COURSE DIRECTOR MANUAL Continuing Education 2013 Sharon K. Whitmer, EdD, MFT CMDA Accreditation Officer 2 TABLE OF CONTENTS Christian Medical & Dental Associations Continuing Education Mission Statement Page 3-4 A) Continuing Education Committee Policy 1.0 – Continuing Education Committee Members Page 5 Page 6 Policy 2.1 - Expenditures and Income for an Activity Page 7 Policy 2.2 - Joint Sponsorship Page 8-9 Policy 2.3 – Direct Sponsorship Page 10-11 Policy 2.4 - Social Events Page 12 Policy 2.5 - Photography at CMDA CE Activities Page 13 Page 14 Policy 3.1 – Disclosure Page 15 Policy 3.2 - Identification and Resolution of Conflicts of Interest Page 16 Policy 3.3 - Methods of Content Validation and Verification Page 17 Page 18 Page 19-20 Page 21-32 Promotional Content for a CMDA CE Activity Page 33-34 Disclosure Form Page 35 CMDA Conflicts of Interest Resolution Page 36 Commercial Exhibitor Form Page 37-38 ACCME Standards for Commercial Support Page 39-41 AGD Standard XII Commercial or Promotional Conflict of Interest Page 42-43 B) Conference Policies Policy 2.0 - Application and Approval of AMA PRA Category 1 CreditTM And AGD PACE Credit C) Faculty/Speaker/Presenter Policies Policy 3.0 - Course Director/Planner & Presenter Honorariums/Reimbursements D) Commercial Support and Booth Space Policies Policy 4.0 – Commercial Support Policy 4.1 –Non-commercial and Commercial Exhibitors E) FORMS CE Application 3 MISSION The mission of Christian Medical & Dental Associations (CMDA) Continuing Education (CE) Department is to: assist physicians, dentists and other health care professionals in the content translation, diffusion, and application of evidence-based knowledge; support the CMDA institutional mission of partnering with national and international organizations to provide education to health care professionals and meet the physical, emotional and spiritual needs of patients by eliminating barriers and developing and implementing strategies to identify and narrow professional practice gaps by changing the learners’ knowledge, competence and performance in order to change patient outcomes. Purpose: CMDA CE has four purposes. First, provide educational resources, networking opportunities, medical missions, and a voice for Christian health care professionals through collaboration with the Christian Medical & Dental Associations’ stakeholders. Second, identify professional practice gaps; and design, deliver, evaluate and document educational activities and initiatives to change health care professionals’ competence, performance and patient outcomes for the purpose of improving the health and welfare of patients. Third, provide a forum for the challenges faced by Christian healthcare professionals concerning bioethics, rights of conscience and other controversial topics. The Christian Medical & Dental Associations’ stakeholders include its members, physicians, dentists and other health care professionals practicing in missions regionally, nationally and internationally. Fourth, build collaborations with national and international organizations including ministries of health, hospitals, universities and others. Content Areas: The CMDA CE will develop educational content and strategies to change physician, dentist and other health care professionals’ knowledge, competence and performance in order to improve the health and welfare of patients. In addition, CMDA will assist in making practice and system changes in the health care delivery environment. Target Audience: CMDA CE will serve two primary audiences, internal and external. The internal audience includes professional staff, affiliated health care organizations and health care professionals. For the internal audience, CE will play a critical role within CMDA for education, providing Category 1 Credits, AGD Credits as well as other credits, and participating in improving the health and welfare of patients through partnerships with the CE Committee initiatives. The external audience consists of a broad population of national and international health care providers, administrators, and others who impact the health of patients beyond the CMDA stakeholders. Types of Activities: 1. Educational Activities: The primary strategy for accomplishing the mission will be the development and implementation of a range of educational activities. These activities will be developed around specific needs related to gaps in knowledge, competence and performance. They will be delivered in a 4 variety of formats, including, live events (e.g., lectures, workshops, and seminars) and enduring materials. 2. Identification of Barriers to Change: As part of the activity planning, activity planners will identify barriers to change, recommend and implement into activities ways to overcome those barriers. The activity evaluation will assess the level of change resulting from the educational intervention. 3. Interdisciplinary Team Approach to Education: Improving the health of patients requires the education and participation by a variety of health care professionals and others. Educational interventions will include a variety of professionals and stakeholders in the educational activities in order to promote change and improvements. 4. Partnerships and Alliances: CMDA will partner with a variety of organizations, and other groups whose missions overlap with the CMDA/CE. Some of these include: quality improvement organizations/departments, administrators, educational institutions, patient advocacy groups, relief organizations and others. 5. Non-educational tools and strategies for change: As an adjunct to educational programming, CMDA will develop and disseminate non-educational tools and resources that facilitate changes in competence, performance and changes to patient care. 6. Physician competencies and desirable physician attributes: As part of its planning, the CMDA will incorporate the Maintenance of Certification (MOC) competencies designed by the American Board of Medical Specialties (ABMS), the competencies established by the Accreditation Council for Graduate Medical Education (ACGME), and the desirable physician attributes established by the Institutes of Medicine (IOM) these include: patient care, medical knowledge, practice-based learning and improvement, systems based practice, professionalism, interpersonal skills and communication, Interdisciplinary Teams, quality Improvement and Utilization of Informatics. Expected Results: CMDA will utilize evaluations and outcome surveys that encourage learner selfassessment and self-directed decisions that will encourage changes and make improvements in health care practices. A follow-up outcomes survey will include an open-ended question on patient outcomes (no patient identification) and will be used to measure changes in competence, performance and patient outcomes. Both instruments will provide data on the impact of the educational activities, overall Program and drive an ongoing quality improvement process within CE. Where possible, assessment of patient care indicators or other data will be used to provide objective insight into the impact of the educational activities. CMDA expects results to demonstrate changes in competence, performance and patient outcomes as a result of its educational interventions and the impact and scope of its overall CE program. Approved by Christian Medical & Dental Associations CE Advisory Committee / Board of Trustees – September 2013 5 Policy 1.0 Policy Name: Continuing Education Committee Members CE Committee Approval Date May 2010 Revision Date Revision Date Revision Date May 2011 April 2012 Sept 2012 Revision Date Revision Date Policy (from Board Policy Manual 2.19.6) The Continuing Education Committee (CE Committee) insures that all of the requirements of the Accreditation Council for Continuing Medical Education, the Academy of General Dentistry and the CMDA/CE Mission are achieved. With consideration to recommendations for the Committee, the Chair and Committee Member appointments will be made by the CMDA President and ratified by the Board of Trustees. The term of appointment is two years with option of renewal without limit. Procedure 1) Committee members will complete a disclosure annually. No one will be permitted to serve on the Committee if they refuse to disclose. A member who has a conflict of interest concerning a CE educational activity will recues them self from reviewing that activity. 2) If a Committee member elects to discontinue service, another Committee Member will be appointed. 3) If a Committee member does not attend meetings or review applications for one fiscal year, the member will be released from the committee. This does not apply to members who notify the Department of Continuing Education of mitigating circumstances in writing and still perform tasks such as reviewing applications and presentations. 6 Policy 2.0 Policy Name: Application and Approval of AMA PRA Category 1 CreditTM and AGD PACE Credit CE Committee Approval Date May 2010 Revision Date Revision Date Revision Date May 2011 April 2012 Sept 2012 Revision Date Revision Date Policy Activities must be reviewed and approved by the CMDA CE Committee. Procedures The activity director/planning committee will work with the CE Director and the CMDA Accreditation Officer to complete the following: 1) Disclosures from planners prior to planning an activity. 2) Resolution of Conflicts of Interest prior to planning an activity. 3) Completion of the activity application. 4) Budget for the activity. 5) Once the planning of the activity is completed, the CE Director will submit the application to the CMDA/CE Committee for review and determination of approval or denial of CMDA sponsorship for the CE activity. 