CN-122019477-A - System and method for autonomous real-time generation and modification of dynamic electronic test master files

CN122019477ACN 122019477 ACN122019477 ACN 122019477ACN-122019477-A

Abstract

The present disclosure relates to a system and method for autonomous real-time generation and modification of a dynamic hierarchical file structure of an electronic test master file (eTMF). A method includes receiving, by an event processor, an event message from a messaging system that integrates a plurality of applications configured to automatically generate a message in real-time in response to the event. The method further includes determining, by the event processor, for each of the event messages, one or more hierarchical file structure placeholders associated with the respective activity based on the metadata of each of the event messages. The method further includes automatically modifying, by the event handler, the hierarchical file structure in real-time to include the one or more hierarchical file structure placeholders. The method further includes storing one or more documents received from the computer system of the first site in the one or more hierarchical file structure placeholders.

Inventors

Martin Fried Nielsen
CHEN YOUBIN
Tim Gavin
Caitlin Richmond
Umamaheswara Nandi

Assignees

MEDIDATA解决方案公司

Dates

Publication Date: 20260512
Application Date: 20251111
Priority Date: 20251024

Claims (12)

1. A computer-implemented method of autonomously generating and modifying a dynamic hierarchical file structure of an electronic test master file, i.e., a computer-implemented method of autonomously generating and modifying a dynamic hierarchical file structure of eTMF, the method comprising: Receiving, by an event processor, an event message from a messaging system integrating a plurality of applications configured to automatically generate a message in real-time in response to an event, wherein: Each event corresponds to a user interaction at the first site with one of the applications based on an activity associated with the clinical trial and via a user interface of the computer system, and Each event message corresponding to each of said user interactions contains metadata associated with the respective activity; determining, by the event processor, for each event message, one or more hierarchical file structure placeholders associated with the respective activity based on metadata of each of the event messages; automatically modifying the hierarchical file structure in real time by the event handler to include the one or more hierarchical file structure placeholders, and One or more documents received from a computer system of the first site are stored in the one or more hierarchical file structure placeholders.
2. The method of claim 1, wherein the metadata associated with the respective activity includes 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, further comprising automatically validating the one or more documents received from the computer system in accordance with a predefined format or compliance standard prior to storing the one or more documents in the hierarchical file structure placeholder.
4. The method of claim 1, 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 claim 1, wherein automatically modifying the hierarchical file structure in real-time includes dynamically adapting the structure to meet locale specific requirements associated with the first site.
6. The method of claim 1, further comprising tracking completion of the hierarchical file structure placeholders across multiple sites and generating quantitative metrics in real time for completed or pending placeholders at each site.
7. The method of claim 1, further comprising generating an alert when one or more placeholders remain unfilled beyond a predetermined compliance period, wherein the alert is sent to a designated user.
8. The method of claim 1, further comprising automatically replacing existing placeholders in the hierarchical file structure with updated placeholders in response to receiving an event message indicating a change in corresponding activity.
9. The method of claim 1, 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 claim 1, wherein the hierarchical file structure is configured to logically divide placeholders into regions and portions corresponding to research phases, trial sites, or geographic regions.
11. A system for autonomous real-time generation and modification of a dynamic hierarchical file structure of an electronic test master file, i.e., a system for autonomous real-time generation and modification of a dynamic hierarchical file structure of eTMF, the system comprising: A computer having one or more processors in communication with a memory, the memory storing instructions executable by the one or more processors to perform the method of any of claims 1-10.
12. A non-transitory computer readable medium storing instructions which, when executed by one or more processors of a computer, cause the one or more processors to perform the method of any of claims 1-10.

Description

System and method for autonomous real-time generation and modification of dynamic electronic test master files Technical Field The present disclosure relates generally to autonomous real-time generation and modification of dynamic electronic test master files. Background The electronic trial master file (eTMF) serves as a central repository for various files collected during the clinical trial. Regulatory authorities such as the Food and Drug Administration (FDA) and corresponding authorities in other countries will periodically check eTMF to ensure that clinical trials are conducted in a compliant and regulatory manner. The traditional eTMF creation method relies mainly on manual work and is labor intensive. Generally, these flows begin with defining eTMF structures. This involves generating a file plan in which the relevant file types required for the trial are summarized. The team then manually determines the appropriate documents based on the nature of the study and creates a hierarchy of fill placeholders for those documents. Such methods require a significant amount of manual intervention, including printing and scanning documents. Once printed and filled in manually, the document is scanned back into the system, reviewed and then placed in the correct position in the eTMF folder structure. This process is repeated for each document, resulting in a workflow that is extremely time consuming and inefficient. As a further example, as regulations and/or studies change over time (e.g., test sites are added or removed), quality control reviews need to be continually conducted. In conventional approaches, a file plan is created based on an industry standard reference model, such as the clinical data interchange standard alliance (CDISC) trial master file reference model, which is currently standard in the art ("TMF reference model"). The program specifies the structure and type of document required, which is then manually entered into eTMF. Despite advances in digital technology, a large number of sheets are still used because documents are typically printed, filled in manually, and then scanned back into the system. Thus, in general, the current eTMF management state is characterized by manual operations that require a significant amount of effort to review, sort, and properly archive documents. Disclosure of Invention In view of the above-mentioned shortcomings of the conventional methods, a technical solution must be provided to solve the technical problem, i.e., to provide a more efficient and automated solution to simplify eTMF the procedure and to improve the efficiency of clinical trial document management. The disclosed embodiments provide a system, computer-implemented method, and computer-readable medium for autonomously generating and modifying a dynamic hierarchical file structure of an electronic test master file (eTMF) in real-time, the method comprising receiving, by an event processor, event messages from a messaging system that integrates a plurality of applications configured to automatically generate the messages in real-time in response to the events. Each event corresponds to a user interaction with one of the applications at the first site via a user interface of the computer system based on an activity associated with the clinical trial, and each event message corresponding to each of said user interactions contains metadata related to the respective activity. The method further includes determining, by the event processor, one or more hierarchical file structure placeholders associated with the respective activity for each of the event messages based on the metadata of each of the event messages. The method further includes automatically modifying, by the event handler, the hierarchical file structure in real-time to include the one or more hierarchical file structure placeholders. The method further includes storing one or more documents received from the computer system of the first site in the one or more hierarchical file structure placeholders. Embodiments may include one or more of the following features. Metadata associated with a respective activity may include one or more of a site identifier associated with a site, a milestone identifier corresponding to the activity, and a role designation for a user associated with the activity. The method may include notifying one or more users of the first site in real time as placeholders are created in the hierarchical file structure. The method may include automatically verifying one or more documents received from one computer system according to a predefined format or compliance criteria before storing the one or more documents received from the computer system in the hierarchical file structure placeholder. Determining, by the event handler, 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 types