Policies

Application Instructions:

The Elsevier Office of Continuing Medical Education (EOCME) has been accredited as a CME provider by the Accreditation Council for Continuing Medical Education (ACCME). As an accredited provider, the EOCME may also joint sponsor/co-sponsor activities with other organizations. Accredited providers must operate in compliance with the Essential Areas and policies and Standards of Commercial Support of the ACCME.

The EOCME holds its joint sponsored/co-sponsored activities to the same standards as its directly sponsored continuing education activities in terms of planning, evaluation, commercial support and program administration. In requesting that an activity be joint/co-sponsored, the non-accredited/accredited entity (joint/co-sponsor) shall submit a completed EOCME application for approval and agree to meet the conditions listed below. Upon approval of the application by the EOCME Director, a written joint/co-sponsor Letter of Agreement (LOA) is signed by all parties involved (Provider, Joint/Co-Sponsor and Commercial Supporter).

APPLICATION
The application for approval of an accredited CME activity is enclosed. This form must be completed in its entirety, signed and returned with a cover letter requesting joint/co-sponsorship if applicable. Applications must also include documentation of needs assessment, learning/educational objectives, course design, preliminary budget, and proposed agenda in order to be reviewed. Incomplete applications will be returned. An EOCME staff member will be able to assist in the application process upon request.

All potential joint sponsors/co-sponsors will be examined on their individual merits. Although all joint sponsor/co-sponsored activities must comply with the policy on joint/co-sponsorship, the EOCME reserves the right to refuse to enter into joint sponsorship with a non-accredited organization for any reason whatsoever.

INVOLVEMENT
A member or representative of the EOCME staff must be directly involved with the planning, evaluation and administration of the activity and be on-site for all jointly sponsored activities to ensure compliance with ACCME Essential Areas and policies including the Standards for Commercial Support.

PLANNING

• The activity must be developed in response to the educational needs of potential participants or unmet needs of a particular therapeutic category.
• All Faculty must have made full disclosure to provider. All conflicts of interest (COI) must be resolved.
• The purpose/goal(s) of the activity is/are clearly stated and supported by the educational design.
• The educational objectives define the expected outcomes for the learner.
• Content is related to and consistent with the activity objectives. Each objective has corresponding content.
• Time allotted for the content is consistent with the objectives and appropriate for the content being presented.
• Faculty have knowledge and expertise in the content area and take an active part in planning their presentations.
• Teaching strategies are congruent with the objectives and content to be presented
• The site for the activity will accommodate teaching strategies, environmental comfort, and target audience accessibility.
• Criteria for verifying participation and successful completion for the learning activity are specified.
• There is a clearly defined method of evaluation.
• There is documentation of participation.

If approved, notification of approval will be sent to the joint/co-sponsor. An EOCME Project Number will be assigned and the PHASE II Instructions/Packet will be sent to the joint/co-sponsor. The EOCME will provide you with the following documents:

Required documents

• Letter of Agreement (LOA)
• Joint/Co - Sponsorship Agreement
• Grant Request Letter Sample
• Faculty Disclosure Form and Conflict of Interest FAQ

Templates

• Front/Back Matter and Activity Promotion/Brochures for
  • Live Activities Internet Publications
  • Enduring Materials
    

REQUIRED DOCUMENTATION PROCESS:

It will be the responsibility of the joint/co-sponsor to provide all information required, acquire the signatures of all parties involved, and return the Letter of Agreement (LOA), Joint/Co-Sponsorship Agreement, and a copy of the Grant Request Letter to the EOCME within 30 days after receipt of the PHASE II packet from the EOCME.

If documents are not received and no contact is made with the EOCME the approval will be rescinded. Please contact the EOCME directly. Special cases may apply.