7 Policy 2.1 Policy Name: Expenditures and Income for an Activity CE Committee Approval Date May 2010 Revision Date Revision Date Revision Date Revision Date May 2011 April 2012 Sept 2012 Jan 2013 Revision Date Policy Expenses and income for all CMDA/CE activities must be submitted to the CE director. Procedures 1) No expenses for an activity will be paid if the expenses were not approved by the CMDA/CE Committee. 2) If CMDA pays all the expenses for an activity; any remaining proceeds will be transferred to a departmental account or educational partner. No remaining funds will be paid directly to a course director or planning committee member(s). 3) Direct and Joint sponsorships that are designated by CMDA to manage the income and expenses will submit documentation and a financial wrap-up of income and expenses for the activity. 4) CMDA will not sponsor or joint sponsor a CE activity that is commercially supported. 5) CMDA will sponsor CE activities that are supported by commercial exhibitors as long as commercial exhibitors complete the Commercial Exhibitor Form and follow ACCME Standards for Commercial Support and the CMDA Guidelines. 8 Policy 2.2 Policy Name: *Joint Sponsorship CE Committee Approval Date May 2010 Revision Date Revision Date Revision Date Revision Date May 2011 April 2012 Sept 2012 Revision Date Jan 2013 Policy The CMDA Department of Continuing Education will enter into joint sponsorships. Procedures 1) The planner(s) will complete the CMDA disclosure form and any conflicts of interest will be identified by the CE Director and the CMDA Accreditation Officer and resolved according to the CMDA Procedures for Resolving Conflicts of Interest. 2) No commercial support will be given to CMDA/CE sponsored or jointly sponsored activity. Therefore, CMDA will not provide or sign a Letter of Agreement and a commercial interest cannot require (as a condition of contributing funds or services) that they be allowed to provide advice or services concerning content, teachers, authors, participants, logistics or any other educational activity matter. 3) Since CMDA does not accept commercial support, exhibit space cannot be offered as part of receiving an educational grant; however exhibit space may be acquired by commercial entities at some CMDA/CE activities for a fee through the event manager. 4) The planner(s) will work with the CMDA Accreditation Officer to complete the Application and insure that the activity has been planned in compliance with the ACCME Criteria, Standards for Commercial Support and the policies and procedures of the CMDA. 5) Once the planning of the activity is completed, the CE Director will submit the application to the CE Committee for review and determination of approval or denial of CMDA joint sponsorship for a CE activity. 6) Jointly sponsored CMDA/CE activities will adhere to the following: A) CMDA must approve all materials prior to printing. B) Activity evaluation, outcomes survey and welcome letter will be prepared by CMDA. C) CMDA will provide provisions for attendance reporting. D) Appropriate wording and usage of the Accreditation, Credit Designation statements, and Logo use. E) Delineation of the role of the CMDA staff in planning and executing the activity. F) Submit documentation and financial wrap-up of income and expenses. G) Provide sign-in sheets and any other documents deemed necessary by the CMDA. H) Social events or meals at the activity cannot compete with or take precedence over the Educational activity. I) Honorarium and out-of-pocket expenses may be paid directly to the teacher or author, However documentation of the payment must be provided to the CMDA. J) No payment or reimbursement of expenses will be made to the learners. 9 K) If a teacher or author is listed on the agenda as facilitating or conducting a presentation, they May receive honorarium and reimbursement of expenses for that portion of their Participation. If they choose to be a learner for the reminder of an activity; they cannot Receive any payment for learner participation. L) No other payment may be provided to the directors, planners, presenters, joint sponsors, Learners or any others involved with the CMDA/CE activity. PLEASE NOTE: CMDA is not approving jointly sponsored activities that are supported by commercial entities, however commercial exhibitors are permissible. *Jointly sponsored CE activity is one that is planned and implemented by CMDA and an organization that is not accredited by the ACCME nor approved as a PACE provider. 10 Policy 2.3 Policy Name: *Direct Sponsorship CE Committee Approval Date May 2010 Revision Date Revision Date Revision Date Revision Date May 2011 April 2012 Sept 2012 Jan 2013 Revision Date Policy The CMDA Department of Continuing Education will enter into direct sponsorships. Procedures 1) The CMDA planner(s) will complete a disclosure form and any conflicts of interest will be identified by the CE Director and the Accreditation Officer and resolved according to the CMDA Procedures for Resolving Conflicts of Interest. 2) No commercial support will be given to the activity. Therefore, CMDA will not sign a Letter of Agreement and a commercial entity has no rights regarding (as a condition of contributing funds or services) advice or services concerning content, teachers, authors, participants, logistics or any other educational matter. 3) Since CMDA does not accept commercial support, exhibit space cannot be offered as part of receiving an educational grant; however exhibit space may be acquired by commercial entities at some CMDA/CE activities for a fee through the event manager. 4) The planner(s) will work with the CMDA Accreditation Officer to complete the Application and insure that the activity has been planned in compliance with the ACCME Criteria, Standards for Commercial Support and CMDA policies and procedures. 5) Once the planning of the activity is completed, the CE Director will submit the application to the CMDA/CE Committee for review and determination of approval or denial of CMDA sponsorship for the CE activity. 6) Direct sponsorships will adhere to the following: A) No Commercial support for the activity. B) CMDA/CE must approve all materials prior to printing. C) Activity evaluation, outcomes survey and welcome letter will be prepared by CMDA. D) CMDA will provide provisions for attendance reporting. E) Appropriate wording and usage of the Accreditation, Credit Designation statements, and Logo use. F) Delineation of the role of the CMDA staff in planning and executing the activity. G) Submit documentation and financial wrap-up of income and expenses. H) Social events or meals at the activity cannot compete with or take precedence over the Educational activity. I) Honorarium and out-of-pocket expenses may be paid directly to the teacher or author, however Documentation of the payment must be provided to the CMDA CE Director. J) No payment or reimbursement of expenses will be made to the learners. 11 K) If a teacher or author is listed on the agenda as facilitating or conducting a presentation, they May only receive honorarium and reimbursement of expenses for that portion of their Participation. If they choose to be a learner for the reminder of an activity, they cannot Receive payment. L) No other payment may be provided to the directors, planners, presenters, joint sponsors, Learners or any others involved with the supported activity. PLEASE NOTE: CMDA does not approve direct sponsored CE activities that are supported by commercial entities; however CMDA does sponsor CE activities that are supported by commercial exhibitors. *A directly sponsored activity is one that is planned and implemented by CMDA, which includes its Commissions. 12 Policy 2.4 Policy Name: Social Events CE Committee Approval Date May 2010 Revision Date Revision Date May 2011 April 2012 Revision Date Revision Date Revision Date Policy The CMDA Department of Continuing Education does not plan or arrange social events. Procedure Upon request, Continuing Education staff will provide names and contact information of event planners to course directors/planning committees. 13 Policy 2.5 Policy Name: Photography at CMDA CE Activities CE Committee Approval Date May 2010 Revision Date Revision Date May 2011 April 2012 Revision Date Revision Date Revision Date Policy Photography may be used at a CMDA direct or jointly sponsored CE activity by adhering to the following procedures: Procedures 1) Photographs of participants and speakers are allowed at CMDA direct or jointly sponsored CE activities. 2) Photographs of patients serving as demonstrators or speakers; and a speaker’s slides cannot be Photographed. This includes photos by a camera, cell phone, videos or other electronic photography Devices. 14 Policy 3.0 Policy Name: Course Director/Planner & Presenter Honorariums/Reimbursements CE Committee Approval Date May 2010 Revision Date Revision Date May 2011 April 2012 Revision Date Revision Date Revision Date Policy Honorarium and reimbursement expenses are paid by the CMDA CE Department, a CMDA affiliate or a joint sponsor designated by the CE Director. If honorarium and/or reimbursement expenses are paid by an entity other than the CMDA CE Department, documentation of those payments must be submitted to the CE Department. Procedures 1) Honorarium and reimbursements of out-of-pocket expenses are paid by CMDA, its educational partner or joint sponsor directly to course directors, teachers, authors and/or presenters and in compliance with the ACCME Standards for Commercial Support and the CMDA written policies and procedures. 