Vanderbilt University School of Medicine DIVISION OF CONTINUING MEDICAL EDUCATION Application Submission Checklist Persons requesting CME credit from the Vanderbilt Division of CME must follow these procedures: Step 1. Register in the VCME Learning Management System CME Associate sets up User Profile Step 2. Submit application materials prior to activity start date Departmentally managed activities: all materials should be submitted at least six months in advance of the activity start date. Credit will not be awarded if applications are submitted less than three months prior to the activity start date. Jointly sponsored activities: all materials must be submitted at least six months in advance of the activity start date. Regularly scheduled series (RSS): all materials should be submitted at least three months in advance of the activity start date. Credit will not be awarded if applications are submitted less than one month prior to the activity start date. All activities: Application form including signed cover sheet Documentation for performance gap Completed/signed Disclosure of Financial Relationships form for each Course Director and (content) Planner Preliminary schedule or agenda Preliminary budget Evaluation form Recurring departmentally managed and jointly sponsored activities only: Close-out of previous activity Jointly sponsored activities only: Partnership agreement Step 3. Review CME and ACCME guidelines Read Overview of VCME Policies and Procedures Course Director and Vanderbilt CME Director meet to discuss content of application CME Associate participates in VCME training Vanderbilt CME, Application for Sponsorship and Credit Designation of a CME Activity, page 2 Vanderbilt University School of Medicine DIVISION OF CONTINUING MEDICAL EDUCATION Application for Sponsorship and Credit Designation of a CME Activity Title of CME Activity Sponsoring Department Date, Day, Time Location Course Director CME Associate VU SOM Academic Rank Title Telephone Telephone Fax Fax Email Email VCME Asst. Director Nanette Bahlinger VCME Administrator Telephone 615-322-0672 Telephone Fax 615-322-4526 Fax Email nanette.bahlinger@vanderbilt.edu To be completed by VCME Email Submission 1. The information on this form is the result of educational and administrative planning associated with offering this CME activity. 2. I have reviewed the “Disclosure of Financial relationships” form for the planners of this CME activity and determined that there are no conflicts of interest between the financial relationship(s) that were disclosed and the content of this CME activity. 3. I understand that it is my responsibility to review the presentations of speakers who indicate that they have financial relationships with companies that make products or services related to the content of their presentations. Course Director Date Approval 1. I approve the sponsorship of this CME activity by my department or division. 2. I accept financial responsibility on behalf of my department/division for the direct and indirect expenses of this CME activity 3. I have reviewed the “Disclosure of Financial Relationships” form for the course director and determined that there are no conflicts of interest between the financial relationship(s) that were disclosed and the content of this CME activity. Chair/Chief Approved for Date _____ AMA PRA Category 1 Credits Director, Division of CME: _________________________________________ Fee: ________ Date: ________ CME Application 2011 Vanderbilt CME, Application for Sponsorship and Credit Designation of a CME Activity, page 3 1. List below individuals who are involved in planning the content of this CME activity. Name Institution Role Course Director Planner Planner Planner Planner Each individual listed above may be able to influence the content of this CME activity. ACCME requires that each of these individual disclose financial relationships related to the content of this CME activity. To meet this requirement, each individual must complete the Vanderbilt CME form, “Disclosure of Financial Relationships.” 2. 1. The completed forms for each individuals listed above must accompany this application. 2. The “Disclosure of Financial Relationships” forms for each individual listed above must be reviewed, approved, and signed by the course director prior to the submission of this request. 3. The “Disclosure of Financial Relationships” form for the course director must be reviewed, approved, and signed by the division chief or department chair prior to the submission of this request. What type of educational activity are you planning? (Select one) Performance improvement Internet searching and learning Live course Enduring material, internet: archived webcast Live regularly scheduled series Enduring material, other: print, CD, DVD Live internet: video conference, webcast Manuscript review Test item writing Journal CME 3. Describe the target audience for this CME activity. Include information about physician specialties, other health professions, and geographic area. 4. What type of results do you hope to accomplish by offering the CME activity you are planning? (Select only one.) Competence Physicians should be able to describe a new or improved strategy that applies to the content in clinical practice or demonstrates application of the content in a simulated practice environment or educational setting. Go to item #5. Performance Physicians actually apply the content of this CME activity in their practice settings. Skip item #5; go to item #6 CME Application 2011 Vanderbilt CME, Application for Sponsorship and Credit Designation of a CME Activity, page 4 5. Describe how you will plan and evaluate this educational activity to achieve the desired results of improved COMPETENCE by responding to the items below. This question consists of six parts (a-f), each of which must be