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PI vs. Industry vs ‘Other Sponsor’ Authored Clinical Trials - Quick Reference Guide

Read about the differences between Principal Investigator authored (PI-authored), Industry-authored, and 'other sponsor' authored clinical trials.

Categories  UC PI-Authorized Industry-Authorized Other Sponsor Authored Clinical Trials
Responsible Office and Authored Administrative Office Office of Contract and Grant Administration (OCGA) Office of Clinical Trials Administration (OCTA) Office of Contract and Grant Administration (OCGA)
Protocol  a) Protocol authored by a UC Investigator within the course and scope of his/her University employment; or
b) Protocol is authored by a UC Investigator within the course and scope of his/her University employment jointly with an employee of another entity (e.g. an employee of another non-profit institution or an employee of the company funding the study)
a) Protocol is authored by an industry employee  (i.e. the company's employee), or
b) A UC investigator under a personal consulting agreement and without use of University facilities in accordance with UC Policies

Protocol: Protocol is not authored by a UC investigator nor an industry partner. For example, the Protocol may be authored by a PI at a non-profit entity or an organization that benefits from non-profit status.

Typically the party that designed, developed, and authored the Protocol is the regulatory sponsor of the Protocol with responsibility for the clinical investigation to the FDA.

Indirect Cost 
Funding Source Any Industry Any
Payment  Although the actual payment schedule is subject to negotiation with the financial sponsor, the Principal Investigator and departmental administrators should develop a suggested payment schedule that is based upon the spending pattern anticipated for the study. The initial payment should include non-refundable start-up costs. Subsequent payments may be due quarterly, or based on subject enrollment. The University may not underwrite expenses for a for-profit funding entity, and reimbursement should remain current with expenditures throughout the life of the study.
Investigational New Drug (IND)/ Investigational Device Exemption (IDE) Submitted to FDA by UC Principal –Investigator (regulatory sponsor) Submitted to FDA by Industry Sponsor  Submitted to FDA by regulatory sponsor (non-UC)
Publication a) The University retains the right to publish the results of the Clinical Trial consistent with University policy.
b) The Principal Investigator is responsible for registering the trial with the applicable entities to ensure publication.
a) The University retains the right to publish the results of the Clinical Trial consistent with University policy.
Intellectual Property The University retains all rights to inventions developed under the Study, including inventions utilizing the Study drug. 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 such invention. If funding source is a non-profit entity, the non-profit entity shall be granted certain non-commercial rights to the invention. In general, the industry sponsor will own any patentable inventions made in the direct performance of the protocol. If funding source is a non-profit entity, the non-profit entity shall be granted certain non-commercial rights to the invention.  A request for policy exceptions to UCOP may be required. 
Subject Injury Except for injury attributable to the manufacture of the study drug/device, the University assumes responsibility for any injury directly resulting from the subject's participation. 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. The industry sponsor is responsible for any injury directly resulting from a subject's participation in the trial, or injuries resulting from the study drug, or the placebo, or protocol procedures. The industry sponsor will reimburse the University for the costs of medical treatment for 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. The University or sponsor may assume responsibility for any injury directly resulting from the subject's participation. 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.
Accounting Oracle accounting string set up through OPAFS, after the award is executed, is received, confirmed and entered into Kuali Research. Oracle accounting string set up through OCTA after the award is executed, received, confirmed and entered into Kuali Research. Oracle accounting string set up through OPAFS, after the award is executed, is received, confirmed and entered into Kuali Research.

 

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