UCSD Health Sciences BUSINESS CONTRACTING

1. UCSD Health SciencesBUSINESS CONTRACTING Robin Samit, Esq. Director of Business Contracting rsamit@ucsd.edu

2. UNIVERSITY MISSION • Transactions are required to advance the UC mission of education, research, community service. • Agreements must balance UCOP policy, all legal requirements, and business decisions.

3. TYPES OF AGREEMENTS • Clinical Service Agreement (CSA) • Service (SER) • Laboratory Services (LSA) • Affiliation (AFF) • Provider (PVR)

4. TYPES OF AGREEMENTS • Service Agreements: • Clinical Service Agreement (CSA) or Service (SER) • UC provides a service for a fee. • Professional (Medical director, Patient care, Clinical trial oversight, Faculty consulting, Data management for multi site studies) • Clinical (nurses, dieticians, research personnel) • Educational programs: CME, Preceptorships, Community health outreach)

5. TYPES OF AGREEMENTS • Laboratory Services (LSA) – pre-clinical activity involving non-human clinical observation such as performing assays, gathering data, testing propriety substances in a controlled setting. The results are the Deliverables provided to the sponsor and often consisting of routine statistical data.

6. TYPES OF AGREEMENTS • Affiliation (AFF) – An inter-institutional agreement which provides for the training of undergraduate medical and pharmacy students and/or graduate medical and pharmacy students (residents and fellows) at hospitals and clinics and which meets the requirements of UCOP and accrediting organizations (ACGME, LCME, ASHP,ACPE).

7. For Affiliation Agreements, contact: Vicki Palladino Business Contracting Analyst vpalladino@ucsd.edu (858) 534-2041 TYPESOF AGREEMENTS

8. TYPES OF AGREEMENTS • Provider (PVR) – Agreements covering SOM purchase of services from outside providers that involve patient services (billing services, professional services, facility use). These transactions are rare and are distinguished from basic purchase orders issued by the purchasing department because they involve highly regulated medical group functions.

9. THE AGREEMENT PROCESS 1. Data form and scope of work, establish database record.

10. THE AGREEMENT PROCESS 2. If service agreement is with a for profit company, PI requires conflicts of interest clearance – Form 700U

11. THE AGREEMENT PROCESS • If LSA – requires submission of OCGA questionnaire to determine if project is service or research. • Negotiations (external and internal (as required referral to or review from OCGA, COI, IRB, TTIPS)

12. THE AGREEMENT PROCESS • Written Approvals – PI, Department Chair or Business Officer, Associate Vice Chancellor, UCOP General Counsel, etc. • Execution • Index Number assigned, copies routed to UCOP, campus, departments • Renewal or Termination

13. Database Agreement Status • ACTIVE – A fully executed agreement with all provisions in full force and effect and binding on all parties. • PENDING – A new agreement that is being processed and negotiated. • AMENDING- An existing agreement that is being amended to extend the term and/or modify conditions. • SIGNATURE– A new agreement or amendment to an existing agreement that has been finalized and sent out for signature to the other party. • WITHDRAWN – A agreement that was never active because the project was dropped by UCSD or the other party. • REFERRED – A potential agreement reviewed by Business Contracting and referred to another department (i.e. OCGA or Clinical Trials) • CLOSED – An agreement that is expired or is permanently terminated.

14. QUESTIONS?

15. For Further Information Please Contact: Robin Samit, Esq. Director of Business Contracting rsamit@ucsd.edu (858) 822-3474