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 who work 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.
To maximize Children’s compliance efforts, Merge CTMS, a clinical trial management system, is used 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 Merge CTMS. More information on Merge CTMS is available on the CRSO Merge CTMS Web page.
StudyManager will be used to track patient enrollment, study visit activity and care event billing direction. StudyManager must be used for 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 policies at Children’s that provide guidance for research billing compliance.