2) If the honorarium and reimbursements are paid by the educational partner, CMDA must have documentation of the payment. No other payment will be paid to course directors, planning members, teachers, authors, presenters, joint sponsors, or any others involved in the (CMDA does not accept commercial support) educational activity. 3) Honorarium and out-of-pocket expenses are paid for planning, conducting, facilitating and presenting. Reimbursement 4) If planners, teachers, authors and presenters participate in the remainder of an educational activity as a learner, their expenses cannot be reimbursed and honorarium is paid only for their role as a planner, teacher, author and/or presenter. No honorarium or reimbursement of expenses is paid to a learner. 5) No direct payment from an ACCME-defined commercial interest is given to the director of an activity, any planning committee member, teacher, author, joint sponsor or any others involved in a CMDA CE activity. 15 Policy 3.1 Policy Name: Disclosure CE Committee Approval Date May 2010 Revision Date Revision Date Revision Date May 2011 April 2012 Jan 2013 Revision Date Revision Date Policy All persons involved in planning, implementing, coordinating, presenting, and/or authoring a CMDA CE activity must complete a disclosure form. Procedures 1) Everyone (including immediate family members) who are in a position to control the content of an Educational activity must disclose all relevant financial relationships with a commercial interest. 2) Should it be determined that a conflict of interest exists as a result of a financial relationship, the Conflict must be resolved prior to participating as a planner, implementer, coordinator, presenter and/or Author of a CE activity. 3) Failure to complete a disclosure form disqualifies a person from being a planner, implementer, Coordinator, presenter and/or author and they may not have any involvement in the content of a CMDA CE activity. 4) Information regarding individuals who have no relevant financial relationship(s) is reported to the Learners. 16 Policy 3.2 Policy Name: Identification and Resolution of Conflicts of Interest CE Committee Approval Date May 2010 Revision Date Revision Date Revision Date Revision Date May 2011 April 2012 Sept 2012 Jan 2013 Revision Date Policy Conflicts of Interest (COI) will be identified by the CE Director and the Accreditation Officer and resolution of the conflict will occur before anyone is allowed to plan, coordinate, implement, present and/or author a CE activity. Procedure 1) If a conflict of interest is identified from the disclosure form by the CE Director and the Accreditation Officer, the individual must adhere to the CMDA Conflict of Interest Resolution. See The CMDA Conflict of Interest Resolution in this Manual. 2) Failure to adhere to the CMDA Procedures for Resolving Conflicts of Interest will result in Exclusion from planning, coordinating, implementing, authoring and NO Category 1 CreditTM or AGD PACE approval for a presentation. 17 Policy 3.3 Policy Name: Methods of Content Validation and Verification CE Committee Approval Date May 2010 Revision Date Revision Date Revision Date Revision Date May 2011 April 2012 Sept 2012 Jan 2013 Revision Date Policy The CMDA Continuing Education Department will document content validation and verification. Procedures Course directors will read the following statements on the planning application and faculty will read these statements on the disclosure form and use a check mark to attest to the following: 1) All recommendations involving clinical medicine in a CE activity are based on Scientific evidence that is accepted within the profession of medicine as adequate justification for their Indications and contraindication in the care of patients. 2) All scientific research referred to, reported on, or used in this CE activity will support or justify Patient care recommendations that conform to the generally accepted standards of experimental design, Data collection and analysis. 3) The content of this activity will be based on evidence that constitutes “best practices.” The CE Committee members will: 1) Review the educational activity application and validate and verify the content before approving that CMDA will sponsor or jointly sponsor a CE activity. 18 Policy 4.0 Policy Name: Commercial Support CE Committee Approval Date May 2010 Revision Date Revision Date Revision Date May 2011 April 2012 Jan 2013 Revision Date Revision Date Policy CMDA does not sponsor or joint sponsor CE activities that are commercially supported. Procedures 1) CMDA will notify the ACCME should it decide to accept commercial support. 2) If CMDA decides to accept commercial support, see the “Forms” section of this Manual for an example of the CMDA Letter of Agreement. 3) If CMDA decides to accept commercial support, it will adhere to the ACCME Standards for Commercial Support. 19 Policy 4.1 Policy Name: Non-commercial and commercial Exhibitors CE Committee Approval Date May 2010 Revision Date Revision Date Revision Date May 2011 April 2012 Jan 2013 Revision Date Revision Date Policy CMDA will accept both non-commercial and commercial exhibitors for sponsored and joint-sponsored CE activities. Definitions Commercial Support Commercial Support for a CE activity is financial or in-kind contributions given by a commercial interest, which is used to pay all or part of the costs of a CE activity. Commercial Interest Commercial interest is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. Non-commercial Interest Non-commercial interest provide clinical services directly to patients, such as hospitals, health systems, medical group practices, blood banks, and diagnostic laboratories, are an integral component of accredited CME and CDE because they represent the provision of CE by the profession for the profession. Therefore, these entities have been deemed NOT to be commercial interests. Procedures 1) Commercial Exhibitors must complete the exhibit form (see exhibit form in this Manual) 2) Commercial interests are not eligible for ACCME accreditation or AGD PACE Approval. Commercial interests cannot be accredited or PACE approved providers and cannot be joint sponsors. 3) Arrangements for commercial exhibits or advertisements cannot influence planning or interfere with the presentation, nor can they be a condition of the provision of commercial support for CME activities (CMDA does not accept commercial support for CE activities). 4) Product-promotion material or product-specific advertisement of any type is prohibited in or during CE activities. The coincidence of editorial and advertising material on the same products or subjects must be avoided. Live (staffed exhibits, presentations) or enduring (printed or electronic advertisements) promotional activities must be kept separate from CE. There will be no ‘commercial breaks.’ For live, face-to-face CE, advertisements and promotional materials cannot be displayed or distributed in the educational space immediately before, during, or after a CE activity. CMDA will not allow representatives of Commercial Interests to engage in sales or promotional activities while in the space or place of the CE activity. 5) Print advertisements and promotional materials will not be interleafed within the pages of the CE content. Advertisements and promotional materials may face the first or last pages of printed CE content as long as these materials are not related to the CE content they face and are not paid for by the commercial supporters of the CE activity (CMDA does not accept commercial support for CE activities). 6) Computer based advertisements and promotional materials will not be visible on the screen at the same time as the CE content and not interleafed between computer ‘windows’ or screens of the CE content. Audio and video recording advertisements and promotional materials will not be included within the CME. 20 7) Print or electronic information distributed about the non-CE elements of a CE activity that are not directly related to the transfer of education to the learner, such as schedules and content descriptions, may include product-promotion material or product-specific advertisement. 8) CMDA will not use a commercial interest as the agent providing a CE activity to learners, e.g., distribution of self-study CE activities or arranging for electronic access to CE activities. 9) CMDA will ensure that their learners can participate in educational activities without seeing, reading or hearing promotional or marketing information from commercial interests. In addition, CMDA will ensure that the selling of advertising or exhibit space is a business transaction entirely separate from the acceptance of commercial support for accredited CME or CDE by refusing to accept commercial support for CMDA educational activities. 10) CMDA follows the policies of the ACCME and the AGD by insisting on the separation of education from all promotional activities, materials and messages. CMDA may create a print or text based document that goes along with an activity and provides information that is supplementary to the educational content - like reproductions of slides, graphics, thumb drives or other handouts. These documents, in print or electronic, are an integral part of the education and as such will not have any advertising, trade name or a product-group message associated with them. 11) If a commercial interest seeks to purchase advertising and promotional opportunities with resources designated for that purpose and an agreement for advertising and promotion between CMDA and the commercial interest is established, CMDA will not accept commercial support and no written agreement for commercial support will be considered. Any event or product that contains advertising or promotional opportunities will not be part of the educational CE activity and must not be paid for by commercial support and the advertisement and/or promotional opportunity will be assigned to the "exhibit hall." Advertising pages or screens or promotional receptions or meals will be clearly identified as such to the learner by CMDA. 12) Promotional events at CMDA CE activities (e.g., exhibit halls) are kept distinct and separate from CE activities by not only their location and time in the program schedule, but also in how these events are clearly described as "Promotional" to CMDA learners. 