General CME Questions
- What is CME?
- What is considered commercial support?
- What is a Letter of Agreement (LOA) and why is it required?
- What is financial disclosure?
- What is a conflict of interest and how can it be resolved?
RSS (Regularly Scheduled Series) FAQ's
The FAQ's for our Regularly Scheduled Series will be RSS specific and broken down into several categories. These categories often overlap and you may see some of the same FAQ's in several categories. They include:
- Financial Disclosure
- Commercial Support
- Promotional Materials / Schedules
- Attendee Lists / Certificates
Continuing medical education consists of educational activities which serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships that a physician uses to provide services for patients, the public, or the profession. The content of CME is that body of knowledge and skills generally recognized and accepted by the profession as within the basic medical sciences, the discipline of clinical medicine, and the provision of health care to the public.
A Letter of Agreement (LOA) is a written agreement specifying the terms, conditions, and purposes of the commercial support awarded by a commercial entitiy to a provider. All commercial support, both monetary and in-kind, requires a letter of agreement with signature by TMHS OCME Director or CME Committee Chairman and signature by supporting company. All support must be disclosed in writing to participants prior to the educational activity. A copy of the signed LOA should be dated and received prior to the live program date or enduring format release date.
TMHS has very strict rules regarding commercial support of CME activities. If you are considering or intending to use commercial support for your activity, please contact the Office of CME prior to submitting your application to make certain your activity is in compliance with both TMHS and ACCME commercial support standards.
All individuals who are in a position to control the content of an educational activity are required to disclose all relevant financial relationships in any amount occurring within the past 12 months related both to content and to commercial supporters of the activity.
An individual must disclose to learners any relevant financial relationship(s), to include the following information:
- the name of the individual;
- the name of the commercial interest(s);
- and the nature of the relationship the person has with each commercial interest.
For an individual with no relevant financial relationship(s) the learners must be informed that no relevant financial relationship(s) exist.
Timing of disclosure
A provider must disclose the above information to learners prior to the beginning of the educational activity.
A conflict of interest is present when individuals in a position to control the content of CME (or their spouses/partners) have a relevant personal financial relationship with a commercial entity that benefits the individual and may ultimately bias the presentation of that content to colleagues and participants.
If a perceived conflict exists, it must be resolved by:
Alter financial relationships - Individuals may choose to discontinue or alter their relationship with a commercial entity and eliminate any bias associated with the proposed CME content.
Alter control over content - The individual and/or TMHS CME can elect to alter the educational design, format or content or individual responsibilities to maintain the scientific rigor, integrity and balance of the CME activity.
Peer-Review of Content - Independent review and validation of content can verify the scientific biases and integrity of the content as well as the consistency with the overall educational design. Peer review will follow these two standards:
Clinical medicine recommendations will be based on evidence currently accepted within the profession of medicine as acceptable justification for indications and contraindications for the care of patients.
- Scientific research referenced, utilized and/or included in CME activities will conform to generally accepted standards of experimental design, data collection and analysis.
A provider must resolve any disclosed conflicts of interest prior to the beginning of the educational activity using one of the methods listed above.
Q: Is there a fee to certify my activity?
A: There is no fee to TMHS departments.
Q: Once I receive certification approval, do I need to provide any other information to CME?
A: You will need to be in constant contact with CME for all recordkeeping (i.e. speaker letters, disclosures, commercial support letters of agreement, schedules, advertising, sign-in sheets, evaluations, etc.).
Q: Who has to complete a financial disclosure form?
A: A financial disclosure form must be completed by anyone who is in the position to control the content of an educational activity. This means that we definitely need a signed form from the speaker, regardless of degree, training, expertise, faculty or non-faculty status, external or internal to TMHS, etc. and anyone else who has any control of the content of the presentation.
Q: How often must the form be signed?
A: Every speaker must sign a form at least once a year (prior to the first presentation) and then as appropriate if any of the information changes within the year. The planner and/or faculty member in charge of the series should complete a form and send it as part of the CME application.
Q: May I fax the form to the speaker and receive it back via fax or must I have a signed original?
A: Faxed forms are acceptable, as are emailed forms.
Q: What if the speaker signs the form, but doesn't check any boxes?
A: You will need to re-contact the speaker to clarify whether or not they have anything to disclose. We cannot assume that they do not have anything to disclose, just because nothing was checked.
Q: What do I do after I receive the signed form from the speaker?
A: The results MUST be shared with the audience. This can be done in a number of ways: posted next to the sign-in sheet; posted as the first or an introductory slide on the screen. In addition to providing the written information, the disclosure results may also be verbally announced as part of the speaker introductions. These are just a few examples.
Q: Do I send the forms to the CME office?
A: Yes. We need the form along with evidence that the disclosure was made to the audience and how the disclosure was made.
Q: Who is supposed to sign the second part of the disclosure form?
A: If there is any disclosure information checked, the course director needs to review the disclosure and make sure that no conflict of interest exists. If there is the possibility of conflict, it must be resolved using one of methods listed on the bottom of the form and documented there and then signed by the course director before the presenter speaks.
Q: How do I secure commercial funds for my activity?
A: You will need to make a direct request to the commercial company.
Q: Where do I get a copy of the Commercial Support Letter of Agreement (LOA)?
A: You can request one from the CME office and we will email it to you.
Q: Can I or someone in my department sign the Letter of Agreement (LOA)?
A: No, the Commercial Support Letter of Agreement (LOA) must be fully executed through the Office of CME.
Q: What paperwork needs to be sent to CME?
A: We need a copy of the fully executed Letter of Agreement (LOA), after all signatures, before the activity begins.
Q: What is the correct way to acknowledge commercial support?
A: Commercial support must be acknowledged at your event. The wording to use to acknowledge commercial support should be "This activity is supported by an unrestricted educational grant from ...".
Q: Can a commercial company be listed as a sponsor of our activity?
A: No. A commercial support company should never be listed as a sponsor of an activity. They can only be listed as a "supporter".
Q: Can a commercial company provide meal(s) at our activity?
A: No, the commercial support company may provide an unrestricted educational grant from which the funds can be used to pay for a modest meal.
Q: Is there any specific wording that CME requires on the promotional material?
A: Yes. The most updated certification statement needs to be listed on any promotional material. If you receive commercial support, it must also be acknowledged.
Q: Does the CME office need updated schedules as times/dates change?
A: Yes. It is most helpful for the CME Office to be sent an updated schedule of activities. We post your activities on our website and we also attend activities for monitoring purposes.
Q: When are the sign-in sheets due?
A: Sign-in sheets are due along with all of the required documentation within one month of event.
Q: How often do we need to evaluate our program?
A: At least quarterly.
Q: Do you need all of the evaluation forms?