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PI-Initiated vs. Industry-Initiated Clinical Trials

Read about the differences between principal investigator initiated (PI-initiated) and industry-initiated clinical trials.

Categories  PI-Initiated Industry-Initiated
Responsible Office Office of Contract and Grant Administration (OCGA) Office of Clinical Trials Administration (OCTA)
Protocol  a) Protocol authored by a UCSD Investigator within the course and scope of his/her University employment; or
b) A UCSD 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 and employee of the company funding the study)
a) Protocol is authored by a non-UC employee  (i.e. the company's employee or an employee of an outside university or institution), or
b) A University investigator under a personal consulting agreement and without use of University facilities in accordance with UC Policies
Indirect Cost 
  • 30% IDC assessed on total direct costs (TDC) effective July 1, 20161
  • 26% IDC will remain in effect for all existing agreements issued prior to June 30, 2016 for the remaining term2
  • Non-profit organization-funded clinical trials are subject to the sponsor policy for IDC (see Nonprofit Indirect Costs)
  • Federally funded clinical trials are subject to the applicable federal negotiated rate, on campus 55% MTDC or off campus 26% MTDC  

Industry-Initiated:  30% Clinical Trial IDC (assessed on all costs), effective July 1, 2016. Refer to message dated January 22, 2016 from Dr. David Brenner, Vice Chancellor, UC San Diego Health Sciences and Dean of the School of Medicine, and Pierre Ouillet, Vice Chancellor and Chief Financial Officer for UC San Diego and Acting Chief Financial Officer for Health Sciences, to UC San Diego Health Sciences Employees.

Funding Source An Investigator-Initiated Clinical Trials may be funded by a for-profit, non-profit, state, or federal agency. A for-profit entity must be the source of funding for an Industry-Initiated Clinical Trial.
Payment  Although the actual payment schedule is subject to negotiation with the company, 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, as appropriate. 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. Although the actual payment schedule is subject to negotiation with the 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 as appropriate. Subsequent payments may be due quarterly, or based on subject enrollment. The University should not underwrite expenses for the sponsor, and reimbursement should remain current with expenditures throughout the life of the study.
FDA Phase  In general, Investigator-Initiated Clinical Trials are either Phase I or Phase II Trials and may be multi-site studies. In general, Industry-Initiated Clinical Trials may include Phase I through IV and are usually multi-site studies.
Investigational New Drug (IND)  Submitted to FDA by faculty Sponsor-Investigator Submitted to FDA by Sponsor
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 for publication.
a) The University retains the right to publish the results of the Clinical Trial consistent with University policy.
b) The Principal Investigator coordinates with the industry sponsor to determine who will assume responsibility for registering the trial so the results may be published.
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 will be granted certain non-commercial rights to the invention.

In general, the industry sponsor will own any patentable inventions developed in the direct performance of the protocol.
Data  a) The company 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 company for any purpose, subject to the University's intellectual property and publication rights.
b) Since the company funding the trial is not the regulatory "sponsor" as the term is defined in the Code of Federal Regulations 21CFR50, the company may not access medical records or other patient identifying information unless a revised authorization specific to the study, and which complies with the Confidentiality of Medical Information Act (CMIA) requirements is obtained from the subject.
a) The industry sponsor owns the completed case report forms and compilation of data expressed therein that is developed under the trial, and any deliverables required under the protocol. However, the University retains the right to use the case report forms and results for publication, educational and research purposes.
b) The industry sponsor may receive and use de-identified clinical trial specimens (blood samples, x-rays, etc.).
c) The University retains ownership and unrestricted use of original "raw" data including clinical trial specimens. The industry sponsor may have access to raw data for FDA inspection/monitoring.
d) The industry sponsor may access, but not copy, subjects' medical records containing individual identifiable patient information for the limited purpose of auditing data quality and monitoring the study as required under FDA regulations. The disclosure is allowed under HIPAA, however, such disclosure is not allowed under the Confidentiality of Medical Information Act (CMIA) without subject's authorization.
Subject Injury Except for injury attributable to the manufacture of the study drug, 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.
Required Forms a) ePD record
b) 700-U Conflict of Interest Form completed for the PI and Co-PI  
c) Statement of Work (i.e. protocol)
d) Budget (the budget includes any sub sites participating in the study)
a) ePD record
b) 700-U Conflict of Interest Form completed for the PI and Co-PI
c) Budget (the budget includes any sub sites participating in the study)
d) HIPAA Authorization
Authorized Administrative Office Investigator-Initiated Clinical Trials are processed and negotiated by the Office of Contract & Grant Administration (OCGA).  Industry-Initiated Clinical trials are processed and negotiated by the Office of Clinical Trials Administration (OCTA).
Accounting Index set up through OPAFS Index set up through OCTA

1 Effective July 1, 2016, the indirect cost (IDC) rate for any new Industry funded PI-initiated clinical trial agreement will be assessed at 30% IDC rate.  The new rate applies to all new proposals and renewals (where discussions and negotiations commence July 1, 2016 or later), for a proposed new Industry funded, PI-initiated clinical trial.

2 The 26% rate will be permitted to continue for the remaining term of existing agreements issued prior to June 30 2016, so that investigators with clinical trials underway are not disadvantaged. All new proposals and renewals will be budgeted at the higher rate.