OCGA: Clinical Trials

Clinical Trial Questions

• Activity Type: Clinical Research
  • IMPORTANT: Selecting "Clinical Research" will populate required questionnaires related to Clinical Trials.
  • If the award type is a PI-Initiated Clinical Trial, the protocol should be provided/written by the PI
• Deadline Date for Internal Proposals:
  • 6 months from the date the record is created: 6 months out is the numerical equivalent to “internal” and lets your contract officer know that there is no hard deadline
• Indirect Costs (IDC):
  
  • Industry funded clinical trials: 30% of Total Direct Costs (TDC)
  • Federally funded clinical trials must use UC San Diego's federally-negotiated IDC rate
  • All other rates see the UC San Diego IDC Rate Chart
• Internal Comments: Provide details regarding the study and/or Kuali Research record
• Attachments: Upload the following, at minimum, in a single PDF document:
  1. OCGA internal budget sheet
  2. Research Plan
  3. Complete Proposal Application

This is a description of the scientific and clinical work the PI intends to perform. Clinical trials require IRB approval of the protocol.

For more information, go to UC San Diego's Human Research Protections Program (HRPP) site.

For drug or device studies, the sponsor typically provides the experimental drug or investigational device, usually at no additional charge to the patient or UC San Diego.

Investigational new drugs (IND)

The means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved

Investigational new devices (IDE)

Allows an investigational device (i.e. a device that is the subject of a clinical study) to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application to FDA

Budget Formats

Depending on sponsor, clinical trial budgets can look very different. Budgets might be based on a (1) capitated, per-patient basis or (2) include major cost categories similar to a sponsored research project.

Please work with your business office and the sponsor to develop your clinical trial budget.

Best Practice Questions

• Are your Per-Patient Costs sufficient? 
• Will coverage analysis be required? Contact OCAA for more info.
• Are you receiving enough working capital up-front to cover start up costs of the study?
• Does the budget include all the necessary items to conduct the clinical trial (e.g. applicable IRB fees)?
• Does the Schedule of Events match the Payment Schedule in the budget?
• Is there a Hold-Back Provision for the final payment? Can this be prorated if the Payment Schedule is milestone based?

Indirect Cost Rate (IDC)

• Industry funded clinical trials: 30% of Total Direct Costs (TDC)
• Federally funded clinical trials must use UC San Diego's federally-negotiated IDC rate
• All other rates see the UC San Diego IDC Rate Chart

To learn more about IDC, please visit OCGA's IDC page.

Clinical trial agreements often require complex and lengthy negotiation. 

Please submit an Kuali Research record as soon as you are notified of a project so that the the sponsored projects office can begin review.

Conflict of Interest (COI)

COI applies to clinical trials as it does to all sponsored research at UC San Diego.

For more information, go to the COI Office page.

PI Eligibility

The PI Exception process is also the same as it is for all sponsored research at UC San Diego.

For more information, go to the PI Exception page.

Office of Coverage Analysis Administration (OCAA)

Most clinical trials require a coverage analysis to determine what services are billed to insurance, billed to a sponsor, or billed directly to the patient. 

For more information, contact OCAA.

Kuali Research Routing

Be sure the answer the clinical trial questions in the system so Kuali Research can route you to the appropriate office.

Which office will I work with?

Depending on the factors in the table below, one of the following offices will review your Kuali Research record for completion:

• Office of Clinical Trials Administration (OCTA): Industry-initated, industry funded Clinical trials
• Health Sciences Sponsored Project Pre-award Office (HS SPPO): Soley NIH grant proposals
• Office of Contract and Grant Administration (OCGA): All other Clinical Trial Activity