# US 12,217,835 B2 · Systems and methods for hashing-based assessment of electronic clinical trial outcomes

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- Number: US 12,217,835 B2
- Document ID: US12217835B2
- Status: Granted
- Kind: B2
- Application number: 16/830,903
- Filed: 2020-03-26
- Published: 2021-09-23
- Granted: 2025-02-04
- Earliest claimed: 2020-03-18
- Assignees: eResearchTechnology, Inc.
- Applicants: eResearchTechnology, Inc.
- Inventors: Udit Adhikari
- Web page: https://patentgrep.com/patent/US12217835B2

## CPC

- G16H 10/20: for electronic clinical trials or questionnaires
- G06F 11/3688: {for test execution, e.g. scheduling of test suites}
- G06F 16/1873: {Versioning file systems, temporal file systems, e.g. file system supporting different historic versions of files}
- G06F 16/9027: {Trees}
- H04L 9/3239: {involving non-keyed hash functions, e.g. modification detection codes [MDCs], MD5, SHA or RIPEMD}
- H04L 9/3242: {involving keyed hash functions, e.g. message authentication codes [MACs], CBC-MAC or HMAC}
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)
- H04L: TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION (arrangements common to telegraphic and telephonic communication H04M)

## 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.

## Claims

### Claim 1

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.

### Claim 2 (depends on 1)

The method of claim 1, wherein at least one of the first hashing algorithm and the second hashing algorithm is a deterministic algorithm.

### Claim 3 (depends on 2)

The method of claim 2, wherein the deterministic algorithm is based on an order in which at least one of the first hashing algorithm and the second hashing algorithm is applied to the plurality of files of the assessment of the eCOA software.

### Claim 4 (depends on 1)

The method of claim 1, wherein at least one of the first hashing algorithm and the second hashing algorithm is a message authentication code (MAC) algorithm.

### Claim 5 (depends on 1)

The method of claim 1, wherein at least one of the first hashing algorithm and the second hashing algorithm is MD5.

### Claim 6 (depends on 1)

The method of claim 1, further comprising:
generating an indication that the eCOA software has been validated.

### Claim 7 (depends on 1)

The method of claim 1, further comprising:
generating an indication that the eCOA software is not valid, if the second hash value is not equal to the standardized hash value.

### Claim 8

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.

### Claim 9 (depends on 8)

The mobile device of claim 8, wherein at least one of the first hashing algorithm and the second hashing algorithm is a deterministic algorithm.

### Claim 10 (depends on 9)

The computer system of claim 9, wherein the deterministic algorithm is based on an order in which the hashing algorithm is applied to the plurality of files of the assessment of the eCOA software.

### Claim 11 (depends on 8)

The mobile device of claim 8, wherein at least one of the first hashing algorithm the second hashing algorithm is a message authentication code (MAC) algorithm.

### Claim 12 (depends on 8)

The computer system of claim 8, wherein at least one of the first hashing algorithm and the second hashing algorithm is MD5.

### Claim 13 (depends on 8)

The mobile device of claim 8, wherein the further configured to generate an indication that the eCOA software is not valid, if the second hash value is not equal to the first hash value.