Agreement Assignment Matrix

Stanford enters into many types of agreements for various purposes. Several Institutional Offices handle such agreements. Depending on the type of agreement, one or more of the following offices may be involved in the intake, proposal review, and negotiations process:

Office of Sponsored Research (OSR)
School of Medicine Research Management Group (RMG) -
- Research Process Manager (RPM)
School of Medicine Clinical Trials - Research Management Group (CT-RMG)
- Clinical Trials Research Process Manager (CT-RPM)
- Clinical Trials Contract Officer (CTCO)
Industrial Contracts Office (ICO)
- Contract Officer (CO)
Procurement
Office of General Counsel (OGC)

Agreement Type	Agreement Description	Intake/Proposal Handled by	Award Handled by
*Clinical Trial with Human Subjects or Related Agreement*
Industry-Sponsored Clinical Trial	Sponsor or PI-initiated study to test the safety and efficacy of a drug, device, diagnostic tool, or intervention using human subjects (i.e., any project meeting RPH 13.3.1 definition of industry-sponsored clinical trial). Device, drug, treatment not yet FDA-approved or data collected for regulatory submission to FDA Human subject research deemed high risk by IRB	CT-RPM - RMG (SeRA Proposal Development Routing Form PDRF)	CTCO - RMG
Agreements related to an Industry-Sponsored Clinical Trial at Stanford University	All agreements related to any agreement that meets the RPH 13.3.1 definition of industry-sponsored clinical trial. This may include (but is not limited to): Material or device Medical record reviews Equipment loan Data use NDA Subaward	CT-RPM - RMG	CTCO - RMG
Compassionate Use/Expanded Use/Emergency Use INDs/IDEs	Permission from FDA for use of a non-approved drug or device for an individual patient treatment, outside an FDA-approved protocol.	CT-RPM - RMG	CTCO - RMG
*Transfer of Materials or Data*
Material Transfer Agreement	Transfer of materials from one lab to another. [Not for use in humans, may include human tissue if in-coming.]	No PDRF ICO Intake Form - PI	CO - ICO* *If materials are related to an Invention, ICO may transfer outgoing MTAs to the Office of Technology Licensing (OTL) Agreements Group.
Clinical Materials Agreement	Transfer of drug or device from a company to Stanford for use or testing in a proposed clinical trial or human subjects.	No Proposal ICO Intake Form - PI	Industry Prime = CTCO - RMG All Other = CO - ICO
Human Tissue Agreement	Transfer of human tissues out of Stanford. *Incoming human tissue agreements are considered Material Transfer Agreements. See Above.	No proposal ICO Intake Form - PI	CO - ICO
Data Use Agreement	Transfer of data into and out of Stanford	No Proposal	Industry = CO - ICO All Others = OSR
Materials and Data Use Agreement (combination)	Transfer of both data and materials	No proposal	ICO
Complex Agreements	Multiple Parties, Agreements, Relationships as identified at time of Award	May need SeRA PDRF if Grant, SRA	Multi-Unit (RMG, ICO, OSR, Procurement, OGC)
*Research-Related Agreements*
Contracts, Industry (direct)	Includes all non-clinical trial-related agreements directly funded from industry: Industry sponsored research agreements $0 collaboration NDA Equipment Loan Service agreement Research licenses Animal research, pre-clinical Lab-based research Human subjects research deemed low risk by IRB, e.g., chart reviews, registries, observational studies. Clinical research, especially under master agreements with GE, Varian, Siemens, Phillips as long as they are not CTs.	SoM = RMG Other Schools = OSR	CO - ICO
Contracts, Non-Industry	Contractual agreement with a non-industry sponsor for sponsored projects or research related purposes Sponsored research agreements Equipment loan $0 collaboration Non-sponsored funded collaboration IPA JPA CRADA Master Agreement Facility Use Agreement	SoM = RMG Other Schools = OSR SoM IPA/JPA = OSR SoM CRADA = OSR	OSR
Subcontracts	Stanford is a subcontractor under another institution’s sponsored award regardless of prime source Prime = Industry sponsored clinical trial, handled by CT RMG	SoM = RMG Other Schools = OSR	OSR CTCO - RMG
*Grants*
Grants (All Federal)	Grant agreement with standard terms and conditions that comply with Stanford policy	SoM = RMG Other Schools = OSR	RMG Other Schools = OSR
Grants (All Non-Federal)	Grant agreement with Special Conditions (see attachment)	SoM = RMG Other Schools = OSR	OSR
*Other Agreements*
Subawards	Outgoing subcontract from Stanford to another institution where that institution performs a portion of the scope of work.		If prime is industry CT = CT-RMG All other = OSR
Affiliate Agreements	Membership in Affiliate Programs		CO - ICO
Service Agreements	Stanford is performing a service for an outside entity	n/a	Schools

Agreement Assignment Matrix

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