US 12,217,835 B2Granted

Systems and methods for hashing-based assessment of electronic clinical trial outcomes

AssigneeeResearchTechnology, Inc.

InventorUdit Adhikari

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Abstract

The present disclosure is related to systems and methods for hashing-based assessment of electronic clinical trial outcomes. Such systems and methods may advantageously enable secure, rapid, efficient, and cost-effective reuse of pre-built eCOA assessments for clinical trials. In an aspect, the present disclosure provides a computer-implemented method for validation of an electronic clinical trial outcome assessment (eCOA), comprising: (a) obtaining an assessment of an eCOA, the assessment comprising a plurality of files generated by performing a first validation of the eCOA; (b) obtaining a first hash value associated with the assessment of the eCOA, the first hash value generated by hashing the plurality of files of the assessment of the eCOA; (c) hashing the plurality of files of the assessment of the eCOA to generate a second hash value; and (d) validating the eCOA when the second hash value is equal to the first hash value.

Claims13

Dependent claims

A computer-implemented method for transmitting an assessment of an electronic clinical trial outcome assessment (eCOA) software to a user, comprising:

(a) accessing, by an interface of a mobile platform, a database to obtain plural pre-built library folders from the database, wherein each library folder comprises one or more files, wherein each library folder has an associated hash value;
(b) compiling, by the interface, the plural pre-built library folders into a project to be deployed on the mobile platform;
(c) generating, by the interface for each library folder of plural library folders of an eCOA, a first hash value by applying a hashing algorithm to the one or more files of a respective library folder of the project in a specified order;
(d) generating, by the interface, a second hash value by applying a hashing algorithm to the plural folders of an eCOA assessment including the one or more files of each library folder;
(e) storing, by the interface, the first hash value and the second hash value in memory of the mobile platform;
(e) comparing, by the interface:
the first hash value of each library folder of the project to be deployed on the mobile platform to a pre-build first hash value of the library folder that was generated prior to the project being deployed to the mobile platform;
and
the second hash value to a standardized hash value of the eCOA that was generated prior to the project being deployed to the mobile platform;
(f) analyzing, by the interface, features of the electronically formatted to determine a significance of changes between the eCOA and a non-electronic clinical outcome assessment stored in memory;
(g) validating, by the interface, the plural files of the eCOA, when the first hash value is equal to the pre-built first hash value, the second hash value is equal to the standardized hash value, and the significance of changes meets a specified threshold;
and
(h) deploying, by the interface to the mobile platform, the eCOA for use on the mobile platform.

10 more elements

A mobile device for validating an electronic clinical trial outcome assessment (eCOA), the mobile device comprising:

a processor configured to execute program code for generating an application program interface, the application program interface causing the processor to:
(i) receive a request for deploying an eCOA to the mobile device;
(ii) access a database over a network to obtain plural plural pre-built library folders, each library folder including one or more files, and each library folder has an associated hash value;
(iii) compile the plural pre-built library folders into a project to be deployed on the mobile platform;
(iii) generate a first hash value for each library folder of the plural library folders of the eCOA by applying a hashing algorithm to the one or more files of a respective library folder of the project in a specified order;
(iv) generate a second hash value by applying a hashing algorithm to the plural folders of an eCOA including the one or more files of each library folder;
(v) storing, by the interface, the first hash value and the second hash value in memory of the mobile platform;
(vi) compare the first hash value of each library folder of the project to be deployed on the mobile platform to a pre-build first hash value of the library folder that was generated prior to the project being deployed to the mobile platform;
(vii) compare the second hash value to a standardized hash value of the eCOA that was generated prior to the project being deployed to the mobile platform;
(viii) analyzing, by the interface, features of the electronically formatted to determine a significance of changes between the eCOA and a non-electronic clinical outcome assessment stored in memory;
(ix) validate the plural files of the eCOA, when first hash value is equal to the pre-built first hash value, the second hash value is equal to the first standardized hash value, and the significance of the eCOA meets a specified threshold;
and
(x) deploy the eCOA for to the processor on the mobile platform.

10 more elements

Dependencies are inferred from the claim text.

Facts

Application: 16/830,903Filed 26 Mar 2020 · us provisional application
Priority: 18 Mar 2020
Published: US 2021/0295956 A123 Sep 2021
Granted: 4 Feb 2025
Term ends: Not estimatedThe source records don’t support an estimate.

Classification9 codes

G16H 10/20
ICT specially adapted for the handling or processing of patient-related medical or healthcare data: for electronic clinical trials or questionnaires
G06F 11/3688
Test management: for test execution, e.g. scheduling of test suites
G06F 16/1873
File system types: versioning file systems, temporal file systems, e.g. file system supporting different historic versions of files
G06F 16/9027
Indexing; Data structures therefor; Storage structures: trees

Family

Application62/991,279Us provisional application · filed 18 Mar 2020
US 2021/0295956 A1Pre-grant publication · published 23 Sep 2021
US 12,217,835 B2This patent

From the US filing history. Foreign family members aren’t listed.

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