answered. Competence means that physicians should be able to 1) describe a new or improved strategy that applies the content in clinical practice 2) demonstrate application of the content in a simulated practice environment or educational setting a. Please describe the current competence(ies) that you want to improve and/or the new competence(ies) that you want to develop by offering this CME activity. b. Please state the educational need that must be addressed before the current competence(ies) can be improved or new competence(ies) can be addressed. Your educational need statement should describe a gap between the current level of knowledge, skills, and attitudes, and the level of knowledge, skills, and attitudes necessary for competence(ies) to be improved or new competence(ies) to be developed. c. Where did you obtain information about current and desired levels? Desired Levels Current Levels Questionnaire before CME activity Summary of results Case scenario(s) before CME activity Summary of results Peer-reviewed journal article Abstract(s) attached Expert opinion Written summary from the expert(s) Interview/focus group Summary Request by target audience Summary Quality improvement data Summary Practice guideline/clinical pathway Table of contents or executive summary Other, _____________________________ Method: d. Example of expected documentation: Based on the results that you want to accomplish, state three or more things that you would like physician participants to be able to do after they participate in this CME activity. (Learning objectives) After participating in this CME activity, participants should be able to describe and discuss: 1) 2) 3) CME Application 2011 Vanderbilt CME, Application for Sponsorship and Credit Designation of a CME Activity, page 5 e. To accomplish your goal of improving current competence(ies) or developing new competence(ies), the educational activity that you are planning should include the following educational strategies. Please indicate if you will be using these strategies and the specific technique that you will be using. f. Physician participants are provided with opportunities to hear information related to the competence(ies) to be improved and/or developed. Lectures Panel presentations Readings distributed before the CME activity Other: Physician participants are provided with opportunities to hear and/or see examples of the improved and/or new competence(ies) in practice settings. Case presentations Skill/technique demonstration Other: During the CME activity, physician participants are provided an opportunity to practice the competence(ies) that they learned. Case discussion Case discussion with audience response system (ARS) Skills lab Animal lab Other: During the CME activity, physician participants are provided feedback on the competence(ies) that they demonstrated. ARS results and discussion One on one discussion Group discussion Other: How do you intend to determine whether or not physician participants have improved current competence(ies) or developed new competence(ies)? (Evaluation) self-report questionnaire after the CME activity (CME will provide a template.) self-report questionnaire before and after the CME activity commitment to change after the CME activity commitment to change after the CME activity and follow-up self-report questionnaire using case scenarios after the CME activity self-report questionnaire using case scenarios before and after the CME activity observation by faculty during the CME activity other, please specify: A proposed evaluation form that assesses physician competence must accompany this application. SKIP TO ITEM #7 CME Application 2011 Vanderbilt CME, Application for Sponsorship and Credit Designation of a CME Activity, page 6 6. Describe how you will plan and evaluate this educational activity to achieve the desired results of improved PERFORMANCE by responding to the items below. This question consists of six parts (a-f), each of which must be answered. Performance means that physicians actually apply the content of this CME activity in their practice settings a. Please describe the performance in practice that you would expect to see as a result of offering this CME activity. b. Please state the educational need that must be addressed before the expected performance in practice can be demonstrated. Your educational need statement should describe a gap between the current level of knowledge, skills, and attitudes as well as competence, and the level of knowledge, skills, and attitudes as well as competence necessary for the expected performance in practice to result. c. Where did you obtain information about current and desired levels? Desired Levels Current Levels Questionnaire before CME activity Summary of results Case scenario(s) before CME activity Summary of results Peer-reviewed journal article Abstract(s) attached Expert opinion Written summary from the expert(s) Interview/focus group Summary Request by target audience Summary Quality improvement data Summary Practice guideline/clinical pathway Table of contents or executive summary Other, _____________________________ Method: d. Example of expected documentation: Based on the results that you want to accomplish, state three or more things that you would like physician participants to be able to do after they participate in this CME activity. (Learning objectives) After participating in this CME activity, participants should be able to: 1) 2) 3) CME Application 2011 Vanderbilt CME, Application for Sponsorship and Credit Designation of a CME Activity, page 7 e. To accomplish your goal of improving current competence(ies) or developing new competence(ies), the educational activity that you are planning should include the following educational strategies. Please indicate if you will be using these strategies and the specific