The Contracting Process (Why Does it Take So Long?) Libby Salberg, Associate Director Beth Watkins, Contract Analyst, Team Manager Janet Fry, Manager Clinical Research Facilitation Office of Grants and Contracts Management

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

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

Mechanics of Our Research Contract Process Step 1 – Receive and assign contract Step 2 – Negotiation Step 3 – Finalization & Execution Step 4 – Follow-up

Step 1 Receive and Assign Contract New contracts should be sent to as part of a complete package - PI & Dept. Contact; Copy of Protocol; External Contact Info, Contract as supplied by sponsor, signed transmittal form and budget (draft version is acceptable) New Contracts will be assigned to a Contract Analyst within 24 hours of receipt. Dept.contact and PI will receive an notifying them of Contract Analyst assigned.

Hospital Finance Approval While contract is under review and as soon as ready, submit; Project Information Sheet Clinical Research Budget Grid Clinical Trial Registration Form Informed Consent Document GCM will use these forms to obtain necessary approval from Department of Finance.

Step 2 Negotiation: General Information Goal is to have a response to the External Party within 15 business days. Contract Analyst reviews agreement and determines whether terms need to be modified for pragmatic or policy reasons in accordance with Vanderbilt Guidelines. Goal is not to have a perfect agreement but to have one in keeping with Vanderbilt’s guidelines. In course of review, CA may have questions for the department, PI, University Counsel, Technology Transfer or Risk Management. PI and Department will be copied on all correspondence from Contract Analyst. Budgets and payment terms are negotiated by the department, not OGCM. Janet Fry, Manager of Clinical Research Facilitation, is available to assist you with budget development and negotiation. Phone or

Step 2 Negotiation: Checklist, Sample Items Document retention NoticesAmendments Conflict of terms HIPAA Document Retention InsuranceTermination Confidential information Intellectual property Indemnification Subject injury BillingPublications Use of results

Step 2 Negotiation: Why does it take so long? Difference between what they offer & what Vanderbilt requires/needs Main areas of contention: Confidentiality Confidentiality Intellectual Property Intellectual Property Indemnity Indemnity Subject Injury Subject Injury Master Agreements

Step 2 Negotiation: Impasse Team Leaders, as well as Associate Director and Director, are available to consult. If Sponsor is insisting upon language outside of guidelines, contract issue is brought to DCM (Difficult Contracts Meeting). General factors weighed are nature of research, size of budget, and then particulars depending on issue (e.g. chance of IP arising from contract). Dr. Gordon Bernard, Assistant Vice-Chancellor for Research, is arbiter in such cases.

Step 3 Contract Finalized & Executed Department is notified. Originals sent to OGCM for final proof- reading & then routed to PI for signature. OGCM will return originals to Sponsor & will keep original for VUMC and send a copy to Department.

Step 4 Follow-up Annual review to determine if contract needs to be terminated or extended. Amendments

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

Thank You