Welcome to the online training manual for departmentally managed activities sponsored by the Vanderbilt School of Medicine. Departmentally managed activities are typically one to three day conferences planned and implemented by Vanderbilt faculty and staff. The target audience for such conferences is most often non-Vanderbilt physicians.
The information below is designed to serve as a step-by-step process to guide you through the application for and implementation of your CME-certified activity. Forms and resources (titles of which are italicized) for each step are listed in the appropriate sections, and may be found on either the Required Forms or Supplemental Resources page of this website.
Designation of Credit
Recruitment Materials
Commercial Support
Exhibitors
Faculty Financial Relationships
Disclosures to CME Activity Participants
Syllabus/Handouts
Evaluation
Finances
Registration and Attendance
Close-out Packet
Record Retention
Designation of Credit
An Application for Sponsorship and Credit Designation of a CME Activity form must be completed before your activity can be considered for credit. In addition to the completed/signed form, the following materials must be submitted to the Vanderbilt Division of CME (VCME):
- Documentation for performance gap
- Completed/signed Disclosure of Financial Relationships forms for each Course Director and (content) Planner
- Preliminary schedule or agenda
Other requirements include:
- Review of VCME and Accreditation Council for Continuing Medical Education (ACCME) guidelines
- Registration by the CME Associate in the VCME Learning Management System as follows:
1. On the left side of this webpage, click “Sign up”
2. Enter your CME Registration data and click “Add”
3. Complete all pertinent fields on the CME User Profile page
4. Click “Save” before exiting the page
5. Send an email to cme@vanderbilt.edu stating that you have created your User Profile.
- Completion of all requirements at least six months prior to activity start date. Credit will not be awarded if applications are submitted less than three months prior to the activity start date.
The Division of CME at Vanderbilt School of Medicine is accredited to provide AMA PRA Category 1 credit for physicians (MDs and DOs). For information on other types of credit and the organizations that offer them, visit the Supplemental Resources page of this website.
Recruitment Materials
Recruitment materials include:
Required checklists for each format may be found on the Required Forms page of this website.
All recruitment materials must be reviewed and approved by the Division of CME prior to printing.
Commercial Support
NOTE: Applies only if you plan to request commercial support (grants) from entities that produce, market, re-sell or distribute health care goods or services consumed by, or used on, patients. Grants from non-profit organizations, including governmental agencies, are exempt from these guidelines.
Prior to solicitation of commercial support, you must provide us with a list of possible supporters and requested amounts.
If your approved CME activity receives educational grants from pharmaceutical companies and/or medical device manufacturers, a signed letter of agreement (LOA) must be obtainedfrom each company that provides a grant before your activity begins. Because Vanderbilt School of Medicine is the accredited provider, the director of the Division of Continuing Medical Education is the only individual authorized to approve and sign an LOA.
Most companies now require online grant requests. For those who do not, we have provided you with our Letter of Agreement to use where applicable.
The procedure for soliciting commercial support is as follows:
- Inform VCME of your intent to solicit commercial support by listing potential commercial supporters on your application for credit.
- When completing grant requests – whether online or off line – you must request payment to be made to the Vanderbilt Division of CME and sent to:
Vanderbilt Division of CME
ATTN: Don Moore or Nanette Bahlinger
320 Light Hall
Nashville, TN 37232-0260
- Advise VCME as requests for commercial support are approved or denied.
- When a grant request is approved, a company generally responds with a Letter of Agreement (LOA). This agreement must be submitted to and signed by the Director, Division of CME, prior to the activity start date. If the company does not provide an LOA, use the VCME Letter of Agreement.
- Failure to require companies to send commercial support payment to the Division of CME or failure to submit/obtain approval of the Director, Division of CME, of the LOA prior to the activity start date could result in delayed payment or credit revocation.
- Upon receipt, VCME will send checks to Vanderbilt Development and Alumni Relations (DAR) for processing. VCME will also send a copy of the check to you for your records. DAR will contact you to obtain your conference cost center number and deposit your check accordingly. All of these processes should be completed within a matter of days.
- Send VCME copies of financial reconciliations as required by commercial companies. Please do not be delinquent with reconciliation because it could interfere with other requests.
Click here to access Grant Request Information.
Click here to access ACCME Standards for Commercial Support.
Click here to access Pharmaceutical Grants Point-of-Contact List.
Click here to access Template for tracking your commercial support.
Exhibitors
NOTE: Effective July 1, 2009, exhibits will be allowed off campus only. Materials made available via exhibits must be educational in nature and devoid of company logos, if at all possible. Finally, marketing/sales representatives will be prohibited from attending educational events sponsored by Vanderbilt.
One of the most common misunderstandings is that commercial support and exhibit fees are one and the same; they are not. As stated above, commercial support is defined as “financial, or in-kind, contributions given by a commercial interest, which is used to pay all or part of”the costs of a CME activity; this support is paid to Vanderbilt Division of CME. Conversely, exhibitors pay you a fee for the sole purpose of purchasing exhibit space.