21 For Office Use Only 11/2013 CHRISTIAN MEDICAL & DENTAL ASSOCIATIONS Planning Document & Application for CME Category 1 credit™ X DISCLOSURES OF THE COURSE DIRECTOR, COURSE CONTACT PERSON AND PLANNING COMMITTEE MUST BE COMPLETED, SIGNED AND E-MAILED TO Barbara@cmda.org BEFORE BEGINNING THE PLANNING. ANYONE WHO REFUSES TO COMPLETE A DISCLOSURE FORM CAN NOT PARTICIPATE IN THE PLANNING, EXECUTION OR PRESENTATION OF A CMDA EDUCATIONAL ACTIVITY. Christian Medical & Dental Associations (CMDA) retains the right to withhold/adjust credit at any time, should it determine that the ACCME Criteria, Policies, ACCME Standards for Commercial Support and/or Christian Medical & Associations policies and procedures are violated. Requirements for Certification by Christian Medical & Dental Associations: Please read and check that you have read them. ___In order to be considered for sponsorship or joint-sponsorship, completion of this application is required and emailed to Barbara@cmda.org two months prior to your activity date. REMEMBER: You can NOT promote CME until the application is approved. Incomplete applications cannot be reviewed or approved by the CMDA Committee, which has the final decision on all applications for Continuing Medical Education, dental and other healthcare professional credits. ___The content of your application must meet: ACCME Criteria, Policies, and Standards for Commercial Support The American Medical Association (AMA) requirements and The CMDA policies and procedures (Go to www.cmda.org/CE) ___HIPPA compliance is the responsibility of the course director ___Recommendations involving clinical medicine in a CME activity are based on scientific evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients. ___Recommendations must conform to the generally accepted standards of experimental design, data collection and analysis ___All scientific research referred to, reported on, or used in this CME activity will support or justify patient care recommendations that conform to the generally accepted standards of experimental design, data collection, and analysis. 22 ___Christian Medical & Dental Associations maintains full oversight and responsibility for the planning, completion of the application and the educational activity Screening Criteria: In order to be considered for continuing medical education credit, all of the criteria listed below must be met. Planner confirms that: ___The content of this activity will be based on evidence that constitutes “best practices” ___Planners have identified a defined professional practice gap(s) that exists between current and best practices ___This activity will provide educational content aimed at closing the defined professional practice gap(s) to result in changed patient health by changing participants’ knowledge, competence, performance and/or practice List any prerequisite knowledge/skill required for attending this activity__________________________________________________________________________ COURSE OVERVIEW 1) School/organization/department making request: 2) Direct-sponsored (Organization within the CMDA) Joint-sponsored (Organization outside of CMDA) 3) Title of course: 4) Course date(s): 5) Course location (include street address, city, state): 6) Please provide a one or two paragraph description of your course. This statement will be used for promotional materials (brochures, web pages, etc.) a needs assessment, and/or to obtain additional professional credits. The description should give an overview of the course and let potential attendees know why this course is an important one for them to attend: 7) Number of CME Credits Requested (hours): 8) Indicate all professional credits being sought for this course. (A Dental Application is required to receive AGD PACE credit): ___ CME CDE (additional fee & Dental Application must be completed) AAFP (additional fee) Nursing (additional fee) In order for CMDA to apply for nurse practitioner credit, you must submit speaker Bio sketches, speaker & planner disclosures and speaker abstracts with this application two months prior to your conference Nurse Practitioner (additional fee) - In order for CMDA to apply for nurse practitioner credit, you must submit speaker Bio sketches, speaker & planner disclosures and speaker abstracts with this application two months prior to your conference Physician Assistant (additional fee) 23 COURSE PLANNERS AND FACULTY 9) 10) Name of Course Activity Director: E-mail: Telephone: FAX: Name of Course/Activity Coordinator (contact person): E-mail: Telephone: FAX : 11) Planning Committee Member – Please list individuals who are planning committee member(s). Planning Committee Member Telephone Number Barbara Snapp, CE Director Sharon K. Whitmer, EdD, MFT Accreditation Officer CE Committee Members E-mail Address barbara@cmda.org sharon.whitmer@cmda.org On file 12) Who are the proposed faculty for this activity? MANDATORY: List confirmed and nonconfirmed faculty. You must include their name & credentials, business title, E-mail address & whether honorarium and travel expenses will be paid to faculty. Name and credentials (MD, PHD, etc.) Business title, institutional affiliation & location example: Professor of Medicine University of Education Mayberry, FL E-mail address Will honorarium and/or travel expenses be provided to the faculty member? (CMDA must have documentation of payment) 24 CONTENT DEVELOPMENT 13) How does this activity support the CMDA CE Mission (see the CMDA Mission in the Course Director Manual)? 14) This CME activity is planned to meet the needs of what groups of practicing healthcare professionals (target audience)? List all groups: 15) How does the content of this activity match the learners’ current or potential scope of professional activities? 16) What are the educational format(s) for this CME activity? (check all that apply) ___Lecture ___Teleconference ___Internet ___Roundtable ___Q & A session ___Self-directed ___Case studies ___Panel discussion ___Skilled demonstration ___Stimulations ___Lab activity ___Audience Response System 17) Please UNDERLINE the activity type for this CME activity? Live Activity Enduring Material Journal-based CME activity Internet CD-ROM/DVD Podcast Other (explain)_____________________________________________________________________ 18) Briefly explain how your format and type of activity are appropriate for the setting, objectives, and the results of this educational activity. 25 19) What procedures were used to identify the existing professional practice gap(s) between current and best practices of your target audience? Please check all that apply. If a part of your process has been identification of gaps by experts and your planning committee, faculty or planners’ perception of need, or opinion leader interviews, please attach a one or two paragraph description detailing your discussions and how you intend to address gaps through the educational activity. Documentation for each procedure indicated must be attached ___Survey of targeted learners ___Review of peer reviewed literature ___Clinical practice data ___Professional Practice Gap(s) identified by target audience/expert ___National clinical guidelines (NIH, NCI, AHRQ) ___Requirements of state licensing board, specialty societies ___Required by practice administration ___Required by governmental authority/regulation/law ___Research findings/translations of research into practice ___New information (diagnostic techniques, treatment plans) ___Requests from physicians or physicians groups ___*Helps to meet CMDA CE Mission ___Public health data ___Faculty and/or planners’ perception of need (attach a statement) ___Summary of previous outcomes data ___Practice or specialty society clinical guidelines ___Committee findings/audits ___Epidemiological data ___Direct to consumer ads ___Lay press ___Societal trends ___Other (please attach description) *Please review CMDA Mission (see Course Director Manual) 20) Please provide citations of peer-reviewed articles (scientific/medical journals, etc.) that were used as one of the determining factors for identifying each of the professional practice gaps. 21) Identify the professional practice gaps(s), what has caused the gap, the desired results of the educational intervention and classify the need for this educational intervention in terms of knowledge, competence or performance (see chart below). IDENTIFY THE EDUCATIONAL PRACTICE GAP(S) (Current practice) DESCRIBE WHAT HAS CAUSED THE PROFESSIONAL PRACTICE GAP Desired results (best-practice) What are healthcare professionals not doing? Why aren’t they doing it? What will be the results of solving this problem? EXAMPLE Physicians are not using the diagnostic criteria to screen EXAMPLE Literature indicates that at least 25% of physicians have EXAMPLE Participants will be able to: -Write the diagnostic criteria Classify the educational needs in terms of knowledge, competence, performance and/or patient outcomes Changes in competence and/or performance are required. _X_Knowledge: _X_Competence _X_Performance 26 pre-school age children for Autism. not been educated on the diagnostic criteria for autism screening. for screening pre-school age children for Autism, -Create individualized treatment plans to manage pre-school age autistic patients, and -Develop procedures to screen pre-school age children who present with autistic behaviors. Patient outcomes: Using procedures to screen preschool age children earlier and the individualized treatment plan will change the outcome of the patients. _X_Patient Outcomes _ _ Knowledge Competence Performance ___Patient Outcomes _ Knowledge Competence Performance ___Patient Outcomes Knowledge Competence Performance ___Patient Outcomes _ _ Knowledge Competence Performance ___Patient Outcomes (add additional rows to this table as needed) 22) Based on the desired results you described in the gap chart above, list the learning objectives for this activity. Learning objectives help learners understand the specific result they can expect to achieve by participating in this educational activity. LIST AT LEAST ONE OBJECTIVE FOR EACH OUTCOME YOU LISTED ABOVE As a result of participating in this activity, participants will be able to: (example: Explain the diagnostic criteria used to screen autism). 