Clinical Trials
Investigator-Initiated Clinical Trials
For Frequently Asked Questions, click here.
For an Investigator-Initiated vs. Industry-Initiated Clinical Trials Quick Reference Guide, click here.
A. Protocol for Investigator-Initiated Clinical Trials:
The protocol is authored by:
A UCSD Investigator within the course and scope of his/her University employment, or
A UCSD Investigator within the course and scope of his/her University employment jointly with an employee of another entity (i.e. an employee of another non-profit institution, an employee of the industry-sponsor, etc.).
B. Indirect Cost Rate for Investigator-Initiated Clinical Trials:
Investigator-Initiated Clinical Trials are subject to the 26% (Total Direct Cost) Clinical Trial Indirect Cost Rate.
If the clinical trial is funded by a non-profit organization, contact Carroll Ekberg at the Office of Contract and Grant Administration at 858-534-9884 for information on the applicable indirect cost rate.
C. Funding Source for Investigator-Initiated Clinical Trials:
Investigator-Initiated Clinical Trials may be funded by a for-profit entity, non-profit foundation, or a charitable organization.
D. Payment Schedule for Investigator-Initiated Clinical Trials:
Although the actual payment schedule is subject to negotiation with the funding entity, the Principal Investigator and departmental administrators should develop a suggested payment schedule that is based upon the spending pattern anticipated for the study.
The University may not underwrite expenses for the funding entity, and reimbursement should remain current with expenditures throughout the life of the study.
The initial payment should include non-refundable start-up costs, as appropriate.
Subsequent payments may be due quarterly, or based on subject enrollment.
Since payment options may vary, contact Carroll Ekberg at the Office of Contract and Grant Administration at 858-534-9884 to discuss appropriate payment terms for a specific Clinical Trial.
E. FDA Phase for Investigator-Initiated Clinical Trials:
- In general, Investigator-Initiated Clinical Trials are either Phase I or Phase II trial and may be multi-site studies.
F. Investigational New Drug (IND) for Investigator-Initiated Clinical Trials:
The FDA form 1571 is completed by the Principal Investigator who takes responsibility for and initiates the clinical investigation.
For additional information, forms, regulations, and guidance, click here or
To access forms directly, click here.
G. Publication and Mandatory Registration Requirements for Investigator-Initiated Clinical Trial Results:
The University retains the right to publish the results of the Clinical Trial consistent with University policy.
Public Law 110-85, the FDA Amendments Act, mandates registration of Phase 2 - 4 clinical trials of drugs and biologics, and devices. 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, click here.
For further detailed information, click here.
H. Intellectual Property Rights for Investigator-Initiated Clinical Trials:
The University retains all rights to such inventions developed under the study.
If the funding source for the Clinical Trial is a for-profit entity, the entity will be granted the first right to negotiate for a license to commercialize the invention.
If the funding source is a non-profit entity, the non-profit entity will be granted certain non-commercial rights to the invention.
I. Data for Investigator-Initiated Clinical Trials:
The entity funding the Clinical Trial receives a summary report of the results of the trial, and may receive case report forms as appropriate.
The report may be used by the funding entity for any purpose, subject to the University's intellectual property and publication rights.
Since the entity funding the trial is not the regulatory "sponsor" as the term is defined in the Code of Federal Regulations 21CFR50, the company representatives may not access medical records or other patient identifying information unless a revised authorization specific to the study and which complies with the California Medical Information Act (CMIA) requirements is obtained from the subject. The UC HIPAA Authorization is used to ensure compliance with both state and federal laws.
J. Subject Injury for Investigator-Initiated Clinical Trials:
Except for injury attributable to the manufacture of the study drug, the University assumes responsibility for any injury directly resulting from the subjects's participation in the Investigator-Initiated trial.
The University will provide medical treatment for any such injuries.
It is unacceptable to require billing of third party insurance companies in lieu of recovery of such costs.
Neither is it appropriate to restrict participation of subjects based on medical insurance coverage status or the subject's ability to pay.
K. Required Forms for Investigator-Initiated Clinical Trials:
- The completed forms, 1-4 below, are to be submitted
to the Office of Contract and Grant Administration; Mail Code 0934.
- Request for Extramural Support (RES Form)
- 700-U Conflict of Interest Form completed for the PI and Co-PI
- Budget including 26% IDC. Budget includes any subsites participating in the study
- Statement of Work (i.e. protocol) There is no standard form for the statement of work.
The completed UC HIPAA Authorization form is to be submitted to the Human Research Protections Program Office; Mail Code 0052. A copy is also sent to the Office of Contract and Grant Administration; Mail Code 0934.
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The completed Institutional Research Bulk Account Application form is to be submitted to the Clinical Trial Administrative Services and Research Compliance Office (CTAS) Office; Mail Code 0706. A copy is also sent to the Office of Contract and Grant Administration; Mail Code 0934.
L. Authorized Administrative Office for Investigator-Initiated Clinical Trials:
Investigator-Initiated Clinical Trials are processed and negotiated by the Office of Contract and Grant Administration (OCGA); Mail Code 0934. Please contact Carroll Ekberg at caekberg@ucsd.edu or at 858-534-9884 with any questions.
