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

2. 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.

3. 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
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4. 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 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.

5. Confidential Disclosure Agreements (CDAs)
What to do:
Contact ORC prior to disclosure of information
Forward the original 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.

6. 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.

7. Transfer of Data and Samples
What to do:
Forward the original 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.

8. 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.

9. 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.

10. 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.

11. 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 -
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12. eIRB HRPP Reviews Required:
Copyright 2018 Duke University. All Rights Reserved

13. How to Contact ORC Thank You! Duke Site Base Research:
(*) Oshrat BenMoshe-Doriocourt, LL.M (*) Marti Salguero, B.A.
(919) (919)
Research Program Collaborations:
Susan Hayden, J.D.
(919)
Non-Clinical Research Group:
Curtis Bradney, Ph.D.
(919)
Government and Foundations
Jennifer McCallister, J.D.
(919)
Please visit our website at -
Thank You!
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