1. 2. 3. (continue numbering if additional objectives are listed) 23) Is this activity designed to change competence, performance and/or patient outcomes? 24) The competencies/physician attributes were founded on the Maintenance of Certification (MOC) competencies designed by the American Board of Medical Specialties (ABMS) the competencies established by the Accreditation Council for Graduate Medical Education (ACGME), and the desirable physician attributes established by the Institutes of Medicine (IOM). Once you have decided on the competencies/physicians attributes to be used to develop this activity, (1) place an “X” in the first box of the table for each competency/physician attribute, (2) write the objective(s) number in the last column of the table that corresponds to the competency/physician attribute you selected. Example: Objectives numbers 1, 3, and 6. 27 PLACE AN “X” COMPETENCIES/PHYSICIANS ATTRIBUTES Patient Care (provide care that is compassionate, appropriate and effective treatment for health problems and to promote health). Medical Knowledge (demonstrate knowledge about established and evolving biomedical, clinical and cognate sciences and their application in patient care). Practice-based Learning and Improvement (investigate and evaluate patient care practices, appraise and assimilate scientific evidence and improve practice of medicine). Systems-based Practice (demonstrate awareness of and responsibility for larger context and systems of healthcare; call on system resources to provide optimal care, e.g., coordinating care across sites or serving as the primary case manager when care involves multiple specialties, professions, or sites). Professionalism (demonstrate a commitment to carrying out professional responsibilities, adherence to ethical principles and sensitivity to diverse patient populations). Interpersonal and Communication Skills (demonstrate skills that result in effective communication and teaming with patients, their families and professional associates, such as fostering a therapeutic relationship that is ethically sound; using effective listening skills with non-verbal and verbal communications; working as both a team member and at times as a leader). Provide patient-centered care (identify, respect, and care about patients’ differences, values, preferences and expressed needs; relieve pain and suffering; coordinate continuous care; listen to, clearly inform, communicate with, and educate patients; share decision making and management; and continuously advocate disease prevention, wellness, and promotion of healthy lifestyles, including a focus on population health). Work in Interdisciplinary Teams (cooperate, collaborate, communicate, and integrate care in teams to ensure that care is continuous and reliable). Employ Evidence-based Practice (integrate best research with clinical expertise and patient Content in this activity that reflects the competencies you selected – Cite the learning objective number(s) 1, 3, 6, etc. 28 values for optimum care; participant in learning and research activities to the extent feasible). Apply Quality Improvement (identify errors and hazards in care; understand and implement basic safety design principles; continually understand and measure quality of care in terms of structure, process and outcomes in relation to patient and community needs; design and test interventions to change processes and systems of care with the objective of improving quality). Utilize Informatics (communicate, manage knowledge, mitigate error, and support decision making using information technology). 25) Based on the Gap (educational needs) of your target audience, provide a timed agenda along with the topics and the faculty names for each topic. Application cannot be reviewed if this information is missing. (CMDA approves to the quarter hour and only the time actually spent in the educational session) EXAMPLE: TIME 8 - 9 am (1 HR Requested) 9:00 am 9:15 – 10 am (.75 HR Requested) 10:00 AM TOPIC TITLE Overview of Autism Break Topic FACULTY NAME John Doe, MD, PhD N/A Jane Doe, MD Adjourn 26) Please provide an abstract for each topic. Include the topic title and faculty name with each abstract. Application cannot be reviewed if this information is missing. EDUCATIONAL EVALUATION, BARRIERS, NON-EDUCATIONAL STRATEGIES 27) CMDA will develop an online evaluation to evaluate and analyze changes in your learners’ professional practice gaps (i.e., changes in knowledge, competence, performance and practice changes). Three to four months after the completion of the activity, CMDA will send a follow-up outcomes survey to measure changes to professional practice as well as competence, performance and/or patient outcomes from this activity. The outcomes survey is sent to all participants who submitted the initial evaluation. 28) Please identify factors outside your control that have an impact on patient outcomes (examples: insurance, patient not following recommended dosage, patient’s support system, etc.). 29) Identify anticipated barriers that the participant’s may have in trying to implement changes in their practice (examples: formulary restrictions, insufficient time for implementation of new skills or behaviors, lack of insurance reimbursement, lack of organizational support, lack of resources, policy issues within the organization, 29 unwillingness to make changes). Recommend educational strategies that you will discuss during this activity to remove, overcome, or address these barriers. ANTICIPATED BARRIER(S) TO PARTICIPANT CHANGES IN PRACTICE PLANS TO ADDRESS OR OVERCOME THE BARRIER(S) 30) Planners of this activity are encouraged to employ non-educational strategies for participants (examples: handouts, CD’s, videos, websites, etc.) to reinforce the intended results of this activity. Please list any non-educational strategies that you will use and the purpose of the strategy. Non-educational Strategy CMDA will E-mail a follow-up outcomes survey to participants of this activity. Purpose of the Strategy The outcomes survey will remind participants of the changes they will implement as well as focus on changes in professional practice. COURSE LOGISTICS CMDA neither sponsors nor joint-sponsors activities that are supported by a commercial interest, however CMDA does accept commercial exhibitors. The ACCME definition for a commercial interest: “A commercial interest is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.” 31) Will this activity have Commercial exhibits? Yes No See definition of commercial interest above. Review the ACCME Standards for Commercial SupportSM) in the Course Director’s Manual. If Yes, please provide list of participating commercial exhibitors and COMPLETE THE EXHIBIT FORM. The ACCME requires that a list of all exhibitors be distributed to your participants before the educational activity is presented. For that reason, CMDA will provide a Welcome Letter, which will include this information for your participants. NAME OF EXPECTED/INVITED COMMERCIAL EXHIBIT ORGANIZATION(S) and contact e-mail address: NAME OF ORGANIZATION E-MAIL ADDRESS Add additional rows to this table as needed 30 The ACCME definition of non-commercial exhibitor: Providers of clinical services directly to patients, such as hospitals, health systems, medical group practices, blood banks, and diagnostic laboratories, are an integral component of accredited CME and CDE because they represent the provision of CME by the profession for the profession. Therefore, these entities have been deemed NOT to be commercial interests. 32) Will this activity have non-commercial exhibits? Yes No See definition of non-commercial interest above. Review the ACCME Standards for Commercial SupportSM) in the Course Director’s Manual. If Yes, please provide list of participating non-commercial exhibitors. NON-COMMERCIAL EXHIBITORS DO NOT NEED TO COMPLETE THE EXHIBIT FORM. The ACCME requires that a list of all exhibitors be distributed to your participants before the educational activity is presented. For that reason, CMDA will provide a Welcome Letter, which will include this information for your participants. NAME OF EXPECTED/INVITED NON-COMMERCIAL EXHIBIT ORGANIZATION(S) and contact e-mail address: NAME OF ORGANIZATION E-MAIL ADDRESS Add additional rows to this table as needed *NOTE: A final list of confirmed exhibitors MUST be submitted 30 days prior to the conference so that required follow-up can be done by the CE Department. 