The Contracting ProcessThe Contracting Process(Why Does it Take So Long?)(Why Does it Take So Long?)

Libby Salberg, Associate DirectorLibby Salberg, Associate DirectorBeth Watkins, Contract Analyst, Team ManagerBeth Watkins, Contract Analyst, Team Manager

Janet Fry, Manager Clinical Research Janet Fry, Manager Clinical Research FacilitationFacilitation

Office of Grants and Contracts ManagementOffice of Grants and Contracts Management

The Contracting ProcessThe Contracting Process

Goal:Goal: To explain what we do from the time a To explain what we do from the time a research contract comes into our office research contract comes into our office through the point at which all parties have through the point at which all parties have signed off on a fully executed document.signed off on a fully executed document.Topics Covered:Topics Covered: (i) structure & organization (i) structure & organization of our office; (ii) mechanics of the contract of our office; (ii) mechanics of the contract process; and (iii) what we are looking for in process; and (iii) what we are looking for in our contract review.our contract review.

Contracts Staff StructureContracts Staff Structure

Contracts staff consists of 2 teamsContracts staff consists of 2 teamsEach team consists of a Team Leader, Contracts Each team consists of a Team Leader, Contracts Analyst Is and IIs, and an Administrative Assistant.Analyst Is and IIs, and an Administrative Assistant.Contracts Analyst Is typically handle federal and Contracts Analyst Is typically handle federal and nonfederal subcontracts, affiliation agreements, etc.nonfederal subcontracts, affiliation agreements, etc.Contracts Analyst IIs primarily handle Industry Contracts Analyst IIs primarily handle Industry Sponsored clinical trials and basic science Sponsored clinical trials and basic science agreements.agreements.

Mechanics of Our Research Contract Mechanics of Our Research Contract ProcessProcess

Step 1 – Receive and assign contractStep 1 – Receive and assign contractStep 2 – NegotiationStep 2 – NegotiationStep 3 – Finalization & ExecutionStep 3 – Finalization & ExecutionStep 4 – Follow-upStep 4 – Follow-up

Step 1Step 1Receive and Assign ContractReceive and Assign Contract

New contracts should be sent to New contracts should be sent to research.contracts@vanderbilt.eduresearch.contracts@vanderbilt.edu as part of a as part of a complete package - PI & Dept. Contact; Copy of complete package - PI & Dept. Contact; Copy of Protocol; External Contact Info, Contract as supplied Protocol; External Contact Info, Contract as supplied by sponsor, signed transmittal form and budget (draft by sponsor, signed transmittal form and budget (draft version is acceptable)version is acceptable)New Contracts will be assigned to a Contract Analyst New Contracts will be assigned to a Contract Analyst within 24 hours of receipt.within 24 hours of receipt.Dept.contact and PI will receive an email notifying Dept.contact and PI will receive an email notifying them of Contract Analyst assigned.them of Contract Analyst assigned.

Hospital Finance ApprovalHospital Finance Approval

While contract is under review and as soon While contract is under review and as soon as ready, submit;as ready, submit;Project Information SheetProject Information SheetClinical Research Budget GridClinical Research Budget GridClinical Trial Registration FormClinical Trial Registration FormInformed Consent DocumentInformed Consent Document

GCM will use these forms to obtain GCM will use these forms to obtain necessary approval from Department of necessary approval from Department of Finance.Finance.

