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Clinical Trial/Research Agreements & Contracts

Find links to information on managing proposals, agreements, policies, regulations and compliance associated with Clinical Research and Trials. Information provided here also addresses variances in different types of Clinical Trials, unique requirements from federal and industry sponsors, the offices responsible for submitting proposal and negotiating/executing agreements for Clinical Trials and use of Kuali Research for submitting proposals/awards for clinical trials.

Definitions (UC and NIH)

A study is considered a clinical trial when it contemplates 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. This clinical trial definition is used for calculating indirect cost (IDC) Rate for PI-authored Clinical Trials.

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.

National Institutes of Health (NIH) Definition:

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 outcomes.  Refer to a detailed breakdown of this definition here:  NIH's Definition of a Clinical Trial.

NIH Clinical Trials

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

The National Institutes of Health (NIH) is launching a series of initiatives that are rolling 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:  

For additional information, see:

Notice to all academics from the Vice Chancellor Research "Recent Changes by NIH regarding Clinical Trials Definitions and Regulations"

UC PI Authored vs Industry Authored Protocols

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-authoredclinical 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.)

Reporting Requirements to ClinicalTrials.gov

ClinicalTrials.gov –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.

IDC Rate for Clinical Trials

  • PI-authoredor Industry authored clinical trials, where a private sponsor is 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:

Sponsored Projects Offices – Which Office do I work with?

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

Office Type of Clinical Trial Funding Source Protocol Authorship

Office of Clinical Trials Administration

(OCTA)
Industry-authored, 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-authored Clinical Trial Either direct funding or flow-through

UC San Diego PI either:

  • Solely, or Jointly with a Non-UC San Diego PI*

*e.g. employee of another entity, other non-profit institution, sponsor, etc.

Sponsor-authored, Non-Profit Funded Clinical Trial Non-profit entity (often a hospital)

Non-UC San Diego PI 

Compliance Offices supporting Clinical Research/Trials

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

Government Agency Resources

UC BRAID Toolkit

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 

Kuali Research Proposal 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-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.  

For more information, contact our main desk at 858-534-3330 or email ocgainfo@ucsd.edu.