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Industry and Non-Industry

The Industry and Non-Industry Contracting team is responsible for reviewing and executing agreements with industry for sponsored projects, including sponsored research and clinical trial agreements. The team is also responsible for all (industry, federal, non-profit) data use/transfer and research confidentiality agreements as well as other unfunded agreements to support UNC’s research community opens in a new tab.

Please reference the information on this page to help you determine the type of agreement you need to process and method for their submittals to the Industry Contracting team for review. Please also contact OSPContracting@unc.edu for any additional assistance.

Industry Agreements

Agreement Types and SubtypesRouting SystemInstructions
Clinical Trial Agreement (CTA), including:

  • Incoming Clinical Subcontract

  • Task/Work Order under Master Clinical Agreement

  • Investigator Initiated Trial (IIT)

  • CTA Amendment

  • ACTA

CRMSCRMS opens in a new tab
CTA Amendments:

  • If you have an existing CTA record in CRMS, please access that CRMS number, click Submission tab, click OIC, and select Non-CTA Agreement Request Form to submit there.

  • If you do not have an existing CRMS record, you can submit the amendment in ALICE opens in a new tab.
Clinical Subsite AgreementCRMS/ALICESubcontract Request Process (PDF)

  • If you have an existing prime CTA record in CRMS, please access that CRMS number, click Submission tab, click OIC, and select either Submit CDA Request Form or Submit Amendment Request Form. This will redirect to ALICE to continue the submission.

  • If you do not have an existing CRMS record, you can submit the request in ALICE opens in a new tab and select Non-CTA Agreement Request.
Confidentiality/Nondisclosure Agreement (CDA), including Task Orders under a Master CDA for the following:

  • CDA for Clinical Purposes

CRMSCRMS opens in a new tab

  • CDA for Non-clinical Purposes

ALICEALICE opens in a new tab

  • CDA for Licensing, Patenting, and other Intellectual Property Transactions

These are handled by the Office of Technology Commercialization. Please submit a new CDA request via email to otc_cda@unc.edu

Click here for CDA instructions opens in a new tab
Core Recharge Service Center AgreementResearch Service Center/Core Agreement Form
Data Use/Share/Transfer (DUA), including Amendments for the following:

  • DUA with CMS (Centers for Medicare & Medicaid Services)

Please submit requests and questions to OSPContracting@unc.edu.

  • DUA with NIH dbGaP

These are handled through the NCBI dbGaP online portal opens in a new tab.

The SO listed should be from Industry Contracting. For questions email OSPContracting@unc.edu.

  • DUA for CDW/TraCS (Carolina Data Warehouse)

These are handled by NC TraCS. Please submit a CDW-H Project Data Request opens in a new tab.

  • Any other type of DUA

ALICEALICE opens in a new tab
Material Transfer Agreement (MTA)

  • MTA with funding (shipping and handling is not considered funding)

RAMSeSRAMSeS opens in a new tab

  • MTA without funding (shipping and handling is not considered funding) and/or

  • MTA for deidentified clinical samples collected from clinical trials and being shared for purposes ancillary to the original trial

BLUEThese are handled by the Office of Technology Commercialization. Please submit a new MTA request here opens in a new tab

Click here for MTA instructions opens in a new tab

  • MTA for materials to be used in humans in a clinical trial or for which PHI is being exchanged

ALICEALICE opens in a new tab
Master Agreement, including:

  • Master CDA

  • Master CTA

  • Master Research Agreement

  • Master Service Agreement

  • Amendment without funding (e.g. no-cost extension)

ALICEALICE opens in a new tab
Sponsored Research Agreement (SRA), including:

  • Service Agreement

  • Amendment adding funding

  • Task/Work Order under Master Nonclinical Agreement


RAMSeSRAMSeS opens in a new tab
Collaboration Agreement, including:

  • Other agreement type without funding

ALICEALICE opens in a new tab
Amendment without funding, including:

  • Collaboration Agreement Amendment

  • DUA Amendment

  • SRA Amendment

  • Service Agreement Amendment

  • Master Agreement Amendment

  • Task/Work Order Amendment (Nonclinical)

ALICEALICE opens in a new tab

ALICE Submittals

Unfunded agreements, such as Data Use Agreements (DUAs), Confidential Disclosure Agreements/Non-Disclosure Agreements (CDAs/NDAs), collaboration agreements, master agreements, and amendments with no change in funding. Please see ALICE Submission Guidance (PDF) for more information.