Step 2Step 2Negotiation: General InformationNegotiation: General Information

Goal is to have a response to the External Party within 15 business days.Goal is to have a response to the External Party within 15 business days.Contract Analyst reviews agreement and determines whether terms need to Contract Analyst reviews agreement and determines whether terms need to be modified for pragmatic or policy reasons in accordance with Vanderbilt be modified for pragmatic or policy reasons in accordance with Vanderbilt Guidelines.Guidelines.Goal is Goal is notnot to have a perfect agreement but to have one in keeping with to have a perfect agreement but to have one in keeping with Vanderbilt’s guidelines. Vanderbilt’s guidelines. In course of review, CA may have questions for the department, PI, In course of review, CA may have questions for the department, PI, University Counsel, Technology Transfer or Risk Management.University Counsel, Technology Transfer or Risk Management.PI and Department will be copied on all correspondence from Contract PI and Department will be copied on all correspondence from Contract Analyst.Analyst.Budgets and payment terms are negotiated by the department, not OGCM. Budgets and payment terms are negotiated by the department, not OGCM. Janet Fry, Manager of Clinical Research Facilitation, is available to assist Janet Fry, Manager of Clinical Research Facilitation, is available to assist you with budget development and negotiation. Phone -65886 or email you with budget development and negotiation. Phone -65886 or email janet.fry@vanderbilt.edujanet.fry@vanderbilt.edu

Step 2Step 2Negotiation: Checklist, Sample ItemsNegotiation: Checklist, Sample Items

Document retentionDocument retentionNoticesNoticesAmendmentsAmendmentsConflict of termsConflict of termsHIPAAHIPAADocument RetentionDocument RetentionInsuranceInsuranceTerminationTermination

Confidential informationConfidential informationIntellectual propertyIntellectual propertyIndemnificationIndemnificationSubject injurySubject injuryBillingBillingPublicationsPublicationsUse of resultsUse of results

Step 2Step 2Negotiation: Negotiation: Why does it take so long?Why does it take so long?

Difference between what they offer & what Difference between what they offer & what Vanderbilt requires/needsVanderbilt requires/needsMain areas of contention: Main areas of contention:

• ConfidentialityConfidentiality• Intellectual PropertyIntellectual Property• IndemnityIndemnity• Subject InjurySubject Injury

Master AgreementsMaster Agreements

Step 2Step 2Negotiation: ImpasseNegotiation: Impasse

Team Leaders, as well as Associate Director and Director, Team Leaders, as well as Associate Director and Director, are available to consult.are available to consult.If Sponsor is insisting upon language outside of guidelines, If Sponsor is insisting upon language outside of guidelines, contract issue is brought to DCM (Difficult Contracts contract issue is brought to DCM (Difficult Contracts Meeting).Meeting).General factors weighed are nature of research, size of General factors weighed are nature of research, size of budget, and then particulars depending on issue (e.g. budget, and then particulars depending on issue (e.g. chance of IP arising from contract).chance of IP arising from contract).Dr. Gordon Bernard, Assistant Vice-Chancellor for Dr. Gordon Bernard, Assistant Vice-Chancellor for Research, is arbiter in such cases.Research, is arbiter in such cases.

Step 3Step 3Contract Finalized & ExecutedContract Finalized & Executed

Department is notified.Department is notified.Originals sent to OGCM for final proof-Originals sent to OGCM for final proof-reading & then routed to PI for signature.reading & then routed to PI for signature.OGCM will return originals to Sponsor & will OGCM will return originals to Sponsor & will keep original for VUMC and send a copy to keep original for VUMC and send a copy to Department.Department.

Step 4Step 4Follow-upFollow-up

Annual review to determine if contract needs Annual review to determine if contract needs to be terminated or extended.to be terminated or extended.

AmendmentsAmendments

Office of Grants & Contracts ManagementOffice of Grants & Contracts ManagementGoalsGoals

The goal of our office is to facilitate—not The goal of our office is to facilitate—not impede—the progress of research at VUMC.impede—the progress of research at VUMC.We are actively working to improve our We are actively working to improve our internal processes, databases and our internal processes, databases and our relationship with other groups on campus relationship with other groups on campus (IRB, Finance, Departments, etc.).(IRB, Finance, Departments, etc.).We welcome comments, suggestions & We welcome comments, suggestions & feedback (especially if it is positive).feedback (especially if it is positive).

Thank YouThank You