# US 2013/0159014 A1 · System and Method for Management of Research Subject or Patient Events for Clinical Research Trials

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- Number: US 2013/0159014 A1
- Document ID: US20130159014A1
- Status: Published application
- Kind: A1
- Application number: 13/769,685
- Filed: 2013-02-18
- Published: 2013-06-20
- Earliest claimed: 2008-08-06
- Assignees: I the Patient Recruiting Agency, LLC
- Inventors: Todd B. Sanders; Lance D. Nickens; Carl T. Wibbenmeyer
- Web page: https://patentgrep.com/patent/US20130159014A1

## CPC

- G16H 70/20: relating to practices or guidelines
- G06F 7/00: Methods or arrangements for processing data by operating upon the order or content of the data handled (logic circuits H03K19/00)
- G06F 17/00: Digital computing or data processing equipment or methods, specially adapted for specific functions (information retrieval, database structures or file system structures therefor G06F16/00)
- G06Q 10/10: Office automation; Time management
- G16H 10/20: for electronic clinical trials or questionnaires
- 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)
- G06Q: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR

## Abstract

A system and method for managing clinical research trials is disclosed. The system and method may include a centralized secure database with information on clinical research trial participants, clinical research trial events, investigator and administrator inputs, and communication of participants, investigators and administrators. In one embodiment, the system and method allows investigators to contact participants without disclosing confidential contact information of the participants to the investigators by storing health information and contact information in separate databases. In one embodiment, administrators may access clinical research trial information through a secure web portal.

## Claims

### Claim 1

A system for managing research subject or patient events for clinical research trials comprising:
a centralized secure database;
an administrator database communicatively connected to said centralized secure database;
one or more investigator databases communicatively connected to said centralized secure database whereby information residing in said one or more investigator databases is periodically transferred to said centralized secure database;
a high-clearance interface for accessing said centralized secure database;
an administrator interface for accessing said administrator database;
an investigator interface for accessing said one or more investigator databases; and
at least one communication gateway.

### Claim 2 (depends on 1)

The system of claim 1 wherein said investigator interface assists investigators with the implementation of a clinical research trial protocol.

### Claim 3 (depends on 2)

The system of claim 2 wherein said assistance includes providing an automated scheduling and data recording tool for tracking the progress of participants in a clinical research trial.

### Claim 4 (depends on 1)

The system of claim 1 wherein said administrator interface allows administrators to monitor and analyze clinical research trial data and communicate with investigators via said at least one communication gateway.

### Claim 5 (depends on 1)

The system of claim 1 wherein said investigator interface provides prompts to investigators and/or participants.

### Claim 6 (depends on 1)

The System of claim 1 wherein information residing in said administrator database is periodically transferred to said centralized secure database.

### Claim 7

A method for managing research subject or patient events for clinical research trials comprising:
entering clinical research trial configuration information into a centralized secure database through a high-clearance interface;
entering clinical research trial data into one or more investigator databases through an investigator interface;
periodically transferring said clinical research trial data residing in said one or more investigator databases to said centralized secure database and periodically transferring limited datasets from said centralized secure database to an administrator database and to said one or more investigator databases;
monitoring and analyzing said limited datasets in said administrator database with an administrator interface;
providing prompts to investigators and/or participants through at least one communication gateway; and
recording said prompts in said centralized secure database.

### Claim 8 (depends on 7)

The method of claim 7 wherein said providing of prompts includes initiating prompts with said administrator interface.

### Claim 9 (depends on 7)

The method of claim 7 further comprising tracking the progress of participants in a clinical research trial with an automated scheduling and data recording tool that is accessible through said investigator interface.

### Claim 10 (depends on 7)

The method of claim 7 further comprising recording, via said investigator interface, the reasons why prospective participants do or do not qualify for participation in a clinical research trial.

### Claim 11 (depends on 7)

The method of claim 7 further comprising communicating with administrators and/or participants via said investigator interface and said at least one communication gateway.