is an event corresponding to a user operation of one of the multiple applications via the user interface of a computer system of a first facility, based on an activity related to a clinical trial, and each of the event messages corresponding to the user operation includes metadata related to the corresponding operation. The event processor, for each event message, determines one or more hierarchical file structure placeholders related to the corresponding operation based on the metadata of the event message, To incorporate the one or more hierarchical file structure placeholders, the event processor performs an automatic change step in which it automatically changes the hierarchical file structure in real time. The steps include storing one or more documents received from the computer system of the first facility in one or more hierarchical file structure placeholders, A system that executes this process.

12. The system according to claim 11, wherein the metadata related to the corresponding operation includes at least one of a facility identifier associated with the first facility, a milestone identifier corresponding to the corresponding operation, and a user role designation associated with the corresponding operation.

13. The system according to claim 11, further comprising the step of automatically verifying whether one or more documents received from the computer system conform to a predefined format or criteria before saving them to the hierarchical file structure placeholder.

14. The system according to claim 11, wherein when the event processor determines the one or more hierarchical file structure placeholders, one or more predetermined templates defining the document types required for the activities related to the clinical trial are dynamically applied from a template library.

15. A non-volatile computer-readable medium that stores instructions for one or more processors of a computer to perform an autonomous real-time generation and modification method for a dynamic hierarchical file structure for an electronic Trial Master File (eTMF), The autonomous real-time generation and modification method is A receiving step in which an event processor receives multiple event messages from a message system that integrates multiple applications for automatically generating messages in real time in response to the occurrence of multiple events, wherein each of the multiple events is an event corresponding to a user operation of one of the multiple applications via the user interface of a computer system of a first facility, based on an activity related to a clinical trial, and each of the event messages corresponding to the user operation includes metadata related to the corresponding operation. The event processor, for each event message, determines one or more hierarchical file structure placeholders related to the corresponding operation based on the metadata of the event message, To incorporate the one or more hierarchical file structure placeholders, the event processor performs an automatic change step in which it automatically changes the hierarchical file structure in real time. The steps include storing one or more documents received from the computer system of the first facility in one or more hierarchical file structure placeholders, Computer-readable media including [specific text].

16. The autonomous real-time generation and modification method is The computer-readable medium according to claim 15, further comprising the steps of tracking the integrity of the hierarchical file structure placeholders spanning multiple devices and generating real-time quantitative indicators for completed or pending placeholders at each device.

17. The computer-readable medium according to claim 15, wherein when the event processor determines the one or more hierarchical file structure placeholders, one or more predetermined templates defining the document types required for the activities related to the clinical trial are dynamically applied from a template library.

18. The computer-readable medium according to claim 15, wherein the automatic change step dynamically adapts the structure to meet region-specific requirements related to the first equipment.

19. The autonomous real-time generation and modification method is The computer-readable medium according to claim 15, further comprising the step of automatically replacing existing placeholders in the hierarchical file structure with updated placeholders in response to the receipt of an event message indicating a change to corresponding behavior.

20. The computer-readable medium according to claim 15, wherein the hierarchical file structure is configured to logically distribute placeholders to zones and sections corresponding to clinical trial phases, trial sites, or geographical areas.

Images