Industry Contracting

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 for more information.

Core/Recharge Service Center Agreements

Go to the Research Core Agreements page, and complete the appropriate form. 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 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.

RAMSeS Submittals

All other funded agreements require an IPF and once it is approved by your department’s Sponsored Projects Specialist (SPS), 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.

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 via CRMS.

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, 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, IC will be notified and the agreement will be entered into ALICE and assigned to one of the Contracting Officers. Given the range of project and agreement types, your department’s Contracting Officer 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.

Clinical Master Agreements

Clinical Master Agreements should be submitted through ALICE following the procedure above. Task/Work Orders should be submitted through CRMS 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 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.