EP-4742255-A1 - SYSTEMS AND METHODS FOR AUTONOMOUS REAL-TIME GENERATION AND MODIFICATION OF A DYNAMIC ELECTRONIC TRIAL MASTER FILE

Abstract

Relates to autonomous real-time generation and modification of a dynamic hierarchical file structure for an electronic Trial Master File (eTMF). A method includes receiving, by an event processor, event messages from a message system integrating a plurality of applications, the applications configured to automatically generate messages in real time in response to events. The method further includes determining, by the event processor, for each event message, one or more hierarchical file structure placeholders associated with the corresponding activity based on the metadata of each said event message. The method further includes automatically modifying in real time, by the event processor, the hierarchical file structure to incorporate said one or more hierarchical file structure placeholders. The method further includes storing one or more documents received from the computer system at the first site in said one or more hierarchical file structure placeholders.

Inventors

• FRID-NIELSEN, MARTIN
• Chan, Yau Pan
• GLAVIN, Timothy
• RICHMOND, Kately
• NANDI, Umamaheswara

Assignees

• Medidata Solutions, Inc.

Dates

Publication Date

20260513

Application Date

20251111

Claims (15)

1. A computer-implemented method for autonomous real-time generation and modification of a dynamic hierarchical file structure for an electronic Trial Master File (eTMF), the method comprising: receiving, by an event processor, event messages from a message system integrating a plurality of applications, the applications configured to automatically generate messages in real time in response to events, wherein: each of the events corresponds to a user interaction with one of the applications via a user interface of a computer system at a first site based on an activity associated with the clinical trial, and each event message corresponding to each said user interaction comprises metadata relating to a corresponding activity; determining, by the event processor, for each event message, one or more hierarchical file structure placeholders associated with the corresponding activity based on the metadata of each said event message; automatically modifying in real time, by the event processor, the hierarchical file structure to incorporate said one or more hierarchical file structure placeholders; and storing one or more documents received from the computer system at the first site in said one or more hierarchical file structure placeholders.
2. The method of claim 1, wherein the metadata relating to the corresponding activity comprises one or more of: a site identifier associated with the site, a milestone identifier corresponding to the activity, and a role designation for a user associated with the activity.
3. The method of claim 1 or 2, further comprising automatically validating the one or more documents received from the computer system against predefined formats or compliance criteria before storing them in the hierarchical file structure placeholders.
4. The method of claim 1, 2 or 3, wherein determining, by the event processor, the one or more hierarchical file structure placeholders comprises dynamically applying one or more predefined templates from a template library, the templates specifying expected document types for activities associated with the clinical trial.
5. The method of any preceding claim, wherein automatically modifying in real time the hierarchical file structure comprises dynamically adapting the structure to fulfill region-specific requirements associated with the first site.
6. The method of any preceding claim, further comprising tracking the completeness of the hierarchical file structure placeholders across the plurality of sites, and generating real-time quantitative metrics for placeholders that are complete or pending at each site.
7. The method of any preceding claim, further comprising generating alerts when one or more placeholders remain unfulfilled beyond a predetermined compliance deadline, wherein the alerts are sent to designated users.
8. The method of any preceding claim, further comprising automatically replacing existing placeholders in the hierarchical file structure with updated placeholders in response to receiving event messages indicating changes to corresponding activities.
9. The method of any preceding claim, further comprising associating the one or more documents with placeholder-specific metadata, wherein the metadata includes document type, author, version, and applicable event identifier.
10. The method of any preceding claim, wherein the hierarchical file structure is configured to logically separate placeholders into zones and sections corresponding to study phases, trial sites, or geographic regions.
11. A system for autonomous real-time generation and modification of a dynamic hierarchical file structure for an electronic Trial Master File (eTMF), the system comprising: a computer having one or more processors in communication with a memory, the memory storing instructions executable by said one or more processors to perform: receiving, by an event processor, event messages from a message system integrating a plurality of applications, the applications configured to automatically generate messages in real time in response to events, wherein: each of the events corresponds to a user interaction with one of the applications via a user interface of a computer system at a first site based on an activity associated with the clinical trial, and each event message corresponding to each said user interaction comprises metadata relating to a corresponding activity; determining, by the event processor, for each event message, one or more hierarchical file structure placeholders associated with the corresponding activity based on the metadata of each said event message; automatically modifying in real time, by the event processor, the hierarchical file structure to incorporate said one or more hierarchical file structure placeholders; and storing one or more documents received from the computer system at the first site in said one or more hierarchical file structure placeholders.
12. The system of claim 11, wherein the metadata relating to the corresponding activity comprises one or more of: a site identifier associated with the site, a milestone identifier corresponding to the activity, and a role designation for a user associated with the activity.
13. The system of claim 11 or 12, wherein determining, by the event processor, the one or more hierarchical file structure placeholders comprises dynamically applying one or more predefined templates from a template library, the templates specifying expected document types for activities associated with the clinical trial.
14. The system of claim 11, 12 or 13, wherein automatically modifying in real time the hierarchical file structure comprises dynamically adapting the structure to fulfill region-specific requirements associated with the first site.
15. A computer-readable medium comprising instructions that, when executed by one or more processors of a computer, cause said one or more processors to perform then method of any of claims 1 to 10.

