Guidelines for CME Sponsorship of Enduring Materials

• Identify a gap in practice of the target audience.  (What are physicians not doing that they could do that would improve their patients’ health?)  This practice gap should be identified through a needs assessment that is based on documented data.

Examples include:

• Public Health Data

• Quality Improvement/Risk Management Data

• State Mandates

• Chart Audits

• Epidemiological Data

• Healthcare Trends

• Medical Society Guidelines

• Faculty Meeting Minutes (in which faculty educational needs were discussed)

• Copies of physician Surveys

• Physician Self-Assessment

• Once a need for an activity has been identified, a planning meeting must occur involving the Activity Director, a CME Office representative, and any other party to be involved in the planning and execution of the Activity.  To ensure that this activity is in keeping with the ACCME Essentials and Standards, and the mission of the NYMC Office of CME, this meeting must take place prior to any activity development.  A CME identification number for this activity will be assigned at this meeting.

Submit the following items to the CME office at least 12 Weeks Prior to the launch of the activity:

• Completed Application for CME Sponsorship of Enduring Materials.
• Supporting Documentation for the Needs Assessment.
• Copies of program faculty invitation or confirmation letters. (Letters must indicate activity title and specific topic(s) and objectives.
• Completed Commercial Support Agreement Form for EACH company supporting any activity.
• Completed Financial Disclosure statements for each activity faculty and planning member.  Any person who refuses to disclose significant financial relationships may NOT participate in the planning or presentation of a CME activity.  Activity faculty or planning members who indicate they have a relationship with a commercial entity will be asked to sign a Good Practices Agreement in order to continue with their involvement in the activity.
• Complete activity content (manuscripts, PowerPoint Presentations, Audio, etc.) for review by NYMC CME Committee member.
• Copies of advertisements and Program Packaging.

Program Packaging must include:

1. Specific Objectives

2. Target Audience

3. Principal Faculty and their credentials

4. Medium or combination of media used

5. Method of physician participation in the learning process

6. Estimated time to complete the educational activity

7. Dates of original release and most recent review or update, or dates Valid for CME credit

8. Financial Disclosure Statement for each activity faculty and planning member regarding financial relationships and off-label discussions pertaining to this activity.  Note, any faculty or planning member who refuses to disclose significant financial relationships may NOT participate in the planning or presentation of the CME activity.

9. CME Accreditation Statements:

For Directly Sponsored Materials:

“New York Medical College is accredited by the ACCME to provide continuing medical education for physicians.  New York Medical College designates this educational activity for a maximum of {enter # of credits here} AMA PRA Category 1 Credit(s)™.  Physicians should only claim credit commensurate with the extent of their participation in the activity.”

 For Jointly Sponsored Materials:

“This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council For Continuing Medical Education through the joint sponsorship of New York Medical College and {Enter name of Joint Sponsor}.  New York Medical College is accredited by the ACCME to provide continuing medical education for physicians.  New York Medical College designates this educational activity for a maximum of {enter # of credits here} AMA PRA Category 1 Credit(s)™.  Physicians should only claim credit commensurate with the extent of their participation in the activity.”

10.  Disclosure Statement:

“All activity faculty and planners participating in continuing medical education activities sponsored by New York Medical College are expected to disclose to the audience any significant support or substantial relationship(s) with providers of commercial products and/or devices discussed in their presentation and/or with any commercial supporters of the activity.  In addition, all faculty are expected to openly disclose any off-label, experimental, or investigational use of drugs or devices discussed in their presentations.”

11. Acknowledgement of any commercial support received for the activity.  This acknowledgement must be placed at the beginning of the activity.

“We gratefully acknowledge {Insert name of commercial supporter} for their generous support of this educational activity.”

12. Contact information for potential participants both for the author and for administrative assistance (CME office).

13. Evaluation methods for the activity, including assessment of the participants’ understanding of the content and applicability of the material presented.

14. Instructions how to receive credit for participating in the activity, which must include:

• The evaluation method

• The cost, if any, to receive credit

• The dates valid for CME credit

• The requirement for the completion of the participant attestation statement

• The address to which to send materials that are required to obtain credit

* Note:  The Activity must not include product specific references or advertising.

Once the Activity has been approved:

• Submit 10 copies of the finished product (monograph, CD-ROM, etc.)

• Participants’ Original attestations, evaluation forms, and assessment forms must be submitted to the CME Office before credit may be issued.

• 4-6 months following the activity, document changes in learners’ competence, performance, or patient outcomes achieved as a result of this activity.  This may be achieved through:

• Follow up survey

• Review of QI data

• Chart Review

• Hospital Discharge Data

Additional Requirements for Internet CME Activities:

• A link to the Internet Privacy Statement/Policy must appear in the opening screens

• The Activity Must Not:

  • Reside on a pharmaceutical or device manufacturer’s product website

  • Include links within the activity to a pharmaceutical or device manufacturer’s website

  • Contain advertising within the educational portion of the activity

revised: 6/03/08