1. 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).

2. Clinical Trials at USC – Submission Basics
KC Pre-Award Submission Information:
Link:
Required Docs:
 Solicitation
 SOW
 Budget
 Any documents required by sponsor
Helpful Resources:
OnCore Submission Information:
Link:
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: