Clinical Research Billing Compliance
Seattle Children’s is committed to compliance in clinical research and research patient care billing. It is the responsibility of investigators and their staff to ensure that billing for all clinical research studies occurs only as appropriate and in compliance with relevant laws, regulations and Children’s policies.
All investigators and research staff involved with studies that involve clinical services for research participants at Children’s need to be familiar with and abide by all research billing processes and policies.
The Office of Research Compliance and Education (ORCE) presents regular seminars on clinical research billing compliance as well as other compliance issues through their Fundamental Educational Seminar Series. See the Fundamentals of Clinical Research Billing Compliance presentation.
To maximize Children’s compliance efforts, StudyManager, a clinical trial management system, was initiated in 2007 to track research participant activity and create billing audit reports. All clinical research studies that involve billable research care events or a mixture of research care events and conventional care events that generate hospital charges are required to use StudyManager.
StudyManager will be used to track patient enrollment, study visit activity and care event billing direction. Utilization of StudyManager is required of all new clinical research studies at Children’s that meet the above criteria. More information on StudyManager is available on the ORCE StudyManager Web page.
There are several clinical trials management (CTM) policies at Children’s that provide guidance with regard to research billing compliance.