The rules regarding exhibit space must be followed and a signed Agreement to Exhibit at a CME Activity form must be obtained from each company participating as an exhibitor prior to your CME activity’s start date.
Faculty Financial Relationships
Anyone in the 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, panelists, moderators and speakers. The purpose of this form is to list any financial relationships the individual may have with a pharmaceutical company and/or medical device manufacturer.
Anyone in a position to influence the content who refuses to provide financial information cannot be permitted to participate in the CME activity.
All speakers must complete a Speaker Information form. The purpose of this form is two-fold: it provides you, the coordinator, with information about any special needs the speaker may have regarding their presentation and it provides the Division of CME with information about the content of their talk.
Click here to access Template for tracking your faculty forms.
All Disclosure of Financial Relationships forms and Speaker Information forms must be submitted to the CME office at least four weeks prior to your activity’s start date.
Disclosures to CME Activity Participants
Financial Relationships
If a speaker indicates that a financial relationship relative to the content of his/her presentation exists, the course director will receive an email from VCME indicating that a review of the presentation is required. It is the responsibility of the sponsoring department to obtain presentations. Following his/her review, the course director will advise VCME of the results by completing and submitting a Conflict of Interest Review
form. Based on the results, the Division of CME will provide the appropriate disclosure verbiage.
Whether or not course directors, planners, speakers, moderators, panelists, etc. have financial relationships, the ACCME requires the disclosure of that information to the audience prior to the CME activity.
If all faculty members have no financial relationships to disclose, please add the following statement to your syllabus/handout:
All course directors, planners, and speakers indicated no financial relationships to disclose.
If any faculty members have financial relationships to disclose, please add the following statement to your syllabus/handout:
All course directors, planners, and speakers have no financial relationships to disclose with the exception of the following:
((Add Speaker Name 1)): ((Add Company Name/Names)) – ((Add Relationship Role/Roles))
((Add Speaker Name 2, etc.)): ((Add Company Name/Names)) – ((Add Relationship Role/Roles))
Vanderbilt CME has determined that there are no conflicts of interest.
Example: All course directors, planners, and speakers have no financial relationships to disclose with the exception of the Ann Smith, MD, who is a consultant for XYZ Pharmaceuticals. Vanderbilt CME has determined that there are no conflicts of interest.
Information about financial relationships or lack thereof must be presented to the audience in the following two ways:
- Speaker slide (inserted at the beginning of each speaker’s presentation)
- Syllabus/Handout
Off-label or Investigational Uses of Drugs or Medical Devices
- Each speaker is required to identify off-label uses or investigational uses of drugs or medical devices when he or she mentions them during a presentation in an approved CME activity.
- An accredited CME provider (Vanderbilt) is required only to inform each speaker that he or she must notify the audience each time that he or she mentions an investigational or off-label use of a product or device.
- The Disclosure of Financial Relationships form contains this notification. Asking speakers to complete and sign the form meets this requirement.
All Disclosure of Financial Relationships forms must be submitted to the CME office at least four weeks prior to your activity’s start date.
Commercial Support
Whether or not your activity receives commercial support, the ACCME requires the disclosure of that information to the audience prior to the CME activity.
If your activity receives commercial support, please add the following statement to your syllabus/handout:
Vanderbilt School of Medicine ((Add Department and/or Division)) expresses appreciation to the following companies for their support of this educational activity by providing an unrestricted educational grant:
((Add Company Name 1))
((Add Company Name 2, etc.))
Example: Vanderbilt School of Medicine, Department of Pediatrics, Division of Neonatology, expresses appreciation to XYZ Pharmaceuticals for their support of this educational activity by providing an unrestricted educational grant.
If your activity receives in-kind commercial support, please add the following statement to your syllabus/handout:
Vanderbilt School of Medicine ((Add Department and/or Division)) expresses appreciation to the following companies for their in-kind support of this educational activity by providing equipment:
((Add Company Name 1))
((Add Company Name 2, etc.))
Example: Vanderbilt School of Medicine, Department of Pediatrics, Division of Neonatology, expresses appreciation to XYZ Medical Device Company for their in-kind support of this educational activity by providing equipment.
If your activity does not receive commercial support, please add the following statement to your syllabus/handout:
This CME activity received no commercial support.
Information about commercial support must be presented to the audience in the following way:
Exhibits
If your off-campus activity will host commercial exhibitors, the ACCME requires the disclosure of that information to the audience prior to the CME activity.
If your activity allows exhibits, please add the following statement to your syllabus/handout:
Vanderbilt School of Medicine ((Add Department and/or Division)) expresses appreciation to the following companies for their support of this educational activity by providing exhibit fees:
((Add Company Name 1))
((Add Company Name 2, etc.))
Example: Vanderbilt School of Medicine, Department of Pediatrics, Division of Neonatology, expresses appreciation to XYZ Pharmaceuticals for their support of this educational activity by providing exhibit fees.
Information about exhibitors must be presented to the audience in the following way:
Syllabus/Handouts
Refer to the Syllabus Checklist and Handout template on the Required Forms page of this website for details of the CME content to be included.
