Electronic binder system (ebinder) for processing source data to EDC systems

A method for automatically and seamlessly converting clinical trial source data into key-value structured datasets and processing it into Electronic Data Capture datasets, wherein said clinical trial source data comprises site source file images, electronic medical records, and electronic patient-reported outcomes for use in conducting a clinical trial, the method comprising:

• a. defining a file structure for storing source data in an eBinder system;
• b. extracting source data from a plurality of sources;
• c. encrypting said source data using an encryption algorithm;
• d. masking Patient Identifiable Information;
• e. verifying the masking of said Patient Identifiable Information;
• f. converting said source file images into machine readable plain text using Optical Character Recognition technology;
• g. correcting any formatting or spelling errors in said machine readable plain text using a generative pretrained transformer;
• h. transforming said machine readable plain text into tabulated machine readable text using a generative pretrained transformer;
• i. converting said tabulated machine readable plain text into machine understandable plain text using a generative pretrained transformer,
• j. populating electronic Case Report Forms using said machine understandable plain text;
• k. displaying said populated electronic Case Report Forms and associated source data side-by-side;
• and
• l. verifying said electronic Case Report Forms against said associated source data.

A computerized system for automatically and seamlessly converting clinical trial source data into a plurality of key-value structured datasets and processing it into Electronic Data Capture datasets and electronic Case Report Forms, wherein said source data comprises site source file images, electronic medical records, and electronic patient-reported outcomes, all relating to the subjects of a clinical trial, the system comprising:

• a. a processor;
• b. an eBinder system in electronic communication with a secure web application for receiving source data from clinical trial studies;
• c. an eBinder database for storing data;
• d. an encryption module for encrypting said source documents;
• e. a Patient Identifiable Information masking module for masking source data;
• f. an Optical Character Recognition module for converting source file images into machine readable plain text in the JavaScript Object Notation format;
• g. a HyperText Markup Language module for converting said plain text in the JavaScript Object Notation format into tabulated machine readable plain text in the HyperText Markup Language format;
• h. a generative pretrained transformer module for converting said machine readable plain text in the HyperText Markup Language format into machine understandable plain text;
• i. a generative pretrained transformer module for populating source data into electronic Case Reporting Forms;
• j. a Source Data Verification module for displaying source data and associated converted data side-by-side for conducting remote Source Data Verification;
• and
• k. a viewing module for remotely accessing source data for regulatory review or auditing purposes.

A computerized system for automatically and seamlessly converting clinical trial source data into a plurality of key-value structured datasets and processing it into Electronic Data Capture datasets and electronic Case Report Forms, wherein said source data comprises site source file images, electronic medical records, and electronic patient-reported outcomes, all relating to the subjects of a clinical trial, the system comprising:

• a. a non-transitory computer readable storage media storing computer program instructions defined by the modules of the computerized system;
• b. at least one computing unit coupled to the non-transitory computer readable storage media, the at least one computing unit configured to execute computer program instructions defined by the modules of the computerized system, the modules comprising:
• i. an encryption module for encrypting and decrypting data;
• ii. a masking module for automatically masking Patient Identifiable Information;
• iii. an Optical Character Recognition module for converting source file images into machine readable plain text;
• iv. a transposition module for converting said machine readable plain text into tabulated machine readable text;
• v. a generative pretrained transformer module for converting said tabulated machine readable plain text into machine understandable data;
• and
• vi. a generator module for generating Electronic Data Capture datasets and electronic Case Report Forms from said machine understandable data;
• c. a non-transitory computer readable storage media storing all data located on a secure, access restricted file server;
• and
• d. a web-based interface for displaying masked source data and the corresponding converted data side-by-side.