Office of Continuing Medical Education 1462 Clifton Road, NE, Suite 276 Atlanta, GA 30322 404-727-1626 (telephone) 404-727-5667 (fax) Continuing Medical Education (CME) ACTIVITY PLANNING AGREEMENT between Emory University School of Medicine Office of Continuing Medical Education and COURSE DIRECTOR NAME Certification of a CME activity by Emory University School of Medicine requires that its Office of Continuing Medical Education (OCME) accept responsibility that the Accreditation Council for Continuing Medical Education’s (ACCME) Essential Areas, Accreditation Policies and Procedures and the Standards for Commercial Support are met. Furthermore, Emory University School of Medicine must be able to provide written documentation to the ACCME that demonstrates how each CME activity was planned, implemented, and evaluated in compliance with their policies and procedures. PURPOSE: The purpose of this Agreement between Emory University School of Medicine Office of CME and COURSE DIRECTOR is to clarify their respective roles in the development, implementation and evaluation of the continuing medical education activity, title to be determined to be held DATE. The purpose of this activity is to further the mission of the medical school and Emory CME and provide physicians and other healthcare providers an educational intervention that will attempt to close identified professional practice gaps and positively impact patient health outcomes in measureable ways. UNDERSTANDINGS: It is understood that: 1. COURSE DIRECTOR NAME will serve as Course Director for this activity. As such he/she will obtain approval from his/her chairperson. In addition, he /she will provide a financial system Smartkey number to be used for activity-related expenses and deposits. 2. The Course Director will maintain the scientific integrity and objectivity of its educational content. It shall be his/her responsibility to: Select and confirm Program Dates with OCME at least 9 months prior to activity Meet on a regular basis with OCME staff for program planning; Disclose his/her financial relationships with commercial pharmaceutical and medical device manufacturers via the Financial Relationship Disclosure Form; Select knowledgeable individuals to serve on a planning committee; Document the processes and resources that the planning committee used to identify professional practice gaps and to determine the educational needs of the target audience; State the identified needs and learner objectives as well as how the educational activity will meet the learners’ needs ; Identify appropriate, knowledgeable speakers and in the invitation letters to them, identify the content of their presentation. Collect financial disclosure information from each speaker and planning committee member with the assistance of OCME; Assist OCME with resolving or managing all identified conflicts of interest ; Execute the CME Activity Planning and Approval Form (CAF) and provide the supporting documents, including completed Financial Disclosure Forms from all members of the planning committee and speakers, needs assessment documentation, and Maintenance of Certification/Licensure information; Activity Planning Agreement 1/2012; 3/12; 8/15 Prepare a draft of the program agenda; (Optional) Identify potential Commercial Supporters and Exhibitors with the assistance of OCME; Review final financial statements ; Create an evaluation instrument to assess how well activity met its stated learning objectives, how learners will change their practice as a result of the activity, and whether commercial bias was evident during the activity. 3. The Course Director will provide to the OCME all materials required to document that the activity is developed in compliance with the ACCME Essential Areas and Standards for Commercial Support including Financial Disclosure forms from all speakers, planning committee members and him/herself. Any identified conflicts of interests must be resolved or managed prior to any further participation in the activity. ONLY SPEAKERS AND PLANNING COMMITTEE MEMBERS WHO HAVE NO CONFLICT OF INTEREST OR HAVE HAD THEIR CONFLICT OF INTEREST RESOLVED SHALL BE ALLOWED TO PARTICIPATE. INDIVIDUALS WHO REFUSE TO DISCLOSE ARE DISQUALIFIED FROM PARTICIPATING. EMPLOYEES OF COMMERICAL ENTITIES ARE PROHIBITED FROM PARTICIPATION IN ANY CAPACITY. 4. It is agreed that the Course Director and OCME will adhere to the letter and spirit of the elements set forth in the Emory University School of Medicine policies and guidelines, the ACCME Essential Areas and Standards for Commercial Support, and the AMA Ethical Opinion on Gifts to Physicians as provided at www.accme.org and www.ama-assn.org. 5. The activity faculty must be informed of the activity’s overall educational goals, specific learning objectives, composition of the target audience and the method of instruction. The faculty must agree to comply with all policies on faculty disclosure, disclosure of unlabeled/unapproved uses, fairbalance requirements, honoraria. Faculty should provide curriculum vitae and, if requested, handouts for learners. 