Welcome to the online training manual for enduring materials sponsored by the Vanderbilt University School of Medicine. Enduring materials are non-live CME activities that “endure” over time. The learning experience by the physician may take place at any time in any place, rather than only at one time and in one place as at a live activity. Examples of enduring materials include monographs, DVDs and asynchronous internet activities. 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 enduring material. 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 (grants) Faculty Financial Relationships Disclosures to CME Enduring Material Participants ACCME Requirements for Enduring Materials Post Enduring Material Requirements Additional Requirements for Online CME Finances Registration and Participation Close-out Packet Record Retention Designation of Credit NOTE: Sometimes sponsors will create an enduring material from a live CME activity. When this occurs, the Accreditation Council for Continuing Medical Education (ACCME) considers the sponsor to have created two separate activities – one live event and one enduring material. In such cases, two applications must be completed and submitted. An Application for Sponsorship and Credit Designation of a CME Activity form must be completed before your enduring material can be considered for credit. In addition to the completed/signed form, the following materials must be submitted to the Vanderbilt Division of CME (VUCME): Documentation for performance gap Completed/signed Disclosure of Financial Relationships forms for each Course Director and (content) Planner Preliminary schedule (if applicable) Other requirements include: Review of VUCME and Accreditation Council for Continuing Medical Education (ACCME) guidelines Registration by the CME Associate in the VUCME Learning Management System as follows: 1. 2. 3. 4. Visit www.cme.vanderbilt.edu Click on “”Create a new CME Account" Enter your CME Registration data and click “Add” Complete all pertinent fields on the CME User Profile page (Be sure to check the box next to "Are you a new Vanderbilt CME Associate?" then click "Save") 5. Click “Save” at the bottom of the page 6. Send an email to [email protected] stating that you have created your User Profile. Completion of all requirements at least six months prior to enduring material launch date. Credit will not be awarded if applications are submitted less than three months prior to the launch date. The Division of CME at Vanderbilt University 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 may include, but are not limited to: Emails Flyers Brochures Websites A recruitment checklist 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 distribution. Commercial Support (grants) NOTE: Applies if you plan to request funding from for-profit companies and/or not-for-profit organizations. Grants from governmental agencies are exempt from these guidelines. Prior to solicitation of commercial support, you must provide VUCME with a list of possible supporters and requested amounts. If your approved CE activity receives an unrestricted educational grant from any non-government company or organization, a signed Letter of Agreement (LOA) must be obtained before your activity begins. Because Vanderbilt University School of Medicine is the accredited provider, representatives of the Division of Continuing Medical Education are the only individuals authorized to approve and sign LOAs. 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 VUCME of your intent to solicit unrestricted educational grants by listing potential grantors 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: Eric Huffman 320 Light Hall Nashville, TN 37232-0260 Advise VUCME as requests for commercial support are approved or denied. When a grant request is approved, the grantor generally responds with an LOA. This agreement must be submitted to and signed by the Division of CME prior to the activity start date. If the grantor does not provide an LOA, use the VUCME Letter of Agreement. Failure to require grantors to send payment to the Division of CME or failure to submit/obtain approval of the LOA by the Division of CME prior to the activity start date could result in delayed payment, refusal of payment, or credit revocation. Upon receipt, VUCME will send checks to Vanderbilt Development and Alumni Relations (DAR) for processing. VUCME 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. (For jointly sponsored activities, commercial support may be paid to the joint sponsors; joint sponsors must submit copies of payments to VCME as they are received. A commercial supporter cannot be the joint sponsor of a CME-certified activity.) Send VUCME copies of financial reconciliations as required by commercial companies. Please do not be delinquent with reconciliation because it could interfere with other institutional requests. Visit the Supplemental Resources page to access commercial support forms and resources. Faculty Financial Relationships 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, presenters, authors and editors. The purpose of this form is to list any financial relationships the individual may have with a pharmaceutical company and/or medical device manufacturer. Such information must be disclosed to the audience prior to the activity. (More about disclosure below.) Anyone in a position to influence the content who refuses to provide financial information cannot be permitted to participate in the CME activity. All Disclosure of Financial Relationships forms must be submitted to the CME office at least four weeks prior to the launch or distribution of your enduring material. Disclosures to CME Enduring Material Participants Financial Relationships If a course faculty member indicates that a financial relationship relative to the content of his/her presentation exists, the course director will receive an email from VUCME indicating that a review of the presentation is required. It is the responsibility of the sponsoring department (or joint sponsor) to obtain presentations. Following his/her review, the course director will advise VUCME 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, presenters, authors, etc., have financial relationships, the ACCME requires the disclosure of that information to the audience prior to the launch or distribution of the enduring material. ---If none of the course faculty have financial relationships to disclose, preface the content of your enduring material with: No one in a position to influence the content of this enduring material has a financial relationship to disclose. ---If one or more course faculty have financial relationships to disclose, preface the content of your enduring material with: No one in a position to influence the content of this enduring material has a financial relationship 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: No one in a position to influence the content of this enduring material has a financial relationship to disclose with the exception of Ann Smith, MD, who is a consultant for XYZ Pharmaceuticals. Vanderbilt CME has determined that there are no conflicts of interest. 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 enduring material. 