Clinical Trials at USA
The Clinical Trials Office (CTO) is a USA Health systemwide office providing support
to investigators conducting clinical studies, including industry-sponsored, investigator-initiated,
and federally funded trials.
1. Feasibility assessments - Evaluation of a study with respect to available clinical
resources, patient population and financial feasibility.
2. Budgeting - Following USA Health policies, the CTO Budget Team will estimate all costs associated with a clinical trial and negotiate with the sponsor.
3. Contracting - We work closely with the USA legal team to negotiate contract terms for a clinical study.
4. Research Coordinators - The CTO oversees a group of research coordinators whose budgeted effort can be assigned to specific clinical studies.
5. Coverage Analysis - Coverage analysis is vital for billing compliance and is required for all clinical trials at USA. The CTO works with a third-party to obtain all applicable coverage analysis.
6. Charge Segregation - CTO oversees active trials to ensure that patient charges are being segregated correctly.
7. Sponsor Invoices and Receivables - The CTO invoices sponsors based on the negotiated budget and ensured payments are received.
8. Regulatory support - Two regulatory coordinators in the CTO manage all regulatory aspects of a trial, including IRB submission, negotiating informed consent language, completing FDA-required documents, clinicaltrials.gov registration, training requirements, etc.
The CTO oversees all clinical trials in the USA Health system. Any investigators proposing to conduct a clinical trial must first consult with the CTO. This oversight includes prospective studies with an intervention and those that require billable items to be charged to the research study.
To submit your study to the CTO, email the Director of the Clinical Trials Office, Stefanie White, at firstname.lastname@example.org.
For more information about clinical trials, please visit the Office of Research Compliance.