USC Clinical Trials Office

Serving patients, researchers and sponsors by expediting clinical trials for novel and promising therapies

Research Order Forms – A Promissory Note to Pay….What Does this Mean?

By Cynthia Morales and Nora Turrey

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When completed, the Research Order Form (ROF) serves as a clinical order and defines which services are billable and payable by the research study (i.e. the Sponsor). Providers will access the ROF in the medical record and bill all charges indicated on the ROF to research. Billing the Sponsor is a function managed by the CTO Post-Award team.

Tests and procedures included in the sponsor’s protocol do not automatically make routine patient care costs billable to the study sponsor; Medicare Coverage Analysis and negotiations with the study sponsor determine such billing arrangements.

Always refer to the Medicare Coverage Analysis document along with the ROF to confirm budget and billing requirements. These documents can be found within TRUE (www.uscnorris.com/CRO) for studies submitted to the CTO prior to April 1, 2016. For Studies submitted to the CTO after April 1, 2016, please refer to OnCore to review the ROF and MCA.

Always check True/OnCore to ensure that the most current ROF is utilized to help avoid potential billing discrepancies.

If the study team inappropriately completes the research order form and the provider is unable to bill insurance, the research study account will be charged for services provided to their participant.