Activity Planning Agreement

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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
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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
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