Clinical Trial/Research Agreements & Contracts

A clinical trial is most often used in conjunction with obtaining new drug or device approval from the U.S. Food and Drug Administration, although they can be designed with the sole purpose of collecting and analyzing data about an approved drug or device in order to contribute to medical knowledge about the treatment of a disease or medical conditions.

UC Definition 

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. This clinical trial definition is used for calculating indirect cost (IDC) Rate for PI-authored Clinical Trials.  Refer to a detailed breakdown of this definition here: UC Definition of a Clinical Trial

National Institutes of Health (NIH) Definition

Find information and links on the changes and clarifications by NIH regarding clinical trials definition and regulations.

The National Institutes of Health (NIH) launched a series of initiatives that rolled out in 2017 - 2018 to enhance the accountability and transparency of clinical research. These initiatives target key points along the whole clinical trial lifecycle from concept to reporting of results. These initiatives include:

• Clarification of the definition of clinical trials (effective January 1, 2018)
• Good Clinical Practices training for clinical trials (effective January 2017)
• Clinical trial specific funding opportunities (proposals due on or after January 25, 2018)
• New PHS Human Subjects and Clinical Trials Information form (proposals due on or after January 25, 2018)
• Single IRB for multi-site research (effective January 2018)
• ClinicalTrials.gov registration and reporting requirements (effective January 2017)

For additional information, see:

• NIH Clinical Trial Requirements for Grants and Contracts page
• NIH video Overview of New NIH Policies on Human Subjects Research and Clinical Trials.
• NIH Clinical Trials FAQs page
• NIH Clinical Trial-Specific Funding Opportunities page
• NIH Clinical Trial-Specific Review Criteria page
• NIH "Open Mike" article "4 Questions for researchers involved with Human Subjects Research"
• NIH "Open Mike" article "Continuing to Clarify the NIH Definition of a Clinical Trial"
• NIH "Open Mike" article "Be Careful to Pick the Right Funding Opportunity Announcement (FOA)"

Clinical Trial studies may be conducted under an industry-developed protocol or a principal investigator-developed protocol.

Learn about the differences between principal investigator authored (PI-authored) and industry-authored clinical trials by referring to the PI-authored vs. Industry-authored Clinical Trials Quick-Reference Guide page.

 In general, clinical trial is considered as PI-authored when the protocol is authored by:

• UC investigators within the course and scope of their University employment, or
• UC investigators within the course and scope of their University employment jointly with an employee of another entity (e.g., an employee of another non-profit institution, an employee of the industry-sponsor, etc.)

ClinicalTrials.gov – The Research Integrity and Compliance (RCI) office is responsible for ClinicalTrials.gov Registration and Reporting Requirements. Refer to Research Compliance and Integrity Resource information to learn more about the CT.gov public registry aimed at increased transparency and improved public awareness of research.

• PI-authored or Industry authored clinical trials, where a private sponsor is the prime sponsor, are subject to the clinical trial indirect cost rate of 30% on total direct costs (TDC), including the total cost of all subsites, for agreements effective July 1, 2016. Refer to table of Indirect Costs for Industry funded clinical trials.  
• Prime non-profit sponsor funded clinical trials are subject to the sponsor policy for IDC. Refer to Nonprofit Indirect Cost rate.
• Federally-funded clinical trials, including subawards, are subject to the applicable federal negotiated rate.  Refer to Federal Indirect Cost rate for Federally Funded Clinical Trials.

Read the official announcements regarding IDC rate for clinical trials:

• UCSD Health Sciences Communications 01/27/2016 (PDF)
• Office of the Vice Chancellor for Research 06/29/2016 (PDF)

Refer to the table below to determine which sponsored project office will review and process your Clinical Research/Clinical Trial proposal/award request:

HRPP/IRB

Refer to Human Research Protections Program (HRPP) for information about promoting high quality, ethical research. The HRPP serves as the advocate for the rights and welfare of persons who participate in research programs conducted by UCSD faculty, staff, and students. Refer to HRPP. 

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.

UCSD Guidance on ClinicalTrials.gov

Research Compliance and Integrity Resource information to learn more about the CT.gov public registry aimed at increased transparency and improved public awareness of research

ACTRI Recharge Rates and Contacts

UCSD Altman Clinical and Translational Research Institute

• Overview of New NIH Policies on Human Subjects Research and Clinical Trials (NIH.gov)
• NIH Clinical Trial Requirements for Grants and Contracts (NIH.gov)
• HIPAA - Health Information and Privacy Information (HHS.gov)
• Food and Drug Administration (FDA) Page on Running Clinical Trials (FDA.gov)

University of California Biomedical Research Acceleration, Integration & Development (UC BRAID) Contracting Network developed a toolkit to provide investigators with guidance that will facilitate the contracting process: 

Avoiding Investigator authored Trial Contracting Delays 

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-authored 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

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

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.

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)

Ensure budgets for industry sponsored clinical trials are prepared to include indirect costs.  Refer to Best Practices for Budgeting with Industry Sponsors. 

• • • Industry funded clinical trials: 30% of Total Direct Costs (TDC)
    • Federally funded clinical trials must use UC San Diego's federally-negotiated IDC rate
    • Refer to current IDC rates  - UC San Diego IDC Rate Chart
    • To learn more about indirect costs, refer to information Indirect Costs .

Contract Negotiation Process

Clinical trial agreements often require complex and lengthy negotiation with sponsors due to terms associated with intellectual property, publication and licensing terms.  Refer to more guidance and information about Sponsored Research Agreements with Industry.

Submit a Kuali Research record as soon as there is consideration that a clinical trial will be pursued to ensure the assigned sponsored projects office has adequate time to review, negotiate and execute a contract.