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Automated reporting of payments made to patients for their participation in a clinical study in a blinded manner to the sponsor of the clinical study

a technology of automatic reporting and clinical study participation, applied in the field of automatic reporting of clinical study participation payments to patients in blinded manner to the sponsor of the clinical study, can solve the problems of inability to reproduce the compensation of cash and checks, and the difficulty of obtaining checks,

Inactive Publication Date: 2014-08-21
GREENPHIRE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent describes a method for reporting payments made to patients for participating in a clinical study in a blinded manner to the sponsor of the study. The method involves receiving payment requests from investigative sites and processing them to approve payments that meet predefined guidelines. The application generates blinded payment reports that include the de-identified subject ID for each approved payment and the associated patient ID information. The patient can use their assigned debit card to access the payment amount. The technical effect of this patent is to provide a secure and efficient way to manage payments in clinical studies while maintaining patient privacy.

Problems solved by technology

Typically, this is an expense borne by the sponsor of the study and administered by the study coordinators who interact with the subjects in a trial, and must adhere to the study-specific protocols that govern the study and that detail the structure of patient compensation.
Both cash and checks have disadvantages within the clinical study compensation process.
Cash provides no reproducible proof of compensation.
Checks often take weeks to be issued and require a subject to have a bank account or incur check cashing fees.
In addition, it oftentimes proves to be difficult, if not impossible, to provide records to the sponsor or other parties associated with the execution of an ongoing clinical study of the compensation paid to the subjects for the purposes of auditing or reconciliation, without revealing sensitive information which the sponsor should not be exposed to.

Method used

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  • Automated reporting of payments made to patients for their participation in a clinical study in a blinded manner to the sponsor of the clinical study
  • Automated reporting of payments made to patients for their participation in a clinical study in a blinded manner to the sponsor of the clinical study
  • Automated reporting of payments made to patients for their participation in a clinical study in a blinded manner to the sponsor of the clinical study

Examples

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Embodiment Construction

[0016]Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention.

I. Overview

[0017]Developments in payment technology has allowed for the transfer of funds to be provided in a real-time manner via a prepaid debit card, thereby providing the same access to compensation as historic payment methods, while establishing central electronic based records detailing the time, amount, and parties involved in a compensation transaction.

[0018]Greenphire LLC (Greenphire), located in King of Prussia, Pa., is a clinical trials technology company that has created an application which allows parties within the clinical study process to utilize the benefits of the prepaid debit card payment technology to provide subject stipend / reimbursement payment. The process in which Greenphire allows for payment approvals and provides reporting of subject compensation provides an innovative instrument in which study participant compensation information ...

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Abstract

An automated method and computer program product are provided for reporting payments made to patients for their participation in a clinical study in a blinded manner to the sponsor of the clinical study. The clinical study has a plurality of investigative sites which perform activities in accordance with the protocol of the clinical study. Each patient has patient ID information and is assigned a subject ID that de-identifies the patient. Payment requests are received at a software application from the investigative sites associated with patient activity. The software application includes for each patient that is participating in the clinical study, the patient ID information, and the de-identified subject ID. The payment requests are associated with the patient ID information. The payment requests are processed at the software application, and payments that conform to predefined compensation guidelines for the clinical study are approved. The software application generates blinded payment reports for electronic delivery to the sponsor. The payment reports show at least the de-identified subject ID for each approved payment, the payment amounts for each approved payment, and a date associated with the payment.

Description

CROSS REFERENCE TO RELATED APPLICATION[0001]This application is a continuation of copending U.S. patent application Ser. No. 13 / 170,899 filed Jun. 28, 2011, which is incorporated herein by reference.[0002]This application claims the benefit of U.S. Provisional Patent Application No. 61 / 360,219 filed Jun. 30, 2010, which is incorporated in its entirety herein.BACKGROUND OF THE INVENTION[0003]Pharmaceutical, medical device and biotechnology (sponsor) companies that wish to bring a product to market in the United States must have their product undergo Food and Drug Administration (FDA) reviewed clinical studies. The purpose of these studies includes testing the efficacy and safety of products on human subjects (also, referred to herein as patients or study participants). Since these studies address the medical status and health aspects of the subjects, the Health Insurance Portability and Accountability Act of 1996 (HIPPA) pertains to the use and disclosure of the subjects' personal he...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): G06Q50/22G06Q10/10
CPCG06Q10/10G06Q50/22
Inventor SAMAR, JOHN P.WHITAKER, SAMUEL J.
Owner GREENPHIRE
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