33) If this activity will have commercial and/or non-commercial exhibitors, where will they be located with respect to the CE educational activity? _________________________________________________________________________________ 34) Is there a registration fee for participants? If yes, how much? Physicians $ Physicians Assistant Residents, $ Nurses $ Students, $ Others (please specify): $ Yes No X Signature Activity Director (electronic signature or typed name is acceptable if sending electronically) Signature 31 Date: IF THIS ACTIVITY IS CANCELED WITHIN 30 DAYS OF THE START DATE, THERE WILL BE A $500 ADDITIONAL CANCELLATION FEE PLUS COLLECTION OF ANY EXPENSES INCURRED BY CMDA. Christian Medical & Dental Associations does not share in profit or loss for this symposium. Christian Medical & Dental Associations educational activities are reviewed by the CMDA committee for scientific content, relevance to healthcare professionals, congruence with the CMDA mission, and credentials of speakers. All symposiums must be approved by the CMDA committee. By serving in this role, the Committee is serving as part of the planning process for all activities sponsored by the CMDA. CMDA FEE FOR SPONSOR/JOINT-SPONSORSHIP ACTIVITY FEE(s) *CME Application Fee for direct sponsored activity - $500.00 *CME Application Fee for jointly sponsored activity - $850.00 Total Activity Fee due UPON SUBMISSION OF APPLICATION $ $ $ *IF during the review process the application is denied by the review committee OR if the activity is cancelled at any time after submission, there will be a $200 non-refundable application review fee. DUE AFTER COMPLETION OF THE ACTIVITY Transcript Fee - $10 per credit hour approved/Per person (Example: 4 hours approved for the activity = $40 post activity fee x 22 participants claiming CE = $880.00 Post Activity Fee Due) A Financial wrap-up report along with Transcript Fee for this course is required within 30 days following activity completion. __________________________ NOTE: The CMDA CE Department desires to keep its fees reasonable in comparison to the national average. For large organizations or large events, the CMDA CE Department is willing to base its fees on the number in attendance and/or whether it is a sponsored or joint-sponsored CE activity. Please contact Barbara Snapp (1-888-230-2637 or barbara@cmda.org) to discuss additional options if needed before submitting this application. FEE FOR ADDITIONAL SERVICES (non-negotiable) $300 AAFP Credits $300 Dental (Academy of General Dentistry - IF submitted separately from the medical application) $300 Nursing (in order for CMDA to apply for nursing credit, you must submit speaker Bio sketches, speaker & planner disclosures and overview of each speaker presentation with this application) 32 $300 Nurse Practitioner (in order for CMDA to apply for nurse practitioner credit, you must submit speaker Bio sketches, speaker & planner disclosures and overview of each speaker presentation with this application) $300 Physician Assistant Course/Activity logistics that must be provided to the CMDA/CE office: Application for Credits (must be approved by the CMDA Committee). Draft brochure for review and approval. 5 original brochures. Sign-in sheets/attendance verification document (typed and electronic). Copies of faculty/course director reimbursement checks for travel and lodging etc. Copies of faculty/course director honoraria checks List of exhibitors (If applicable) Budget reconciliation - accounting of income and expenses. BEFORE YOU SUBMIT THIS APPLICATION MAKE SURE: APPLICATION IS SIBMITTED ELECTRONICALLY IN A WORD DOCUMENT ALL QUESTIONS ON THE APPLICATION ARE ANSWERED PROPOSED BUDGET 33 PROMOTIONAL CONTENTS FOR A CMDA CE ACTIVITY (For planning purposes) Following is a list of what is needed on the brochure/flyer: A COPY OF THE PROMOTIONAL PIECE IS REQUIRED TO BE APPROVED BY THE ACCREDITATION OFFICER OR CE DIRECTOR PRIOR TO PRINTING: Brochure Content -Course title -Agenda (course content) -Teaching method to be used -Target audience -Educational objectives -Special needs statement (see below) -NO COMMERCIAL SUPPORT FOR THIS ACTIVITY at the bottom of the brochure/flyer. -Faculty names and credentials -Costs and Refund policy (if applicable) -Course location, date, time etc. -Contact information (for registration and follow-up questions) -CMDA logo must be used (Program provider) -Accreditation with ACCME logo and designation statements (see below) PLEASE NOTE: Each of the statements below must be worded exactly as they appear. If you need clarification, call the CE Department. Special Needs If you need special accommodations due to a disability or for an alternative form of course materials, please contact us at YOUR ORGANIZATION’S TELEPHONE NUMBER at least 14 days prior to the program. CMDA’s Department of Continuing Education fully complies with the legal requirements of the ADA and the rules and regulations thereof. CONTINUING MEDICAL EDUCATION Sponsorship Statement Accreditation Statement (sponsorship) The Christian Medical & Dental Associations is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. CONTINUING MEDICAL EDUCATION Joint Sponsorship Statement Accreditation Statement (joint sponsorship) This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the Christian Medical & Dental Associations (CMDA) and the <Name of non-accredited provider>. Christian Medical & Dental Associations is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA Designation Statement (direct sponsorship) The Christian Medical & Dental Associations designates this educational activity for a maximum of <credits approved> AMA PRA Category 1 Credits(s) ™. Physicians should only claim credit commensurate with the extent of their participation in the activity. NOTE: Please be sure to italicize AMA PRA Category 1 Credit(s) TM and use the superscript TM CAPITALIZED. 34 DENTAL CONTINUING EDUCATION (If applicable to your event. A separate application and additional processes are also required.) (IF Joint Sponsored) This activity has been planned and implemented in accordance with the standards of the Academy of General Dentistry (AGD) Program Approval for Continuing Education (PACE) through the joint program provider approval of Christian Medical & Dental Association and <Name of non-approved program provider>. AND. . . . The Christian Medical & Dental Associations is designated as an Approved PACE Program Provider by the Academy of General Dentistry. The formal continuing dental education programs of this program provider are accepted by AGD for Fellowship/Mastership and membership maintenance credit. Approval does not imply acceptance by a state or provincial board of dentistry or AGD endorsement. The current term of approval extends from 1/1/2011 to 12/31/2014. Provider ID# 218742 Also, the Academy of General Dentistry PACE logo must appear somewhere in the brochure preferably near the AGD statement (no more than 2 inches in height). The AGD requires a Course Completion Code on the attendance verification form for dental credit. THE FOLLOWING STATEMENTS ARE APPLICABLE ONLY IF YOU ARE REQUESTING THESE CONTINUING EDUCATION CREDITS FOR YOUR ACTIVITY (See application to request credit and for fees associated with this service) AAFP Credit Application for AAFP credit has been filed with the American Academy of Family Physicians. Determination of credit is pending. (be sure to highlight the last sentence) Physician Assistant AAPA accepts certificates of participation for educational activities certified for AMA PRA Category 1 CreditTM by an organization accredited by the ACCME or a recognized state medical society. Physician assistants may receive ___ hours of Category 1 credit for completing this program. Nurse Practitioner Verbiage will be provided upon approval. Nursing Verbiage will be provided upon approval. ALL PROMOTIONAL MATERIALS MUST BE APPROVED BY THE CMDA/CE DEPT PRIOR TO BEING RELEASED. 35 CMDA - DISCLOSURE - CONFLICT OF INTEREST RESOLUTION - CONTENT VALIDATION (CMDA) - RESOLUTION PERSONAL CONFLICTS OF INTEREST Christian Medical & Dental Associations has implemented a process where everyone (including immediate family members) who is in a position to control the content of an educational activity has disclosed to us all relevant financial relationships with any commercial interest. In addition, should it be determined that a conflict of interest exists as a result of a financial relationship that you may have, it will need to be resolved before we can move to the next step in planning this CE activity. An individual who refuses to disclose relevant financial relationships will be disqualified from being a planner, teacher, or an author of CE and cannot have control or responsibility for the development, management, presentation or evaluation of a CMDA CE activity. If you have a conflict of interest and it is not resolved, your presentation cannot be awarded CE credit. Glossary of Terms Commercial Interest A commercial interest is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on patients. (The only exception is those received from non-profit or government organizations) Financial Relationships Financial relationships are those relationships in which the individual benefits by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit. Financial benefits are usually associated with roles such as employment, management position, independent contractor (including contracted research), consulting, speaking and teaching, membership on advisory committees or review panels, board membership, and other activities from which remuneration is received, or expected. ACCME and AGD consider relationships of the person involved in the CE activity to include financial relationships of a spouse or partner. Relevant financial relationships CMDA focuses on financial relationships with