Honoraria - Leveraging Enhanced EDC Integrated CTMS
Functions
Issues surrounding honoraria paid in clinical studies increase exponentially with the size and scope of the research. Payments for screening, enrollment, testing, data collection et cetera that are manageable in a small feasibility study or Investigator Initiated Trial, become a time-consuming, high overhead task with dozens or hundreds of sites and an equal or greater number of investigators and patients. In addition, anti-kickback statutes and their interpretation by the Department of Justice and Office of Inspector General dictate that sponsor organizations remain in the safe-harbor of paying only for work performed. From the investigative site's perspective, they wish to be reimbursed at the earliest available opportunity for the expenses they have incurred in participating in the research, and may be intolerant of delays associated with ensuring regulatory compliance.
This paper discusses two approaches taken by clientele of MedNet Solutions in leveraging enhanced electronic data capture (EDC) to reduce the burden surrounding honoraria compliance and increase investigative site satisfaction - in effect, leveraging the EDC system to provide AutoHonoraria CTMS benefits.
Background on system characteristics enabling AutoHonoraria vs. traditional methodologies
Workflow processes in making honoraria payments in clinical studies/initiatives are essentially the same irrespective of the system used. In the simplest rendering, the process may be described as activity>validation of activity>payment generation. A simple concept rapidly becomes complex within the clinical world as compliance issues, SOPs, GCPs and other elements exert influence on the processes. A traditional methodology such as paper CRFs or fax submissions adds a number of steps within each process element, as can be seen in figure 1. Each step in and of itself is not particularly difficult or complex, but the process when taken as a whole can certainly be so - in this example , the whole is greater than the sum of its parts, especially when a manual process necessarily involves multiple personnel.
Figure 1. Process steps in traditional methodology
(Click image for larger image)
The steps outlined in figure 1 are essentially manual processes, and as such are 1) time-consuming, 2) prone to human error/mis-keying and 3) relatively inefficient, and thus present compliance and site satisfaction issues.
Utilization of enhanced EDC can, as an essential product of operation, address all three problem areas - rapid real-time processing, removal of human interaction in many instances, and significantly improved efficiency. Concomitantly, compliance is enhanced through a reliable replicable process with automatically generated audit trails and on-demand visibility/reporting, and site satisfaction increased through timeliness of reimbursement and reduction in error rates.
© Timothy Pratt 2005
