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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) -
    • 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 TypeAgreement DescriptionIntake/Proposal Handled byAward 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 - RMGCTCO - 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 - RMGCTCO - RMG
Transfer of Materials or Data
Material Transfer AgreementTransfer 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 AgreementTransfer 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 AgreementTransfer of data into and out of StanfordNo Proposal

Industry = CO - ICO

All Others = OSR

Materials and Data Use Agreement (combination)Transfer of both data and materialsNo proposalICO

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
SubawardsOutgoing 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 AgreementsMembership in Affiliate Programs CO - ICO
Service AgreementsStanford is performing a service for an outside entityn/aSchools
University Research AgreementsAgreements funded by internal Stanford programs to support research.  The funding is provided through an internal competitive application and award process entirely within Stanford.  OSROSR