Key elements of a successful congruency review for clinical trial agreements

DarshanTalks Podcast

In a congruency review, the primary objective is to ensure alignment across various elements in clinical research. The initial crucial step involves accurately analyzing Medicare coverage, determining designations based on National and Local Coverage Determinations. This forms the foundation for what is billed to the study sponsor and insurance. Any discrepancies at this stage can lead to downstream errors.
Following the coverage analysis, it becomes imperative to align the calendar with the protocol's schedule of events and the designated elements from the coverage analysis. Once the calendar is established, the focus shifts to the budget negotiation phase. Multiple touchpoints during budget negotiations necessitate periodic checks to confirm alignment with the calendar and coverage analysis designations.
On the contractual side, congruency revolves around matching the contract and budget provisions. This involves verifying that payment terms and the final budget in the contract align with the negotiated terms. Another critical aspect is ensuring congruency between the informed consent and the contract, specifically focusing on subject injury language. Standardized language for subject injury in both the informed consent and contract streamlines the congruency process. Deviations from these standards trigger communication between those handling the informed consent and contract to ensure alignment. This meticulous congruency review safeguards against discrepancies and ensures a seamless process in clinical research.