commercial interests in the 12-month period proceeding the time that the individual is being asked to assume a role controlling content of the CE activity. The ACCME or AGD has not set a minimal dollar amount for relationships to be significant. Inherent in any amount is the incentive to maintain or increase the value of the relationship. To aid in this review, the ACCME defines “’relevant’ financial relationships” as financial relationships in any amount occurring within the past 12 months that create a conflict of interest. Conflict of Interest Circumstances create a conflict of interest when an individual has an opportunity to affect CE content about products or services of a commercial interest with which he/she has a financial relationship. First, list the names of proprietary entities producing health care goods or services, with the exemption of non-profit or government organizations and non-health related companies with which you or your spouse/partner have, or have had, a relevant financial relationship within the past 12 months. For this purpose, we consider the relevant financial relationships of your spouse or partner that you are aware to be yours. Second, describe what you or your spouse/partner received (ex: salary, honorarium etc.). Christian Medical & Dental Associations does NOT want to know how much you received. Third, describe your role. Commercial Interest (company) What I Received (salary, honorarium, My Role (speaker, employment, contract) stocks) ___Neither I nor an immediate family member has a personal financial relationship(s) relevant to the content of this CE activity. ___The relationships identified above are not associated with the content of my presentation and will not be discussed or presented on any material. Are your recommendations involving clinical medicine/oral healthcare based on evidence that is accepted within the profession of medicine/dentistry as adequate justification for their indications and contraindications in the care of patients? ___YES ___NO ___N/A In your presentation, does all scientific research, reported or used in support or justification of a patient care recommendation conform to the generally accepted standards of experimental design, data collection, and analysis? ___YES ___NO ___N/A I will use only generic names when discussing therapeutic options. ___YES ___NO ___N/A If no, you must refer to trade names of several companies. I intend to discuss unlabeled/investigational use(s) of a drug(s) or device(s) in my presentation. ___YES ___NO ___N/A The materials used in my presentation(s) have not been falsified and will not misrepresent the outcome of treatment. __I agree__ N/A (AGD Requirement) Print Your Name Signature Date_______________ 36 CMDA Conflict of Interest Resolution Disclosure Provided? NO: Person cannot participate in coordinating, planning, authoring, speaking, moderating; and cannot have control of or responsibility for the development, management, presentation or evaluation of the CME activity. The disclosure form is evaluated by CE Director & Accreditation Officer. If no disclosures are Listed, evaluation ends. However, if there are disclosures listed, evaluation continues. Yes If financial relationships are disclosed by coordinators, planners, authors, speakers, moderators or immediate family members and the individual has indicated on the disclosure form that the relationships are not associated with the content of their presentation, the Accreditation Officer will review the disclosures and determine whether the evaluation ends. However, the evaluation will continue... If coordinators, planners, authors/speakers, moderators or members of their immediate families have relevant financial relationships that create a conflict of interest. The following steps will apply: Coordinators, CE Director, Accreditation Officer recues themselves from planning an activity. Course directors & planning committee members recues themselves from planning an activity. CE committee members recues themselves from reviewing an activity application and speaker presentations. Course directors, planning committee members or CE committee members will review speaker presentations and may require changes. If the speaker does not comply with edits by reviewers, s/he will be disqualified from presenting. Moderators & panel members will be replaced with someone who does not have a COI. 37 COMMERCIAL EXHIBITOR FORM ONLY COMMERCIAL EXHBITORS NEED TO COMPLETE THIS FORM IF YOU ARE A COMMERCIAL INTEREST (*see definition below), please read and complete this document, which reflects agreement and adherence to the ACCME Standards for Commercial Support, CMDA policies, and AGD. Return to the coordinator of this CE activity. Commercial Exhibitors ACCME states: Commercial exhibits and advertisements are promotional activities and not continuing medical education. Therefore, monies paid by commercial interests for these promotional activities are not considered to be commercial support. CMDA fulfills the requirements of the ACCME Standards for Commercial Support (SCS 4) and AGD Standard XII in using sound fiscal and business practices with respect to promotional activities. Definition of Commercial Support Commercial Support for a CE activity is financial or in-kind contributions given by a commercial interest, which is used to pay all or part of the costs of a CE activity. Definition of Commercial Interest Commercial interest (supporter) is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. Non-commercial Interest Providers of clinical services directly to patients, such as hospitals, health systems, medical group practices, blood banks, and diagnostic laboratories, are an integral component of accredited CME and CDE because they represent the provision of CE by the profession for the profession. Therefore, these entities have been deemed NOT to be commercial interests. Commercial Interest Limitations -Commercial interests are not eligible for ACCME accreditation or AGD PACE Approval. Commercial interests cannot be accredited or PACE approved providers and cannot be joint sponsors. -Arrangements for commercial exhibits or advertisements cannot influence planning or interfere with the presentation, nor can they be a condition of the provision of commercial support for CE activities (CMDA does not accept commercial support for CE activities). -Product-promotion material or product-specific advertisement of any type is prohibited in or during CE activities. The coincidence of editorial and advertising material on the same products or subjects must be avoided. Live (staffed exhibits, presentations) or enduring (printed or electronic advertisements) promotional activities must be kept separate from CME. There will be no ‘commercial breaks.’ For live, face-to-face CE, advertisements and promotional materials cannot be displayed or distributed in the educational space immediately before, during, or after a CE activity. CMDA will not allow representatives of Commercial Interests to engage in sales or promotional activities while in the space or place of the CE activity. -Print advertisements and promotional materials will not be interleafed within the pages of the CE content. Advertisements and promotional materials may face the first or last pages of printed CE content as long as these materials are not related to 38 the CE content they face and are not paid for by the commercial supporters of the CE activity (CMDA does not accept commercial support for CE activities). -Computer based advertisements and promotional materials will not be visible on the screen at the same time as the CE content and not interleafed between computer ‘windows’ or screens of the CE content. Audio and video recording advertisements and promotional materials will not be included within the CE. -Print or electronic information distributed about the non-CE elements of a CE activity that are not directly related to the transfer of education to the learner, such as schedules and content descriptions, may include product-promotion material or product-specific advertisement. -CMDA will not use a commercial interest as the agent providing a CE activity to learners, e.g., distribution of self-study CE activities or arranging for electronic access to CE activities. -CMDA will ensure that their learners can participate in educational activities without seeing, reading or hearing promotional or marketing information from commercial interests. In addition, CMDA will ensure that the selling of advertising or exhibit space is a business transaction entirely separate from the acceptance of commercial support for accredited CME or CDE by refusing to accept commercial support for CMDA educational activities. -CMDA follows the policies of the ACCME and the AGD by insisting on the separation of education from all promotional activities, materials and messages. CMDA may create a print or text based document that goes along with an activity and provides information that is supplementary to the educational content - like reproductions of slides, graphics, thumb drives or other handouts. These documents, in print or electronic, are an integral part of the education and as such will not have any advertising, trade name or a product-group message associated with them. -If a commercial interest seeks to purchase advertising and promotional opportunities with resources designated for that purpose and an agreement for advertising and promotion between CMDA and the commercial interest is established, CMDA will not accept commercial support and no written agreement for commercial support will be considered. Any event or product that contains advertising or promotional opportunities will not be part of the educational CE activity and must not be paid for by commercial support and the advertisement and/or promotional opportunity will be assigned to the "exhibit hall." Advertising pages or screens or promotional receptions or meals will be clearly identified as such to the learner by CMDA. -Promotional events at CMDA CE activities (e.g., exhibit halls) are kept distinct and separate from CE activities by not only their location and time in the program schedule, but also in how these events are clearly described as "Promotional" to CMDA learners. I attest that I have read this document and agree to abide by its policies and guidelines. Name of the commercial exhibit organization: *Name of the Representative(s) from the commercial exhibitor organization: Email address of the Representative of the commercial exhibitor organization Title of this CE activity Date of this activity Amount of Money Paid to Exhibit at this CE activity $ *Typed name will serve as the signature I understand that if I reserve exhibit space and do not show to claim such space, the exhibit fee is not waived and is due and payable to the host organization named above. 