Industry Funded Research - Process for Contracts Duke University Office of Research Contracts (ORC) Copyright 2018 Duke University. All Rights Reserved.

Within ORC 25 Research Agreement Managers: 17 Research Agreement Managers – industry supported research 8 Research Agreement Managers – federal and foundation supported research; Research Agreement Manager you have been working with; Research Agreements are assigned by experience with prior agreements of a type; Generally same Research Agreement Manager handling agreements from a given company. Copyright 2018 Duke University. All Rights Reserved.

Industry Funded Research - Process for Contracts Types of agreements that ORC handles and signs: - Confidentiality/Non Disclosure Agreement (CDA or NDA) - Core Lab Research Agreements - Clinical Research/Trial Agreements (CRA or CTA) - Clinical Trial Agreements for DCRI as a coordinating center - Data Use Agreements for HIPAA Limited Data Sets (DUA) - Data Transfer Agreements (DTA) - Federal Grants and Contracts - Foundation Grants - Material Transfer Agreements (MTA) - Non Clinical Research Agreements for a common non-clinical research interest - Non-CME and CME Educational Program Agreements - Outside Services Agreements - Amendments - Other Copyright 2018 Duke University. All Rights Reserved.

For Finalizing a Contract - Study Initiation Process ORC * Negotiates the legal terms and conditions; * Reviews research related injury language in ICF and posts Mods on the eIRB; * Confirms compliance with the SoM policy on budgets and payment terms; IRB Reviews the protocol. DOCR – billing review * DOCR will email study teams to schedule a meeting to discuss their protocol and related study documents. DOCR will gather the information necessary to create the study calendar and order set that will be built in Maestro Care. ORC – signature process for industry funded clinical research * Reviews conflict of interest statement * Reviews budget * Reviews SPS * Notifies IRB when a fully executed contract has been received * Signs the contract CRU * Negotiates budget and payment terms * Initiates protocol process * Provides internal cost assessments. Copyright 2018 Duke University. All Rights Reserved.

Confidential Disclosure Agreements (CDAs) What to do: Contact ORC prior to disclosure of information Forward the original email and attachment to ORC for review Identify the Duke investigator IMPORTANT: DO NOT SIGN If your investigator/CRU decides it is no longer interested in the protocol, please notify ORC to stop negotiation and close its file. Copyright 2018 Duke University. All Rights Reserved.

Confidentiality 1) Duke does not conduct secret research in humans; 2) As an academic institution ORC ensures: 1) Duke’s right to publish and 2) its faculty’s academic freedom to share their knowledge with their peers; 3) Duke’s academic mission statement; 4) Long-term confidentiality obligations are unrealistic in an academic environment. Copyright 2018 Duke University. All Rights Reserved.

Transfer of Data and Samples What to do: Forward the original email and attachment to ORC for review; Contact ORC to draft the appropriate agreement; Identify the Duke investigator When an Investigator leaves Duke and wants to take data and/or samples with him/her – please contact: IRB; ORC - Research Program Collaborations (Data); Non-Clinical Research Group (Samples); and DOCR Data Use Agreement (DUA) Material Transfer Agreement (MTA) Data Transfer Agreement Copyright 2018 Duke University. All Rights Reserved.

Clinical Research Agreements Terms and conditions governing the parties conduct of the clinical trial; The parties are always Duke University and the Sponsor/CRO (investigator may sign as “Read and Acknowledged”); Includes budget and payment terms as well as legal/regulatory terms. IMPORTANT: If your investigator/CRU decides to drop participation, please notify ORC to stop negotiation and close its file. Copyright 2018 Duke University. All Rights Reserved.

Clinical Research Agreements ORC Reviews, negotiates and approves the terms and conditions to assure that terms are reasonable, and compliant with Duke’s policies and Duke’s tax-exempt status; Requests Budget and Payment terms from CRUs – compliance with the SoM Policy; Confirms research related injury language in the ICF is consistent with the contract; Outside IRB – RRIL in the outside IRB-approved ICF SPS record in PNCA status; Contracts are routed to ORC’s executive director for signature. Copyright 2018 Duke University. All Rights Reserved.

Intellectual Property Duke University is a tax-exempt, non profit, 501(c)(3) institution. Use of research facilities built with tax-exempt bonds require special attention to intellectual property (essentially all of our research and clinical facilities). Duke does not provide contract services (and cannot under IRS regulations); e.g., no “work for hire”. Duke cannot grant title to inventions made by its personnel through use of its tax-exempt facilities. Duke does not assert any rights in inventions made by a Sponsor. We will grant title to inventions that represent a reduction to practice of Sponsor’s conception since conception is the basis of inventorship, and will negotiate rights to inventions that relate directly to a Sponsor’s drug. The Sponsor is granted an option to negotiate a license on reasonable terms to inventions made by Duke and arising from research funded by the Sponsor. Copyright 2018 Duke University. All Rights Reserved.

Reimbursement for Subject Injury Sponsor arguably has a moral obligation to the Study subject to reimburse if Sponsor’s protocol and/or Study Product caused an injury. Some Sponsors will ask that insurance be billed first, and to place various other limitations on their obligation. Medicare, Medicaid and Tricare cannot be billed. ORC will check the research related injury language in the ICF to ensure the Study subject is accurately informed of the sponsor’s contractual obligation. Research related injury language in the ICF should not be changed from what is approved without IRB approval and further review by ORC. IRB Resource - https://irb.duhs.duke.edu/standard-language/english-standard-language Copyright 2018 Duke University. All Rights Reserved.

eIRB HRPP Reviews Required: Copyright 2018 Duke University. All Rights Reserved

How to Contact ORC Thank You! Duke Site Base Research: (*) Oshrat BenMoshe-Doriocourt, LL.M. (*) Marti Salguero, B.A. oshrat.benmoshe@duke.edu marti.salguero@duke.edu (919) 681-9712 (919) 681-6483 Research Program Collaborations: Susan Hayden, J.D. susan.hayden@duke.edu (919) 684-0048 Non-Clinical Research Group: Curtis Bradney, Ph.D. curtis.bradney@mc.duke.edu (919) 668-3127 Government and Foundations Jennifer McCallister, J.D. jennifer.mccallister@duke.edu (919) 668-1759 Please visit our website at - https://medschool.duke.edu/research/research-support-offices/office-research-contracts Thank You! Copyright 2018 Duke University. All Rights Reserved.