More and more meetings are replacing paper syllabi with electronic syllabi. No matter the medium, however, the syllabus checklist is still applicable. Meetings that choose to produce electronic syllabi are required to distribute the VCME handout on site. Distribution of a course schedule or agenda is also suggested.
A copy of the course syllabus and/or handouts must be included in your CME Activity Close-out Packet.
Evaluation
All individuals requesting credit must be asked to evaluate your approved CME activity. Not all attendees will return completed evaluation forms, and a 100% response rate is not required. A sample evaluation form is available, but we encourage you to develop an evaluation strategy that best meets your needs. At a minimum, the following questions must be asked:
- Measurement of the effectiveness of the CME activity in meeting the educational objectives defined on the application for credit.
- Two questions about changing performance: Do you anticipate changing something you currently do in your practice or doing something new as a result of your participation in this CME activity? If yes, would you share with us what you intend to do differently?
- Two questions about bias: Were you made aware that this CME course received (or did not receive) support from commercial firms that produce health care products? Were you informed about the financial relationships of speaker(s) with companies that make products or provide services related to the content of their presentation? Or that a speaker(s) had no financial relationships? Examples include honorarium; research grants; stock ownership.
- One question about “off-label” uses: If the speaker mentioned off label or experimental uses of drugs or devices, did she inform the audience that the uses of the drugs and/or devices that she mentioned were either experimental or had not been approved by the FDA for the use described?
It is the responsibility of the CME Associate to compile evaluation results and submit a summary in your close-out packet. You do not need to keep individual evaluation forms after the summary has been submitted.
A copy of your evaluation summary must be included in your CME Activity Close-out Packet.
Finances
The ACCME and Vanderbilt University Department of Finance require that accurate and timely records be kept of all financial transactions related to an approved CME activity.
The Division of CME requires that finances for a CME activity be reported on the Summary of CME Finances form. Upon completion, one copy of the financial summary should be submitted to VCME in your close-out packet and the other filed in your CME documentation file.
A copy of your Summary of CME Finances must be included in your CME Activity Close-out Packet.
Registration and Attendance
Participants are no longer required to sign in. Instead, they are required to complete a Documentation of Attendance form, which is consistent with current AMA PRA guidelines.
To provide each participant in a CME activity with a certificate of attendance, we require the following information:
- Name
- Degree
- Mailing Address
- City, State, Zip
- Email address (required)
The information above is requested on the Documentation of Attendance form.
It is the responsibility of the CME Associate to transfer the information collected on the Documentation of Attendance forms onto the Summary of Attendance form.
The Summary of Attendance form must be sent to the Division of CME for entry into the Vanderbilt CME database no later than two weeks after the CME activity is completed. The Summary of Attendance form should be sent to cme@vanderbilt.edu as an email attachment.
- Please help us by identifying your CME activity correctly (see #1) on your Summary of Attendance form. We process attendance data for almost 200 CME activities per year.
- Please keep a copy of the Summary of Attendance form in your files. If the completed form is in your files, there is no need to keep the original Documentation of Attendance forms received from each participant.
- Spreadsheets that are complete and follow Division of CME guidelines will be uploaded no later than five business days after they are received.
- The Division of CME will email participants to notify them that their credit is available online.
- Participants may obtain their credit anytime, as often as they wish, at no charge, by visiting www.cme.vanderbilt.edu
Close-out Packet
Most items, including the application, recruitment materials, letters of agreement, agreements to exhibit, and financial disclosure forms must be submitted prior to the activity start date. The remaining items comprise the close-out packet and must be submitted no later than 90 days after the CME activity is completed:
- Copy of the course syllabus or handout
- Summary of Attendance (must be submitted no later than two weeks after the CME activity is completed)
- Evaluation summary
- Summary of CME finances
Upon receipt of all items, the Division of CME will complete and send you a copy of the
Close-out Review of Documentation and Administrative Requirements for an Approved CME Activity, the purpose of which is to measure the adherence of your activity to ACCME and VCME guidelines.
The items comprising the close-out packet must be submitted to the Division of CME no later than 90 days after the CME activity is completed.
Record Retention
Files and records related to CME planning and implementation must be retained for six years. These materials include, but are not limited to:
- Fully executed Application for credit (including needs assessment documentation)
- Recruitment materials (including evidence that the correct accreditation statement was used)
- Fully executed Letters of agreement (if commercial support is received)
- Fully executed Agreements to exhibit (if exhibit space is sold)
- Fully executed Financial disclosure forms (and presentation review forms if applicable)
- Copy of the course syllabus or handout (including proof of on-site disclosure)
- Summary of Attendance
- Evaluation summary
- Summary of CME finances
There is no need to keep the original Documentation of Attendance and Evaluation forms after the data have been summarized and submitted to the Division of CME.
Records related to logistical planning, such as hotel contracts and catering menus, are not required.
You are now ready to create your own activity binder. Visit the Required Forms page of this website to access a helpful Index for Departmentally Managed Binder designed to help you implement your CME-certified activity and meet the records retention requirements listed above.
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