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

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
[email protected] 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 email 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 -65886 or email
[email protected]
Step 2
Negotiation: Checklist, Sample Items
Document retention
Notices
Amendments
Conflict of terms
HIPAA
Document Retention
Insurance
Termination
Confidential information
Intellectual property
Indemnification
Subject injury
Billing
Publications
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:
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•
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Confidentiality
Intellectual Property
Indemnity
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 proofreading & 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