by Sonya Cato, MS, Cato Research CTMS Administrator
A key feature of Cato Research’s clinical trial management service is the administration of investigator payments. Multicenter clinical trials provide unique challenges in this area that can be managed through the use of an efficient, integrated CTMS.
During the preparation for the conduct of a clinical trial, significant time and effort are invested in the development and negotiation of clinical trial agreements with each clinical site participating in the study. Each agreement includes a customized, detailed site budget that itemizes the activities for which the site will be compensated for its implementation of the study protocol. Site budgets frequently include compensation for start-up activities, subject visits, specialized subject procedures, screen-failed subjects, and special equipment costs. It is a normal practice for clinical sites to be compensated for a subject visit only after the data for that visit have been monitored by a clinical research associate. In addition to the site budget, the clinical trial agreement specifies the frequency in which payments will be made to the clinical site.
Cato Research uses BioClinica’s CTMS as a tool for managing site payments. Within the payments module, Cato Research can design payment programs for clinical sites and calculate the actual payment due based on negotiated contracts and verifiable clinical activity. Site payment milestones are tracked as they occur, a process that queues them for inclusion in the next invoice generated. Subject, procedure, and monitoring data are uploaded automatically to the CTMS through integration with the electronic data capture system, allowing queuing of payments for subject-related information to occur with minimal data entry by project management.
The CTMS allows invoices to be generated independently for each clinical site according to the contracted payment schedule. Draft invoices generated from the CTMS are reviewed internally and modified as necessary to accurately reflect the activities for which the site can be reimbursed. An important feature of the CTMS is its ability to defer the full or partial payment of an invoice item to a later invoice. For example, if a subject visit has occurred and been monitored, but the electronic case report form for that visit has numerous outstanding edit checks, the project manager may choose to defer payment for that visit until the issues have been resolved. After the invoice has been approved, the CTMS generates an invoice that contains all the information needed to issue the payment. Once paid, the invoice is logged as completed in the CTMS, along with relevant payment details.
Using the CTMS, project management can track payments made to date against total study budget at study, site, and subject levels and generate payments for investigators based on the contract details for payment. The process aligned with the CTMS provides study managers and project stakeholders with real time data that enables accurate and timely payments to the investigators.