Clinical Trials at USC – Who handles budgeting and contracting? If you are submitting: Submit to Contract handled by Budget developed by Medicare Coverage Analysis needed from CTO? Industry sponsored trial that will use health system resources OnCore CTO Yes Non-industry sponsored trial that will use health system resources OnCore and KC DCG CTO and Department Non-sponsored trial (e.g., internally funded) that will use health system resources N/A Department Any other sponsored research KC No Note: KC=Kuali Coeus, DCG = Dept. Contracts and Grants, CTO = Clinical Trials Office, MCA = Medicare Coverage Analysis, OnCore = Clinical Trials Management System, Health System Resources = Any resource that has to be obtained from the Keck Medicine of USC (e.g., imaging, lab tests, clinical space, pharmacy, infusion services).

Clinical Trials at USC – Submission Basics KC Pre-Award Submission Information: Link: https://kc.usc.edu/kc-prd/portal.do Required Docs:  Solicitation  SOW  Budget  Any documents required by sponsor Helpful Resources: https://research.usc.edu/files/2014/07/Starting-a-Proposal.pdf OnCore Submission Information: Link: https://calv-oncore.med.usc.edu/login/ Required Docs:  Word Version of CTA or Work Order  Protocol  Investigator Brochure  Lab/Pharmacy Manual  Sponsor Budget  Sponsor Proposed ICF  CTU Services Request Form (If available)  Ancillary Services Agreements (If applicable)  IND Application/CMS Letter (if applicable)  CIC Checklist (If available) Helpful Resources: Ask CTO for the “Essential Documents and Information Guidance Document” NOTE: Basic info f More info on starting a clinical trial at USC: https://oprs.usc.edu/hsirb/startup/