VANDERBILT SCHOOL OF MEDICINE

Division of Continuing Medical Education

Letter of Agreement (LOA) for Commercial Support of CME

This agreement, by and between the Vanderbilt School of Medicine (herein after referred to as the “accredited sponsor”) and ((______)) (herein after referred to as the “commercial supporter”) is intended to clarify the responsibilities of each party with respect to the CME activity described below (that will be referred to as the “CME offering”).

Name of CME Offering
Date of CME Offering
Location of CME Offering
Purpose and amount/value of grant / / unrestricted educational grant. Amount: $
/ in-kind support. Estimated value: $

Checks should be made payable and sent to:

Vanderbilt Division of CME

ATTN: Nanette Bahlinger

320 Light Hall

Nashville, TN 37232-0260

In connection with the contribution described above, the individuals whose signatures appear below agree to statements 1 through 22 of this agreement in the planning and conduct of the CME offering.

Commercial Supporter / Name:
Title
Signature /

Date

Vanderbilt School of Medicine:
Division of CME / Name: / Donald E. Moore, Jr., PhD
Title / Director, Division of Continuing Medical Education
Signature /

Date

  1. The activities of the accredited sponsor of this CME offering are governed by the Essentials Areas and Policies of the Accreditation Council for CME as well as the Guidelines for Commercial Support of CME of the accredited sponsor.

2.All representatives of the commercial supporter will comply with all provisions of the above documents before, during, and after the conduct of this CME offering;
3.The CME offering is for scientific and educational purposes only and will not promote the products of the commercial supporter, directly or indirectly.
4.The accredited sponsor is ultimately responsible for control of content and the commercial supporter, or its agents, will not attempt to influence the content of the CME offering through “scripting” of presentations or other means.
5.The accredited sponsor is ultimately responsible for selection of presenters and moderators at the CME offering. The commercial supporter, or its agents, will respond only to initiated requests of the accredited sponsor for suggestions of presenters or sources of possible presenters. The commercial supporter will suggest more than one name (if possible); will provide speaker qualifications; will disclose financial or other relationships between commercial supporter and speaker, and will provide this information in writing. The accredited sponsor will record the role of the commercial supporter, or its agents, in suggesting presenter(s); will seek suggestions from other sources, and will make the selection of presenter(s) based on a balanced and independent interpretation of the requirements of the CME offering.
6.The accredited sponsor will ensure that the following information is disclosed to the audience at the CME offering: (a) funding support of the commercial supporter; (b) any significant relationship(s) between individual faculty members and the commercial supporter.
7.The support provided by the commercial supporter will be acknowledged in printed announcements and brochures designed to promote this CME offering, if this signed agreement is received before the printing deadline.
8.No product promotional activities by the commercial supporter will be permitted on campus or in the same room as the CME offering for off campus events. No advertisements for the commercial supporter’s product will be permitted. Permissible educational materials include information about new medical equipment and/or devices, clinical trials investigating drugs relevant to the topic of the course, and scientific efficacy studies. The materials should be free of company logos, if possible.
9.The accredited sponsor will make every effort to ensure that data regarding the commercial supporter's products (or competing products) are objectively selected and presented, with favorable and unfavorable information and balanced discussion of prevailing information on the product(s) and/or alternative treatments.
10.The accredited sponsor will ensure, to the extent possible, disclosure of the limitations of the data presented in the CME offering (e.g. ongoing research, interim analyses, preliminary data, or unsupported opinion).
11.The accredited sponsor will ensure opportunities for questioning or scientific debate.
12.The accredited sponsor will require that presenters or moderators in the CME offering disclose when a product is not approved in the United States for the use under discussion.
13The funding support for this CME offering will be provided in the form of an educational grant managed by the Division of Continuing Medical Education or its designee.
14.The funding will be provided through a check made payable to the Vanderbilt Division of CME (tax identification number: 620476822), or to its designee.
15. Only the Vanderbilt School of Medicine is authorized to make travel and lodging arrangements for the speaker, unless an agreement stipulating other arrangements is made beforehand.
16. Only the Vanderbilt School of Medicine is authorized to reimburse the speaker for expenses or pay honorarium, unless an agreement stipulating other arrangements is made beforehand.
17. The funds provided in the educational grant will be used only to support the CME offering and these funds will be used to pay honorarium and reimburse reasonable expenses incurred by speakers, such as airfare, lodging, food, local transportation, and other expenses.
18.The Division of Continuing Medical Education at Vanderbilt will be informed about and approve all other support associated with this CME offering;
19.No other funds from the commercial supporter will be paid to the program director, faculty, attendees, or others involved with the CME offering (e.g., additional honoraria, extra social events, etc.).
20.The accredited sponsor, upon request, will furnish the commercial supporter with a report concerning the expenditure of the funds provided.
21.Monitoring of the CME activity by the Vanderbilt Division of CME and/or commercial supporters is allowed. Monitors from Vanderbilt Division of CME will be on-site as deemed necessary by Vanderbilt. Monitors from the compliance arm of the commercial supporter will be allowed upon request made to Vanderbilt Division of CME; these monitors will be silent observers who will not assume other roles, such as managing exhibit space. Registration fees for monitors will be waived. All other expenses incurred by the monitor from the compliance arm of the commercial supporter will be paid for by the commercial company.
22.The accredited sponsor or the commercial supporter has the right to terminate this agreement on thirty (30) days written notice to the other party. In the event of such termination, the commercial supporter shall be responsible for paying to the accredited sponsor only those amounts actually spent, or irrevocably committed, by the accredited sponsor with respect to the CME offering. In the event that accredited CME provider terminates this Agreement and/or event, accredited CME provider shall provide commercial supporter with an accounting of all expenditures and shall reimburse to commercial supporter any portion of Educational Grant which has not been actually spent or irrevocably committed to.

2/2011