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 presenters 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 the launch or distribution of your enduring material. Commercial Support Whether or not your enduring material receives commercial support, the ACCME requires the disclosure of that information to the audience prior to the launch or distribution of the enduring material. -----If your enduring material receives commercial support, preface the content of your enduring material with: Vanderbilt University School of Medicine ((Add Department/Division and non-accredited joint sponsor if appropriate)) expresses appreciation to the following companies for their support of this enduring material by providing unrestricted educational grants: ((Add Company Name 1)) ((Add Company Name 2, etc.)) ---Example: Vanderbilt University School of Medicine, Department of Pediatrics, Division of Neonatology, expresses appreciation to XYZ Pharmaceuticals for their support of this enduring material by providing an unrestricted educational grant. -----If your enduring material does not receive commercial support, preface the content of your enduring material with: This enduring material received no commercial support. ACCME Requirements for Enduring Materials In addition to the other required verbiage, ACCME requires that you preface the content of your enduring material with the following: Course faculty with institutional affiliation and credentials Medium or combination of media used Method of physician participation in the learning process (include learner assessment requirements) Estimated time to complete the enduring material Date of original release (and date of most recent update, if applicable) Termination date A required checklist for enduring materials may be found on the Required Forms page of this website. The information listed above must be transmitted to the learner prior to the learner beginning your enduring material. Post Enduring Material Requirements There are three post enduring material requirements: Learner Assessment Bibliographic Resources Evaluation Learner Assessment Provide an assessment of the learner that measures achievement of the educational purpose and/or objectives of the activity with an established minimum performance level. Examples include, but are not limited to patient-management case studies and post-tests. Post-tests will require a minimum of three questions that address diagnosis, management, and anticipated outcomes. Communicate to the participants the minimum performance level that must be demonstrated in the assessment (preferably before the enduring material begins). ---Example: In order to be awarded credit for participating in this activity, a minimum score of 80% is required on the post-test. Bibliographic Resources Provide access to appropriate bibliographic sources to allow for further study. At least one evidencebased reference (i.e., peer-reviewed article or guideline) is required. Evaluation All individuals requesting credit must be given the opportunity to evaluate their learning experience. At a minimum, the following questions must be asked: 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: Did you experience any presentations or statements that you considered to be biased toward a company’s product or service? If yes, please describe. Due to the large variety of enduring materials, however, we ask that you contact VUCME to determine the evaluation method best suited to your format and content. Also take into consideration that a summary of evaluation responses will be required; the format of that summary will be dependent upon the evaluation method used. Contact the Division of CME to determine the learner assessment and evaluation methods best suited to the format and content of your enduring material. Additional Requirements for Online CME In addition to the other requirements for enduring materials, the following requirements apply to online CME activities: Activity location – online CME activities may not be hosted on a website owned or controlled by a commercial entity. Links to product websites – embedding links to healthcare-related company websites within the educational content of the online activity is prohibited. Advertising – advertising of any type is prohibited within the educational content of online CME activities including, but not limited to, banner ads, subliminal ads, and pop-up windows. Hardware/software requirements – hardware and software requirements must be transmitted to the learner prior to the start of the online activity. Contact information – contact information must be made available to the learner. Policy on privacy and confidentiality – the direct/joint sponsor must adhere to and inform the learner of the following policy: Personal information is used for issuing a CME credit certificate and storing that credit in the Vanderbilt CME database. Copyright – documentation that the direct/joint sponsor owns the copyright for, or has received permissions for use of, or is otherwise permitted to use copyrighted materials within a CME activity on the Internet. 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 enduring material. The Division of CME requires use of the Summary of CME Finances form for reporting financial data. Upon completion, one copy of the financial summary should be submitted to VUCME 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 Participation To provide individuals with credit for their participation in your enduring material, we require the following information: Name Degree Mailing Address City, State, Zip Email address (required) Because of the variety of enduring materials, however, we ask that you contact VUCME to determine the best method to record the registration and participation of your learners. Whichever method is used, however, the Division of CME will email participants to notify them that their credit is available online. Participants may then obtain their credit anytime, as often as they wish, at no charge, by visiting www.cme.vanderbilt.edu Contact the Division of CME to determine the best method to record the registration and participation of your learners. Close-out Packet Most items, including the application, recruitment materials, letters of agreement, and financial disclosure forms must be submitted prior to the launch or distribution of your enduring material. The remaining items comprise the close-out packet and must be submitted no later than 90 days after the CME credit for the enduring material has expired: Evaluation summary Summary of CME finances Upon receipt of all items, the Division of CME will complete and send you a copy of the Review and Close-out of an Approved CME Enduring Material, the purpose of which is to measure the adherence of your enduring material to ACCME and VUCME guidelines. The items comprising the close-out packet must be submitted to the Division of CME no later than 90 days after the CME credit for the enduring material has expired. 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) Fully executed Partnership Agreement (applies to joint sponsors only) Recruitment materials (including evidence that the correct accreditation statement was used) Fully executed Letters of agreement (if commercial support is received) Fully executed Financial disclosure forms (and presentation review forms, if applicable) Proof that ACCME enduring materials policy requirements were met Proof that ACCME Internet policy requirements were met (if applicable) Learner assessment summary Evaluation summary Summary of CME finances You are now ready to create your own enduring material binder. Visit the Required Forms page of this website to access a helpful Index for Enduring Material Binder designed to help you implement your CME-certified enduring material and meet the records retention requirements listed above.