Letter of Agreement (LOA), Joint/Co-Sponsorship Agreement, Grant Request Letter
Upon approval of the application to award credit, the responsibilities of the non-accredited sponsor will be clearly enumerated in a joint/co-sponsorship/commercial support letter of agreement. If the non-accredited/accredited sponsor or commercial supporter fails to meet its obligations as described in the EOCME LOA or fails to comply with this policy, the EOCME will withdraw from any joint/co-sponsorship relationship.

Faculty Disclosure
All faculty participating in any sponsored CME activities are expected to disclose to the activity audience any real or apparent conflict(s) of interest that may have a direct bearing on the subject matter of that activity. This pertains to relationships with pharmaceutical companies, biomedical device manufacturers, or other commercial entities whose products or services are related to the subject matter of the presentation. This also pertains to relationships with the commercial supporter of the CME activity. In addition, should the faculty’s presentation include discussion of any unlabeled use of a commercial product, you are required to disclose this to the participants. All faculty involved must receive, complete and sign the Faculty Disclosure Form. All Disclosure Forms must be submitted to the EOCME before final printing of activity materials and date of activity. Faculty who refuse to disclose will not be eligible to participate.

Faculty Communications
Faculty communications correspondence (invitations, confirmations, etc) can be redesigned to meet specific activity criteria, but all required language and statements must remain. Correspondence should include learning objectives, intended audience, and the faculty’s responsibilities and requirements for participation.

Front/Back Matter and Activity Promotion/Brochures for Publications, Internet, Live Activities, and Enduring Materials
To assure compliance with ACCME and EOCME policies, the EOCME must review the draft of your Front/Back Matter or Activity Promotion Materials before they are finalized for distribution. A draft copy must be forwarded to the EOCME as soon as it is available. Flyers, advertisements, and posters have different requirements and must also be reviewed and approved by the EOCME.

Rule of thumb- anything that will be handled or viewed by the public must be approved by the EOCME. All will be reviewed; any necessary corrections will be noted and returned for revision. Under no circumstances should any promotional material and/or programs be distributed indicating that the program has been approved for continuing education credit prior to official written notification from the EOCME.

Logos: The EOCME logo and joint/co-sponsors logo should be used on promotional materials.

TESTS:
Although tests are not a requirement, except for journal-based CME, it is a good measure that medical professionals have thoroughly reviewed & processed the activity material. If a test is included in the activity, all questions and answers must be reviewed and approved by the EOCME. Revisions will be made and returned to the joint/co-sponsor if necessary. If assistance is needed, please contact the EOCME directly.

EVALUATIONS
An evaluation form is mandatory for all jointly/co-sponsored activities. Templates are included with the specific activity (i.e., journal format, internet format, etc). If additional customization is needed, please contact the EOCME directly. Evaluation forms must be completed following the activity and returned to the EOCME to be summarized. A summarized report will be sent to the joint sponsor after the completion of the project.

CERTIFICATES OF COMPLETION
An EOCME staff member or designee at the end of the activity will mail, fax, or email a certificate of completion to participants that have either registered and attended the entire activity, participated in an activity, nor qualifies for credit after passing (70% passing is mandatory) the prescribed test. Certificates will be prepared and mailed/emailed to on-site registrants after the live activity.

ON-SITE SUPPORT
All joint/co-sponsored meetings must have an EOCME Staff member or designated representative on site for the entire meeting to ensure compliance with the ACCME Essential Areas and policies and the Standards for Commercial Support. The on-site staff member will review all presentations, ensure full disclosure of faculty to the participants before the activity begins, and monitor the place/space of the activity. The on-site staff member will collect and return sign-in rosters, registration forms and evaluation forms to the EOCME.

PLEASE KEEP IN MIND WITH ALL ACTIVITY MATERIALS THAT WILL REACH THE PUBLIC THE EOCME HAS FINAL APPROVAL. PLEASE MAKE SURE EVERYTHING IS REVIEWED AND APPROVED BY THE EOCME.

At the completion of the activity, you will receive the Phase III Documentation which will include a check-off list to collect and compile all relevant documentation for the EOCME’s files.