39 ACCME STANDARDS FOR COMMERCIAL SUPPORT Standards to Ensure the Independence of CME Activities Definition: The Provider is the institution providing the CME credit. The Educational Partner is the joint sponsor (not the commercial supporter). The ACCME Standards for Commercial SupportSM Standards to Ensure Independence in CME Activities STANDARD 1: Independence 1.1 A CME provider must ensure that the following decisions were made free of the control of a commercial interest. (See www.accme.org for a definition of a ‘commercial interest’ and some exemptions.) (a) Identification of CME needs; (b) Determination of educational objectives; (c) Selection and presentation of content; (d) Selection of all persons and organizations that will be in a position to control the content of the CME; (e) Selection of educational methods; (f) Evaluation of the activity. 1.2 A commercial interest cannot take the role of non-accredited partner in a joint sponsorship relationship. STANDARD 2: Resolution of Personal Conflicts of Interest 2.1 The provider must be able to show that everyone who is in a position to control the content of an education activity has disclosed all relevant financial relationships with any commercial interest to the provider. The ACCME defines “’relevant’ financial relationships” as financial relationships in any amount occurring within the past 12 months that create a conflict of interest. 2.2 An individual who refuses to disclose relevant financial relationships will be disqualified from being a planning committee member, a teacher, or an author of CME, and cannot have control of, or responsibility for, the development, management, presentation or evaluation of the CME activity. 2.3 The provider must have implemented a mechanism to identify and resolve all conflicts of interest prior to the education activity being delivered to learners. STANDARD 3: Appropriate Use of Commercial Support 3.1 The provider must make all decisions regarding the disposition and disbursement of commercial support. 3.2 A provider cannot be required by a commercial interest to accept advice or services concerning teachers, authors, or participants or other education matters, including content, from a commercial interest as conditions of contributing funds or services. 3.3 All commercial support associated with a CME activity must be given with the full knowledge and approval of the provider. Written agreement documenting terms of support. 3.4 The terms, conditions, and purposes of the commercial support must be documented in a written agreement between the commercial supporter that includes the provider and its educational partner(s). The agreement must include the provider, even if the support is given directly to the provider’s educational partner or a joint sponsor. 40 3.5 The written agreement must specify the commercial interest that is the source of commercial support. 3.6 Both the commercial supporter and the provider must sign the written agreement between the commercial supporter and the provider. Expenditures for an individual providing CME 3.7 The provider must have written policies and procedures governing honoraria and reimbursement of out-of-pocket expenses for planners, teachers and authors. 3.8 The provider, the joint sponsor, or designated educational partner must pay directly any teacher or author honoraria or reimbursement of out-of–pocket expenses in compliance with the provider’s written policies and procedures. 3.9 No other payment shall be given to the director of the activity, planning committee members, teachers or authors, joint sponsor, or any others involved with the supported activity. 3.10 If teachers or authors are listed on the agenda as facilitating or conducting a presentation or session, but participate in the remainder of an educational event as a learner, Their expenses can be reimbursed and honoraria can be paid for their teacher or author role only. Expenditures for learners 3.11 Social events or meals at CME activities cannot compete with or take precedence over the educational events. 3.12 The provider may not use commercial support to pay for travel, lodging, honoraria, or personal expenses for non-teacher or non-author participants of a CME activity. The provider may use commercial support to pay for travel, lodging, honoraria, or personal expenses for bona fide employees and volunteers of the provider, joint sponsor or educational partner. Accountability 3.13 The provider must be able to produce accurate documentation detailing the receipt and expenditure of the commercial support. STANDARD 4. Appropriate Management of Associated Commercial Promotion 4.1 Arrangements for commercial exhibits or advertisements cannot influence planning or interfere with the presentation, nor can they be a condition of the provision of commercial support for CME activities. 4.2 Product-promotion material or product-specific advertisement of any type is prohibited in or during CME activities. The juxtaposition of editorial and advertising material on the same products or subjects must be avoided. Live (staffed exhibits, presentations) or enduring (printed or electronic advertisements) promotional activities must be kept separate from CME. • For print, advertisements and promotional materials will not be interleafed within the pages of the CME content. Advertisements and promotional materials may face the first or last pages of printed CME content as long as these materials are not related to the CME content they face and are not paid for by the commercial supporters of the CME activity. • For computer based, advertisements and promotional materials will not be visible on the screen at the same time as the CME content and not interleafed between computer ‘windows’ or screens of the CME content. • For audio and video recording, advertisements and promotional materials will not be included within the CME. There will be no ‘commercial breaks.’ • For live, face-to-face CME, advertisements and promotional materials cannot be displayed or distributed in the educational space immediately before, during, or after a CME activity. Provider cannot allow representatives of Commercial Interests to engage in sales or promotional activities while in the space or place of the CME activity. 41 4.3 Educational materials that are part of a CME activity, such as slides, abstracts and handouts, cannot contain any advertising, trade name or a product-group message. 4.4 Print or electronic information distributed about the non-CME elements of a CME activity that are not directly related to the transfer of education to the learner, such as schedules and content descriptions, may include product promotion material or product-specific advertisement. 4.5 A provider cannot use a commercial interest as the agent providing a CME activity to learners, e.g., distribution of self-study CME activities or arranging for electronic access to CME activities. STANDARD 5. Content and Format without Commercial Bias 5.1 The content or format of a CME activity or its related materials must promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest. 5.2 Presentations must give a balanced view of therapeutic options. Use of generic names will contribute to this impartiality. If the CME educational material or content includes trade names, where available trade names from several companies should be used, not just trade names from a single company. STANDARD 6.Disclosures Relevant to Potential Commercial Bias Relevant financial relationships of those with control over CME content 6.1 An individual must disclose to learners any relevant financial relationship(s), to include the following information: • The name of the individual; • The name of the commercial interest(s); • The nature of the relationship the person has with each commercial interest. 6.2 For an individual with no relevant financial relationship(s) the learners must be informed that no relevant financial relationship(s) exist. Commercial support for the CME activity. 6.3 The source of all support from commercial interests must be disclosed to learners. When commercial support is ‘in-kind’ the nature of the support must be disclosed to learners. 6.4 ‘Disclosure’ must never include the use of a trade name or a product-group message. Timing of disclosure 6.5 A provider must disclose the above information to learners prior to the beginning of the educational activity. 42 AGD PACE Standard XII Commercial or Promotional Conflict of Interest 43 (Continued: AGD PACE Standard XII Commercial or Promotional Conflict of Interest)