Description

FIELD The present disclosure generally relates to autonomous real-time generation and modification of a dynamic electronic Trial Master File. BACKGROUND The electronic Trial Master File (eTMF) serves as the central repository for various documents collected throughout the duration of a clinical trial. Regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and their counterparts in other countries, frequently inspect the eTMF to ensure that the clinical trial is being conducted in a compliant and regulated manner. Conventional approaches to creating an eTMF are predominantly manual and labor-intensive. Typically, these processes begin with defining the structure of the eTMF. This involves generating a file plan that outlines the relevant document types required for the trial. Teams then manually decide on the appropriate documentation based on the study's nature and create a hierarchical structure populated with placeholders for these documents. Such methods necessitate significant manual intervention, including the printing and scanning of documents. Once printed and filled out by hand, documents are scanned back into the system, reviewed, and then placed in the correct location within the eTMF's folder structure. This process is repeated for each document, leading to a highly time-consuming and inefficient workflow. As further example, ongoing quality control reviews are needed as regulations and/or the study changes over time (e.g., the addition or removal of sites). In conventional approaches, a file plan is created based on industry-standard reference models, e.g., the Clinical Data Interchange Standards Consortium (CDISC) Trial Master File Reference Model, which is the current standard in the field (the "TMF Reference Model"). This plan dictates the structure and types of documents needed, which are then manually inputted into the eTMF. Despite advancements in digital technologies, a substantial amount of paper is still used, as documents are often printed, filled out manually, and then scanned back into the system. Thus, overall, the current state of eTMF management is characterized by its manual nature, requiring significant human effort to review, categorize, and file documents appropriately. SUMMARY Particular aspects are set out in the appended independent claims. Various optional embodiments are set out in the dependent claims. In view of the deficiencies in conventional approaches discussed above, it is imperative to provide a technical solution to the technical problem of providing more efficient, automated solutions to streamline eTMF processes and enhance the productivity of clinical trial documentation management. Disclosed embodiments provide a system, computer-implemented method, and computer-readable medium for autonomous real-time generation and modification of a dynamic hierarchical file structure for an electronic Trial Master File (eTMF), the method includes receiving, by an event processor, event messages from a message system integrating a plurality of applications, the applications configured to automatically generate messages in real time in response to events. Each of the events corresponds to a user interaction with one of the applications via a user interface of a computer system at a first site based on an activity associated with the clinical trial, and each event message corresponding to each said user interaction comprises metadata relating to a corresponding activity. The method further includes determining, by the event processor, for each event message, one or more hierarchical file structure placeholders associated with the corresponding activity based on the metadata of each said event message. The method further includes automatically modifying in real time, by the event processor, the hierarchical file structure to incorporate said one or more hierarchical file structure placeholders. The method further includes storing one or more documents received from the computer system at the first site in said one or more hierarchical file structure placeholders. Embodiments may include one or more of the following features. The metadata relating to the corresponding activity may include one or more of: a site identifier associated with the site, a milestone identifier corresponding to the activity, and a role designation for a user associated with the activity. The method may include notifying, in real time, one or more users at the first site as placeholders are created in the hierarchical file structure. The method may include automatically validating the one or more documents received from the computer system against predefined formats or compliance criteria before storing them in the hierarchical file structure placeholders. The determining, by the event processor, of the one or more hierarchical file structure placeholders may include dynamically applying one or more predefined templates from a template library, the templates specifying expected document