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OCGA: Clinical Trials

Find information for submitting ePD records for Clinical Trials.

Clinical Trial Definitions

In general, a clinical trial is the testing of a drug, device or treatment on human subjects for the purpose of improving a health outcome. UC San Diego uses the following definitions for purposes of calculating indirect cost (IDC) and determining the responsible sponsored projects office (SPO):

UC Regents

The controlled, clinical testing in human subjects of investigational new drugs, devices, treatments, or diagnostics, or comparisons of approved drugs, devices, treatments, or diagnostics, to assess their safety, efficacy, benefits, costs, adverse reactions, and/or outcomes. Such studies may be conducted under an industry-developed protocol or an investigator-developed protocol.

National Institutes of Health (NIH)

A research study in which one or more human subjects are prospectively assigned1 to one or more interventions1 (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes1.

1Go to NIH's Definition of a Clinical Trial for detailed breakdown of their definition.

Other Clinical Trials Sponsored Projects Offices (SPO)

See below Clinical Trials SPO Matrix for details.

Components of a Clinical Trial EPD Submission

Clinical trials are distinct from basic research. Here are some things to consider when working on your ePD submission:

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Building Your ePD Record

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 (Abstract Tab): Provide details regarding the study and/or ePD record
  • Attachments: Upload the following, at minimum, in a single PDF document:
    1. OCGA internal budget sheet
    2. Research Plan
    3. Complete Proposal Application

Protocol / Research Plan

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.

Drug / Device

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

Budgeting and IDC

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.

Contract Negotiation Process

Clinical trial agreements often require complex and lengthy negotiation. 

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

Other Compliance Considerations

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.

Clinical Trials SPO Matrix

EPD Routing

Be sure the answer the clinical trial questions in the system so EPD 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 ePD record for completion:

Type of Clinical Trial

Funding Source

Protocol Authorship

Office of Clinical Trials Administration

(OCTA)

Industry-initiated, Industry Funded Clinical Trial Funded soley by a for-profit (industry) entity

Non-UC San Diego PI (solely)

Health Sciences Sponsored Project Pre-award Office 

(HS SPPO)

National Institutes of Health (NIH) Funded Clinical Trial

Grant Proposal Submissions Only (no Awards)

Prime NIH Award is a Grant (not a contract)

Either direct funding or flow-through

either UC San Diego PI or Non-UC San Diego PI 

Office of Contract and Grant Administration

(OCGA)

 

National Institutes of Health (NIH) Funded Clinical Trial

All Awards and Contract Proposal Submissions (no Grant Proposals)

Prime NIH Award is a Contract (not a grant)

Either direct funding or flow-through

UC San Diego PI or Non-UC San Diego PI 
Non-NIH, Federally Funded Clinical Trial

Prime federal (non-NIH) award is either grant or a contract

Either direct funding or flow-through

UC San Diego PI or Non-UC San Diego PI 
PI-initiated Clinical Trial Either direct funding or flow-through

UC San Diego PI either:

  • Soley, or
  • Jointly with a Non-UC San Diego PI*
*e.g. employee of another entity, other non-profit institution, sponsor, etc.
Sponsor-initiated, Non-Profit Funded Clinical Trial Non-profit entity (often a hospital)

 

Non-UC San Diego PI 

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