Automated method of reporting payments made to patients for their participation in a clinical study in a blinded manner to the sponsor of the clinical study
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.
1. An automated method of 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 having a plurality of investigative sites which perform activities in accordance with the protocol of the clinical study, each patient having patient ID information and being assigned a subject ID that de-identifies the patient, the method comprising:
(a) receiving payment requests at a software application executing on one or more computer processors from the investigative sites associated with patient activity, the software application executing on the one or more computer processors including for each patient that is participating in the clinical study, the patient ID information, and the de-identified subject ID, the payment requests being associated with the patient ID information, the payment requests being requests to make payments to patients for their participation in the clinical study, and wherein approved payment requests are reported on blinded payment reports;
(b) processing the payment requests at the software application executing on the one or more computer processors, and approving payments that conform to activities performed in accordance with the protocol of the clinical study and in line with regulatory guidelines and approved budgets for the clinical study, the approved payments being payments made to patients for their participation in the clinical study; and
(c) generating by the software application executing on the one or more computer processors the blinded payment reports for electronic delivery to the sponsor, each blinded payment report showing at least:
(i) the de-identified subject ID for each approved payment,
(ii) the payment amounts for each approved payment, and
(iii) date associated with each approved payment,
each blinded payment report including approved payments made for a plurality of de-identified subject ID's, wherein the approved payments are payments made to patients for their participation in the clinical study.
2. The method of claim 1 wherein the participation includes at least one of patient screening, or patient enrollment.
3. The method of claim 1 wherein the participation includes consumption or use of an investigational product associated with the clinical study.
4. The method of claim 1 wherein the date associated with the payment is the date of patient activity, or the date of the payment request, or the date of the payment approval.
5. The method of claim 1 wherein selected patients are assigned to their own respective debit cards, each debit card having a balance, wherein step (b) further comprises updating the balance of the debit cards by the software application executing on the one or more computer processors for the approved payments.
6. The method of claim 1 wherein step (b) further comprises queuing payment requests via the software application for electronic review by the sponsor, and approving payments via electronic authorization by the sponsor.
7. A computer program product 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 having a plurality of investigative sites which perform activities in accordance with the protocol of the clinical study, each patient having patient ID information and being assigned a subject ID that de-identifies the patient, the computer program product comprising a non-transitory computer-readable media encoded with instructions for execution by one or more computer processors to perform a method comprising:
(a) receiving payment requests at a software application executing on the one or more computer processors from the investigative sites associated with patient activity, the software application executing on the one or more processors including for each patient that is participating in the clinical study, the patient ID information, and the de-identified subject ID, the payment requests being associated with the patient ID information, the payment requests being requests to make payments to patients for their participation in the clinical study, and wherein approved payment requests are reported on blinded payment reports;
(b) processing the payment requests at the software application executing on the one or more computer processors, and approving payments that conform to activities performed in accordance with the protocol of the clinical study and in line with regulatory guidelines and approved budgets for the clinical study, the approved payments being payments made to patients for their participation in the clinical study; and
(c) generating by the software application executing on the one or more computer processors the blinded payment reports for electronic delivery to the sponsor, each blinded payment report showing at least:
(i) the de-identified subject ID for each approved payment,
(ii) the payment amounts for each approved payment, and
(iii) date associated with each approved payment,
each blinded payment report including approved payments made for a plurality of de-identified subject ID's, wherein the approved payments are payments made to patients for their participation in the clinical study.
8. The computer program product of claim 7 wherein the participation includes at least one of patient screening, or patient enrollment.
9. The computer program product of claim 7 wherein the participation includes consumption or use of an investigational product associated with the clinical study.
10. The computer program product of claim 7 wherein the date associated with the payment is the date of patient activity, or the date of the payment request, or the date of the payment approval.
11. The computer program product of claim 7 wherein selected patients are assigned to their own respective debit cards, each debit card having a balance, wherein step (b) further comprises updating the balance of the debit cards by the software application executing on the one or more computer processors for the approved payments.
12. The computer program product of claim 7 wherein step (b) further comprises queuing payment requests via the software application for electronic review by the sponsor, and approving payments via electronic authorization by the sponsor.