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Reminder

Compliance protocols MUST be approved and linked in SeRA to a SPO project record prior to award acceptance. 

See ORA's Award Acceptance Resources for additional information.

Agreement Assignment Matrix

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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)
  • Industrial Contracts Office (ICO)
  • 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 (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

CTRPM - 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.

CTRPM - 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 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 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