Clinical Research Billing Compliance

Ensuring the appropriate billing of clinical research services is a multifaceted process and requires the support and participation of Principal Investigators, nurse coordinators, administrative offices, and sophisticated electronic systems. As illustrated above, a successful clinical research billing process includes a number of activities and starts well before the research study is initiated. Some of these activities may be linear in execution but others are not. For example, negotiating a clinical trial agreement (CTA), negotiating a budget, and seeking IRB approval of a protocol/Informed Consent Form (ICF) may, and often do, occur simultaneously.

This electronic manual was created to support those individuals and entities with a role and responsibility in the clinical research billing process and to ensure proper billing of services to the sponsor of the study, study subject’s insurance provider or the study subject. The information contained in this manual provides users a better understanding of the complete process but also provides “how to” steps for completing certain functions. Questions and/or suggestions relating to the manual should be sent to Catherine “Cassie” Cruz-Montes at catherine.cruz-montes@yale.edu.