Systems and methods for managing clinical research
Inventors
VIRKAR, Hemant V. • McCartan, Thomas • CARROLL, Stacy • CLINE, Matthew • GADBOIS, Richard
Assignees
Publication Number
US-11049596-B2
Publication Date
2021-06-29
Expiration Date
2038-11-16
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Abstract
The disclosure relates to a computer system for managing medical research data. The computer system may include a network interface connecting the computer system a plurality of data providers. The computer system may include a plurality of data adaptors, each data adaptor configured to communicate with one or more of the data providers to obtain data in a respective data format. The computer system may include a data processor configured to control processing resources based on a volume of data obtained from the plurality of data providers. The computer system may include a plurality of data converters executed by the processing resources, each data converter configured to convert the obtained data from a corresponding data adaptor in the respective data format to a common data format including first metadata based on the obtained data. The computer system may include a data repository for storing data in the common data format.
Core Innovation
The invention provides a computer system and associated methods for managing medical research data, specifically designed to address the challenge of integrating and processing diverse datasets originating from a variety of clinical and real-world data providers. The system utilizes a set of modular data adaptors, each configured to communicate with one or more data providers and obtain data in their respective formats and interchange mechanisms. Once obtained, data converters process this information into a common data format, which is labeled with metadata linking the records to specific medical research participants.
The system further includes a data repository to store the medical research records as unstructured raw data, retaining transaction metadata such as timing, content type, and data source. Data pipelines are employed to parse these records and publish the data into fields of a structured database, implementing incremental processing and supporting business or analysis rules. Each field within the structured database is tagged with display control metadata. This enables the management portal to dynamically determine which data fields to display, hide, or mask to users based on their role and associated metadata tags.
The problem being addressed is the difficulty in managing large volumes of medical research data collected in varied formats and schemas, compounded by privacy and regulatory requirements for sensitive medical information. Existing systems are not compatible, making it difficult for researchers to access complete datasets. The invention solves these issues by enabling seamless ingestion, transformation, storage, and access controls across heterogeneous data sources, maintaining auditability and role-based security for each data field presented in reports and dashboards.
Claims Coverage
There are three independent claims in this patent, each introducing distinct inventive features for computer systems and methods for managing and displaying clinical research data.
System with data adaptors, converters, repository and role-based access control
A computer system comprises: - A network interface connecting to multiple data providers offering clinical and real-world data in diverse schemas and formats. - Multiple data adaptors, each obtaining data from providers in their respective formats. - Data converters executed by processing resources to transform data into a common data format, labeled with first metadata associating the data to research participants. - A data repository for storing unstructured raw data (medical research records) including transaction metadata (timing, content type, source), enabling each record to remain independently accessible through its metadata schema, even if data formats change. - At least one data pipeline configured to query the repository, parse unstructured data using transaction metadata, and publish the resulting data into a structured database, tagging fields with display control metadata. - A management portal to assign user roles, process display requests, and determine for each field in a report whether to show, hide, or mask it, based on user role and display control metadata.
Method for multi-format data access control using adaptors, pipelines, and display metadata
A method includes: - Receiving clinical and real-world data in multiple formats from a plurality of data providers. - Obtaining the data via a plurality of data adaptors. - Converting the data from each adaptor into a common format labeled with metadata associating it to research participants. - Storing the data as unstructured raw data in a repository, where each record contains transaction metadata (timing, content type, source) supporting independent access even if data formats change. - Querying the repository with at least one data pipeline to parse unstructured data, publish it into fields of a structured database, and tag each field with display control metadata. - Assigning user roles, handling display requests, and determining for each field whether to display, hide, or mask content based on user role and display control metadata.
System with pipelines tagging fields for report display based on user role and field metadata
A computer system comprises: - A network interface connecting to multiple data providers offering clinical/real-world data in multiple formats. - Multiple data adaptors for obtaining the data in their respective formats. - Multiple data converters executed by processing resources to convert data from each adaptor into a common format labeled with metadata for medical research participants. - A data repository storing all records as unstructured raw data with transaction metadata, enabling independent accessibility through unique metadata schemas. - At least one data pipeline to (i) query the repository to parse unstructured data and publish to fields of a structured database for requested report display, and (ii) tag at least one field in the structured database with display control metadata. - A management portal configured to determine user roles, receive report display requests, and for each displayed field, decide to display, hide, or mask content based on the user’s role and field’s display control metadata.
The inventive features focus on systems and methods for obtaining multi-format medical research data, transforming it into a common format with metadata, storing it as unstructured data with transaction tracking, incrementally parsing the data into a structured database, tagging fields for display control, and enabling flexible, role-based, metadata-driven access and masking for reporting and analytics.
Stated Advantages
Enables seamless integration and processing of heterogeneous medical research data from multiple incompatible data providers and formats.
Provides robust, dynamic, and modular architecture to efficiently scale processing and adapt to new data sources with minimal intervention.
Allows fine-grained, role-based access control to sensitive data fields, including dynamic masking and hiding of data to meet privacy and regulatory needs.
Ensures auditability and traceability by storing transaction metadata with each data record and maintaining independently accessible records even after schema changes.
Improves the efficiency of data processing, querying, and reporting through use of standard data formats and pipelines with metadata-based field tagging.
Documented Applications
Management of clinical research involving medical patients, including the integration, processing, and secure role-based display of clinical and real-world research data.
Tracking and auditing electronic patient-reported outcome (ePRO) questionnaires, including maintaining a full audit trail of form edits, user actions, and eligibility for honorariums.
Providing report generation, analytics, and dashboard tools for different research study roles (such as participant, physician, and study manager) with dynamic access controls.
Managing protected health information (PHI), including the storage, linking, and secure display/masking of PHI fields in compliance with privacy regulations.
Supporting familial models in research studies, allowing proxies and roles that facilitate data entry and management for families or delegates.
Processing and redacting video data collected during clinical research, including facial redaction and metadata tagging for enhanced privacy.
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