Core/Recharge Service Center Agreements

Complete the online form, uploading all associated material necessary with your submission. If you need to provide any additional documentation or have questions, please contact OSPContracting@unc.edu.

Clinical Research Management System (CRMS)

A confidentiality agreement for information shared in advance of a specific clinical trial, clinical trial agreement, or amendment to a clinical trial agreement. CRMS opens in a new tab will collect the information, and at the submission of the agreement in CRMS, the submitter will be redirected to ALICE opens in a new tab for completion of the submission process.

RAMSeS Submittals

All other funded agreements require an IPF and once it is approved by your department’s Sponsored Programs Specialist (SPS) opens in a new tab, it will be sent to OSP’s IC team to negotiate.

  • IPFs should include budget, the scope of work, draft agreement (if you have one), external contact for negotiations, and any other relevant information.

To learn more about the different research administration systems used at UNC, please see OSP’s Research Systems.

FormOfficeDescriptionOperating Standard and Procedure
Data Use Agreement Request Form (PDF)
UPDATED: 11/07/2023		OSPThis form should be completed and uploaded to ALICE when a new data use agreement is being requested.
Material Transfer Agreement Request Form (PDF)
UPDATED: 11/07/2023		OSPThis form should be completed and uploaded to ALICE when a new material use agreement is being requested.
Ledger 4 Date Change RequestOSPOnline request form to extend the end date or to closeout a Ledger 4 clinical trials.
Research Service Center/Core Agreement FormOSPGuidance on the different types of actions for Research Core Agreements and their corresponding online forms.
Resources
Guidance

Clinical Trials Agreements

Industry clinical trials are research studies in which one or more human subjects are prospectively assigned to one or more interventions (placebo and/or control) to evaluate the effects of those interventions on health-related biomedical and behavioral outcomes and are funded by private, for-profit entities.

All industry clinical trials should be submitted in ALICE opens in a new tab via CRMS opens in a new tab.

CRMS Submittals

A confidentiality agreement for information shared in advance of a specific clinical trial, clinical trial agreement, or amendment to a clinical trial agreement. CRMS will collect the information, and at the submission of the agreement in CRMS, the submitter will be redirected to ALICE for completion of the submission process.

Non-Clinical Funded Agreements

Any industry project or agreement receiving new funding must first be submitted as an IPF, in RAMSeS opens in a new tab, with the exception of agreements for UNC Research Service Centers (Recharge Centers) with approved rates.

The IPF must have a project description, a budget with appropriate F&A, and a draft agreement, if the sponsor has provided one. Any subsequent budget changes must be reviewed and approved by OSP before the agreement is signed, otherwise OSP is unable to set up a Project ID.

Once the IPF is reviewed and approved by OSP via RAMSeS opens in a new tab, IC will be notified and the agreement will be entered into ALICE opens in a new tab and assigned to one of the Contract Managers. Given the range of project and agreement types, your department’s Contract Manager will likely contact you to discuss your project or various provisions of the agreement to make sure your interests, in addition to UNC’s, are best served.

IC prefers to start from UNC’s template agreement, which can help decrease negotiation time, but some companies (particularly larger, international companies) will insist on starting from their template. If you would like to send UNC’s template agreement to the sponsor when discussing your project, please email OSPContracting@unc.edu and we can provide the current applicable version.

Master Agreements

Industry Master Agreements can be negotiated prior to having a set project and budget. If you are requesting a new Master Agreement without a project or budget determined, you can request review in ALICE opens in a new tab.

Clinical Master Agreements

Clinical Master Agreements should be submitted through ALICE opens in a new tab following the procedure above. Task/Work Orders should be submitted through CRMS opens in a new tab like any other industry clinical trial agreement. You can submit a CRMS record that includes both the Master and the Task Order in the same record.

Non-Clinical Master Agreements

If a project and budget has been determined with the sponsor, an IPF needs to be submitted in RAMSeS opens in a new tab for OSP review. Both the draft Master Agreement and the Task Order/Work Order for this first project should be uploaded to RAMSeS. In this instance, a separate request is not needed in ALICE for the Master Agreement alone.

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