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PI-Initiated Clinical Trials

Find links to information on Principal Investigator-initiated clinical trials.

Looking for industry-initiated clinical trials? Go to the Office of Clinical Trials Administration (OCTA).

About Clinical Trials

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-initiated Clinical Trials.

In addition, 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.

PI-Initiated vs. Industry-Initiated Clinical Trials

Studies may be conducted under an industry-developed protocol or a principal investigator-developed protocol

For details, go to the PI-Initiated vs. Industry-Initiated Clinical Trials Quick-Reference Guide page.

National Institutes of Health (NIH)

The National Institutes of Health (NIH) has recently clarified its clinical trials definition.

Go to the NIH Clinical Trials Definition and Regulations page for more information.

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PI-initiated Clinical Trial Protocol

A clinical trial is considered PI-initiated when the protocol is authored by:
  • UC San Diego investigators within the course and scope of their University employment, or
  • UC San Diego 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.)

IDC Rate for PI-initiated Clinical Trials

  • Private Industry PI-Initiated clinical trials 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. The previous 26% TDC rate will be permitted to continue for the remaining term of existing agreements.
  • Non-profit organization-funded clinical trials are subject to the sponsor policy for IDC. (See Nonprofit Indirect Costs)
  • Federally-funded clinical trials, including subawards, are subject to the applicable federal negotiated rate, on campus 55% MTDC or off campus 26% MTDC.
Read the official announcements regarding IDC rate for clinical trials:

Clinical Trials Registration

UC Office of the President Letter on Registration of Clinical Trials (PDF)

Public Law 110-85, the FDA Amendments Act, mandates registration of Phase 2–4 clinical trials of drugs and biologics, and devices on ClinicalTrials.gov. The principal investigator is responsible for registering such Investigator-Initiated clinical trials. Although registration of Phase 1 clinical trials is not required under the Act, the ICMJE may require that the trial is registered in order for the results to be considered for publication in an ICMJE journal. The Principal Investigator is responsible for registering the trial for publication. 

To register your Investigator-Initiated clinical trial go to ClinicalTrials.gov.

FDA-3674 Clinical Trials Registration Compliance Form (PDF)

Required UC San Diego forms

Submit the following to the Office of Contract and Grant Administration:
  1. ePD record 
  2. 700-U Conflict of Interest Form completed for the PI and Co-PI
  3. Statement of Work (i.e., protocol). There is no standard form for the statement of work.
  4. Budget in major cost categories (standard UCSD budget or UCSD Clinical Trials fully loaded budget). The funding entity may require a per-patient costs budget as well.

Resources

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 Initiated Trial Contracting Delays 

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