Pharmaceutical Sponsorship Request Letter Template - DOC by ytm52584

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									                                    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           To be completed by VCME
Telephone                         615-322-0672                            Telephone
Fax                               615-322-4526                            Fax
Email         nanette.bahlinger@vanderbilt.edu                            Email




Subm ission
1.    The information on this form is the result of educational and administrative planning associated w ith 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 betw een 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 servic es 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                                                                                                Date




Approved for      _____      AMA PRA Category 1 Credits                                                             Fee:    ________


Director, Division of CME:          _________________________________________                                      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.”
         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.


2.       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 inform ation 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
                                practic e or demonstrates application of the content in a simulated practic e environment or educational
                                setting. Go to item #5.
             Perform ance      Physicians actually apply the content of this CME activity in their practic e 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 w ill 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 know ledge, 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 inform ation about current and desired levels?

                                                              Desired       Current
               Method:                                                                  Exam ple of expected documentation:
                                                              Levels        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 pathw ay                                   Table of contents or executiv e summary
               Other, _____________________________                           

     d.   Based on the results that you w ant 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.

                  Physician participants are provided w ith 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 w ith 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 w ith 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:

     f.   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 w ill 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.

     Perform ance means that physicians actually apply the content of this CME activity in their practice settings


     a.   Please describe the perform ance 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 perform ance 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 inform ation about current and desired levels?

                                                                Desired      Current
               Method:                                                                 Exam ple of expected documentation:
                                                                Levels       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 pathw ay                                  Table of contents or executiv e summary
               Other, _____________________________                            

     d.   Based on the results that you w ant 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.

                  Physician participants are provided w ith 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 w ith 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 w ith 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:

     f.   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 w ill be addressed by this CME
     activity.

             Patient Care that is compassionate, appropriate, and effective for the treatment of health problems and the
            promotion of health

            Medical Knowledge about established and evolv ing 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 w ith 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 div erse 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 effectiv ely call on system resources to provide care that
             is of optimal value



8.   Identify the speaker(s), panelists , moderators, etc, and tell us their institutional affiliation and academ ic 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 subm itted 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 inform ation in the budget form at below :
          No direct costs associated w ith this CME activity; no budget is prepared


     REVENUE                                                                             BUDGET ED              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                                                                     BUDGET ED              ACTUAL
          Speaker Expenses
          Speaker Fees (detailed listing required on follow ing page)
          Staff Expenses
          Recruitment Expenses (brochure, etc.)
          Food and Beverage Servic e
          Facilities
          Course Materials
          Audio-visual
          Other Expenses, Specify:

     TOTAL DIRECT EXPENSES


     INDIRECT EXPENSES                                                                   BUDGET ED              ACTUAL
          CME Fee
          IDS Tax
          Other Indirect Costs, Specif y:
     TOTAL INDIRECT EXPENSES


     TOTAL EXPENSES (DIRECT + INDIRECT)                                                  BUDGET ED              ACTUAL




     DIFFERENCE (TOTAL REVENUE – TOTAL EXPENSES)                                         BUDGET ED              ACTUAL




     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 w ill be receiving a speaker’s fee (honorarium) and the amount of the fee,
     and all speakers whose expenses related to their partic ipation in this CME activity w ill be reimbursed.

     Vanderbilt CME policy on speaker fees limits w hat 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.


                                                                                                     Request       Reason for
                                                                          Speaker Fee               Exception      Request
                                                      Expenses            Amount
      Speaker                                                                                                      Select from
                                                      Amount
                                                                          (See Below .)            No     Yes      list at bottom
                                                                                                                   of page.




     Vanderbilt CME Speaker Fee policy

     1.   Policy recommended range for speaker fee: $500 to $2,500.
     2.   Policy recommendation that Vanderbilt faculty not receive speaker fee.

     Reasons to request an exception to Speaker Fee policy:

     1.   One of the very few people who can address this topic .
     2.   Speaker is involved in multiple presentations, panels, workshops in this CME activity.
     3.   Significant time aw ay 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.

NOT E: 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.”

NOT E: Effective July 1, 2009, grants for CME-certified activities must be made payable to and processed by the Vanderbilt
Division of CME.

     Company                                                                                                Am ount 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 m inimum , the following terms w ill 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.

NOT E: 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.”

NOT E: Effective July 1, 2009, marketing/sales representatives will be prohibited from attending educational events
sponsored by Vanderbilt.

     Company                                                                                                Am ount 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 w ill disclosures be m ade to the audience? (Select all that apply)
     Speaker &       Commercial
      Planner         Support/No
      Financial      Commercial
    Relationships       Support

                                    In materials distributed to partic ipants as part of the course syllabus/handout
                          N/A        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 m aterials.


                                                                                                               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 w aived registration fees can be
     offered. Reducing or w aiving registration fees can be perceived as an attempt to influence referrals to Vanderbilt
     physicians.



15. How w ill participants be recruited to register for this CME activity? Check all that apply.

NOT E: 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 w eb 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 advertis ing
      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 whic h types of credit below)

                         AAFP (American Academy of Family Phy sicians)
                         ACOG (American College of Obstetricians and Gy necologists)
                         AOA (American Osteopathic Association)
                         APA (American Psy chological Association)
                         other, please specify:

     Please provide the Division of CME w ith a copy of your approval letter from AAFP, ACOG, AOA, or APA, if applicable.




                                                                                                             CME Application 2011

								
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