6. The advertisement/brochure, containing all appropriate course-related information and language as required by the ACCME Essential Areas, AMA Physician Recognition Award requirements, other professional groups/societies must be reviewed and approved by an OCME professional staff member prior to printing and replication. Such approval shall not be unreasonably withheld. 7. All promotional materials must be reviewed and approved by an OCME professional staff member prior to distribution and/or printing, approval not to be unreasonably withheld, and must contain all appropriate CME information as required by the ACCME Essential Areas and AMA PRA requirements and maintenance of certification/licensure (if applicable). 8. The Course Director and OCME will warrant, to the best of their knowledge, that the use of material or information developed and prepared for this activity will not violate any third party’s copyright. To the extent copyrighted materials are used, any necessary permissions and releases from the copyright owner of such materials will be obtained by the faculty planning to use the material. 9. OCME will work with the Course Director to identify and obtain commercial and other support for this activity. Commercial support includes education grants as well as “in kind donations” such as use of equipment. The terms, conditions and purposes of such support must be documented Letter of Agreement between the commercial supporter and OCME. Without exception, all such Letters of Agreement must be signed by the CME Program Director and the responsible representative of the commercial entity providing the support. All support associated with this activity must be given with the full knowledge and approval of the OCME. No other funds from a commercial source may be directly paid to the director of the activity, faculty, or others involved with the supported activity. 10. The Office of Continuing Medical Education reserves the right to withdraw CME approval for any breach of this Agreement thirty (30) days after written notice has been provided to the Course Activity Planning Agreement 1/2012; 3/12; 8/15 Director. The Course Director will have the opportunity to correct the violation within the 30 day period. 11. The Course Director may terminate this Agreement, at any time, with or without cause, and without liability, except to pay any expenses that may have been generated prior to termination. 12. Specific responsibilities and due dates are attached. Both parties shall agree that failure to meet specified deadlines will jeopardize the success of the activity. ACCEPTED AND AGREED TO: __________________________________________ Signature ___________________________________ Signature ______________________________ Date __________________________________ Date Emory University School of Medicine Department of Continuing Medical Education 1462 Clifton Road, Suite 276 Atlanta, GA 30322 Phone: 404 -727-1626 Fax: 404-727-5667 E-mail: mboone2@emory.edu Activity Planning Agreement 1/2012; 3/12; 8/15 Course Director Date Due OCME Date Due Meet with OCME for Program Planning (minimum 9 months prior to proposed activity date) Venue and date selection Gather basic information about the activity Form a Planning Committee, get financial disclosures, resolve conflicts of interest Identify target audience Identification of performance gaps and needs Documentation of needs assessment resources Identify possible commercial supporters or exhibitors (optional) Submit CME Activity Planning and Approval Form (CAF) with supporting documents (minimum 6 months prior to proposed activity date): Tentative agenda Formulate learning objectives for the activity and each session List of proposed faculty with titles, addresses, affiliation etc. Needs assessment data Financial Disclosure forms of speakers Execute Hotel/Venue Contract (if applicable) - upon approval of CAF Review ALL Financial Disclosure forms for conflict of interest; Begin procedures to resolve and/or manage the conflicts of interest Confirm participating speakers/faculty (ONLY SPEAKERS AND PLANNING COMMITTEE MEMBERS WHO HAVE NO CONFLICT OF INTEREST OR HAVE HAD THEIR CONFLICT OF INTEREST RESOLVED SHALL BE ALLOWED TO PARTICIPATE. EMPLOYEES OF COMMERICAL ENTITIES ARE PROHIBITED FROM PARTICIPATION) Prepare activity budget Prepare draft of the program agenda Confirm mailing list (if applicable) Approve brochure/promotional materials for printing/publication Mail/publish brochure/promotional materials Develop an evaluation form to assess whether learning objectives have been met, whether there was commercial bias, and whether the learners have gained knowledge or new skills and as a result, how will they change their practices Review final financial statements Agreed to by: _______________________________ Course Director Activity Planning Agreement 1/2012; 3/12; 8/15 ___________________________________ CME Coordinator