technique that you will be using. f. Physician participants are provided with opportunities to hear information related to the competence(ies) to be improved and/or developed. Lectures Panel presentations Readings distributed before the CME activity Other: Physician participants are provided with opportunities to hear and/or see examples of the improved and/or new competence(ies) in practice settings. Case presentations Skill/technique demonstration Other: During the CME activity, physician participants are provided an opportunity to practice the competence(ies) that they learned. Case discussion with ARS Skills lab Animal lab Simulation Other: During the CME activity, physician participants are provided feedback on the competence(ies) that they demonstrated. ARS results and discussion One on one discussion Group discussion Other: How do you intend to determine whether or not physician participants have improved current competence(ies) or developed new competence(ies)? (Evaluation) self-report questionnaire after the CME activity (CME will provide a template.) self-report questionnaire before and after the CME activity commitment to change after the CME activity commitment to change after the CME activity and follow-up self-report questionnaire using case scenarios after the CME activity self-report questionnaire using case scenarios before and after the CME activity observation by faculty during the CME activity other, please specify: A proposed evaluation form that assesses physician performance must accompany this application. CME Application 2011 Vanderbilt CME, Application for Sponsorship and Credit Designation of a CME Activity, page 8 7. Identify the desirable physician attributes (ABMS/ACGME Core Competencies) that will be addressed by this CME activity. 8. Patient Care that is compassionate, appropriate, and effective for the treatment of health problems and the promotion of health Medical Knowledge about established and evolving biomedical, clinical, and cognate (e.g. epidemiological and social-behavioral) sciences and the application of this knowledge to patient care Practice-Based Learning and Improvement that involves investigation and evaluation of their own patient care, appraisal and assimilation of scientific evidence, and improvements in patient care Interpersonal and Communication Skills that result in effective information exchange and teaming with patients, their families, and other health professionals Professionalism, as manifested through a commitment to carrying out professional responsibilities, adherence to ethical principles, and sensitivity to a diverse patient population Systems-Based Practice, as manifested by actions that demonstrate an awareness of and responsiveness to the larger context and system of health care and the ability to effectively call on system resources to provide care that is of optimal value Identify the speaker(s), panelists , moderators, etc, and tell us their institutional affiliation and academic title. Name Institution Academic Title Anyone in a position to influence the educational content of your CME activity is required by the ACCME to complete and sign a “Disclosure of Financial Relationships” form. This includes, but is not limited to course directors, content planners, speakers, panelists, moderators, discussants, authors, and editors. “Disclosure of Financial Relationships” forms must be submitted to the Division of CME for review at least four weeks before the CME activity begins. CME Application 2011 Vanderbilt CME, Application for Sponsorship and Credit Designation of a CME Activity, page 9 9. Please provide financial information in the budget format below: No direct costs associated with this CME activity; no budget is prepared REVENUE BUDGETED ACTUAL BUDGETED ACTUAL BUDGETED ACTUAL TOTAL EXPENSES (DIRECT + INDIRECT) BUDGETED ACTUAL DIFFERENCE (TOTAL REVENUE – TOTAL EXPENSES) BUDGETED ACTUAL Registration Fees Refunds Commercial Support (Educational Grants) With your final (actual) budget, attach a separate sheet with grants itemized; list company names and amounts. Exhibit Fees Other Revenue, Please specify source: TOTAL REVENUE DIRECT EXPENSES Speaker Expenses Speaker Fees (detailed listing required on following page) Staff Expenses Recruitment Expenses (brochure, etc.) Food and Beverage Service Facilities Course Materials Audio-visual Other Expenses, Specify: TOTAL DIRECT EXPENSES INDIRECT EXPENSES CME Fee IDS Tax Other Indirect Costs, Specify: TOTAL INDIRECT EXPENSES Please note: 1. Financial information for this CME activity in this budget format must accompany this request for credit. 2. The budget must be approved by the Division of CME before this request for credit can be approved. 3. A financial summary using the same format must be submitted after the CME activity. CME Application 2011 Vanderbilt CME, Application for Sponsorship and Credit Designation of a CME Activity, page 10 9. (continued) Please list all speakers, panelists, or moderators who will be receiving a speaker’s fee (honorarium) and the amount of the fee, and all speakers whose expenses related to their participation in this CME activity will be reimbursed. Vanderbilt CME policy on speaker fees limits what speakers can be paid. See the table of the bottom of this page. If you wish to request an exception from the policy, please place “” in the column labeled “Request Exception” and insert the number that reflects your reason from the list at the bottom of the page in the far column to the right. Speaker Expenses Amount Speaker Fee Amount (See Below.) Request Exception No Yes Reason for Request Select from list at bottom of page. Vanderbilt CME Speaker Fee policy 1. 2. Policy recommended range for speaker fee: $500 to $2,500. Policy recommendation that Vanderbilt faculty not receive speaker fee. Reasons to request an exception to Speaker Fee policy: 1. 2. 3. One of the very few people who can address this topic. Speaker is involved in multiple presentations, panels, workshops in this CME activity. Significant time away from Vanderbilt practice 4. Other, _______________________________________________ CME Application 2011 Vanderbilt CME, Application for Sponsorship and Credit Designation of a CME Activity, page 11 10. Will this CME activity receive commercial support (educational grants)? No Yes Please provide the information requested below. Use a separate sheet if more than five companies. NOTE: Effective July 1, 2009, “The Division of Continuing Medical Education should be informed at the time of submission of requests for grants to support educational events. Agreements governing grants supporting educational events must receive prior approval by the Division of Continuing Medical Education.” NOTE: Effective July 1, 2009, grants for CME-certified activities must be made payable to and processed by the Vanderbilt Division of CME. Company Amount Requested A fully executed Letter of Agreement (LOA) for each grant received must be submitted to the Division of Continuing Medical Education before the CME activity begins. At a minimum, the following terms will be agreed to: 1. The accredited sponsor is ultimately responsible for control of content and selection of presenters, moderators, etc. 2. The accredited sponsor will disclose funding sources and faculty financial relationships to the audience 3. The accredited sponsor will ensure that the CME activity provides a balanced view of therapeutic options and does not promote or unfavorably present the product or service of a pharmaceutical or medical device company 4. The accredited sponsor will require that presenters or moderators in the CME offering disclose when a product is not approved in the United States for the use under discussion. 5. The accredited sponsor will require accurate documentation detailing the receipt and expenditure of commercial support 11. Will there be exhibitors at this CME activity? No Yes Please provide the information requested below. Use a separate sheet if more than five companies. NOTE: Effective July 1, 2009, “Promotional items which incorporate or display a product or company logo of a Health Care Industry entity must not be used or displayed on the VUMC campus. This prohibition shall include exhibitions by industry representative at, or adjacent to, certified CME activities.” NOTE: Effective July 1, 2009, marketing/sales representatives will be prohibited from attending educational events sponsored by Vanderbilt. Company Amount Requested A copy of the Vanderbilt CME form “Agreement to Exhibit” for each exhibit participating, signed by a company representative must be submitted to the Division of Continuing Medical Education before the CME activity begins. 12. How will disclosures be made to the audience? (Select all that apply) Speaker & Planner Financial Relationships Commercial Support/No Commercial Support N/A In materials distributed to participants as part of the course syllabus/handout At the beginning of each speaker’s slide presentation On the sign-in sheet (RSS only) At the beginning of this enduring material, internet CME, or journal CME Documentation that the selected disclosure(s) occurred must be provided with close-out materials. CME Application 2011 Vanderbilt CME, Application for Sponsorship and Credit Designation of a CME Activity, page 12 13. Is there a registration fee for this CME activity? no yes Amount for MDs: Amount for other health professionals: Amount for non VUMC residents: Amount for non VU SOM medical students: 14. Do you plan to reduce or waive registration fees? Not applicable; no registration fee no yes VU SOM medical students No fee Fee equal to variable costs Department residents No fee Fee equal to variable costs Department physicians No fee Fee equal to variable costs Department staff No fee Fee equal to variable costs Fraud and abuse regulations restrict the individuals or groups to whom reduced or waived registration fees can be offered. Reducing or waiving registration fees can be perceived as an attempt to influence referrals to Vanderbilt physicians. 15. How will participants be recruited to register for this CME activity? Check all that apply. NOTE: Communication about CME activities sponsored by Vanderbilt School of Medicine must come from the institution or joint sponsor; representatives of pharmaceutical companies and medical device manufacturers, for example, are not allowed to recruit for CME activities. Direct mail “Mark Your Calendar”/”Save-the Date” announcement to target audience Direct mail brochure or flyer to target audience Email “Mark Your Calendar”/”Save-the Date” announcement to target audience Email brochure or flyer to target audience Announcement about your CME activity on the Department/Division web page “Mark Your Calendar”/”Save-the Date” announcement on a partner’s web page Announcement about your CME activity on a partner’s web page Letter from course director to select group of target audience Purchased journal advertising Purchased web advertising Other There are requirements for any recruitment materials that mention AMA PRA category 1 credit. This material must be reviewed and approved by the Division of CME before it can be distributed to potential participants. 16. Are you applying for other types of credit in addition to AMA PRA Category 1 credit? No Yes (please indicate which types of credit below) AAFP (American Academy of Family Physicians) ACOG (American College of Obstetricians and Gynecologists) AOA (American Osteopathic Association) APA (American Psychological Association) other, please specify: Please provide the Division of CME with a copy of your approval letter from AAFP, ACOG, AOA, or APA, if applicable. CME Application 2011