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A series
activity consists of multiple meetings (in a defined time
period) focused on a single topic or discipline. The target
audience is internal (Loyola/Hines) physicians and external
(local, regional, national) physicians. However, the actual
audience attending must remain the same for each session.
Loyola
University Chicago, Stritch School of Medicine, Division of
Continuing Medical Education is accredited by the
Accreditation Council for Continuing Medical Education (ACCME)
to sponsor continuing medical education for
physicians. The Division of CME has developed the following
policies to guide the planning process and ensure the quality
of each Loyola CME Category 1 educational activity.
Activity Review
All
Series activities are reviewed and approved by the CME
Committee. The committee’s responsibilities are to: (1)
provide oversight for the conduct of Loyola Stritch School of
Medicine continuing medical education activities; including
review and approval of continuing medical education courses,
(2) insure that continuing medical education courses comply
with Loyola’s policies and procedures and are supportive of
the CME Mission and (3) provide recommendations to the course
directors.
Needs Assessment
Each
activity must identify the educational needs (knowledge,
competence or performance) that underlie the professional
practice gaps of the learners and are the basis for the
educational activity. The needs of the learners are the basis
for developing the learning objectives of the activity. The
activity objectives are best framed using concrete and
specific language that communicates, in active rather than
passive terms, the abilities that learners should acquire as a
result of the learning activity. This in turn allows the
participant to evaluate the activity with respect to their
educational needs.
Educational Methodology
The
design of the educational activity should accommodate the
identified learning needs and the stated learning objectives.
The methods used should consider the target audience,
knowledge level (skill level) of the participants, and be
appropriate for the activity objectives. All clinical
recommendations must be based on evidence that provides
adequate justifications for their indications and
contraindications in the care of patients.
Activity Evaluation and/or Outcomes
An
evaluation method must be selected and conducted at the
conclusion of the activity to initially measure the success
and the intended outcome of the activity. Three-four months
post-activity a second outcome analysis will be conducted for
the activity by the CME office. The purpose of the second
analysis is to establish the extent to which the activity
advanced physician competence, enhanced practice performance
or improved healthcare outcomes in patients. A summary of the
results will be provided to the activity director.
Accreditation from Other Disciplines
It is
acceptable for the sponsoring department to apply to
disciplines that do not recognize CME credit (i.e. nursing,
social work, podiatry, etc.) to request accreditation from
that entity for an activity. All inquiries and applications
must be done by the sponsoring department. The Division of
CME does not apply to outside organizations for credit.
Disclosure
Any person having control of content at sponsored CME
activities must disclose to participants the presence of
financial relationships with commercial companies whose
products are discussed in their activity. This includes
course directors, planning committee members, speakers and
moderators. ACCME focuses on financial relationships
occurring in the 12 months proceeding the time the individual
is being requested to assume a role in controlling content of
the CME activity. Relationships include: grants or research
support; employee; consultant; stockholder; or member of
speakers bureau. Disclosure information is presented to the
audience in printed handout material. If a speaker refuses
to disclose relevant financial relationships, the course
director must disqualify them from being a part of the CME
activity.
Speakers
must also disclose if they are discussing products that are
investigational or not labeled for use under discussion.
Presentations by themselves, or in conjunction with other
presentations, must give a balanced view of the therapeutic
options. Use of generic names of products contributes to
impartiality. If trade names are used, those of several
companies should be used.
Course
director must disclose any financial relationships the Loyola
sponsoring department has with commercial companies whose
products are discussed or who are supporting the educational
activity.
The
disclosure of a relationship does not suggest or condone bias
in any presentation. Disclosure is to provide participants
with information that might be of potential importance to
their evaluation of a presentation.
Conflict of Interest
The ACCME defines a conflict of interest as present when a
planner, speaker or author has BOTH a financial relationship
with a commercial interest and the opportunity to affect
content relevant to products or services of that commercial
interest. The purpose for identifying and addressing
potential conflict of interest is to ensure a proper balance,
independence, objectivity and scientific rigor of the
educational activity. Any conflicts of interest identified
must be resolved in order for the individual to participate in
the activity.
Honoraria
It is
appropriate to give individuals conducting, planning and
speaking at CME activities a reasonable honorarium. The
principle for setting guidelines for honorarium amounts is to
compensate those individuals who contribute to the content of
an activity. Honoraria amounts vary widely due to medical
specialty, location of the activity, level of participation in
planning the activity, number of lectures, etc. Therefore
the honoraria amounts are to be determined by the course
director and his/her department chairman. The CME Director
and CME Review Committee will determine whether the honoraria
amount is considered reasonable. If any honorarium exceeds
$3000 the course director must submit a written explanation to
the CME Review Committee when submitting the CME Application.
Commercial Company Support
The Accreditation Council for Continuing Medical Education
(ACCME) Standards for Commercial Support of Continuing Medical
Education must be followed regarding commercial influence in
the planning, design, and implementation of CME activities at
Loyola University Medical Center. The role of the commercial
company in supporting CME is to facilitate conduct of an
activity by providing funding to support an activity. Loyola
as the accredited sponsors are responsible for the content
quality and scientific integrity of all CME activities
certified for credit. The following policies define the
actions of Loyola and commercial company personnel in
conducting CME activities:
1.
Commercial financial support may be used for a) honoraria for
activity faculty (amount decided by activity director), b)
travel, lodging, meals for activity faculty, c) meals,
refreshments and receptions provided for activity registrants
and faculty, and d) activity expenses including, facility
rental, supplies, equipment. Commercial companies may not
pay directly for CME activity expenses (i.e. speakers travel,
honoraria, etc.).
2.
Inducements (other than meals or token gifts) are not
permissible. This would include excessive meals or social
events for participants; substantial gifts; or paying travel,
lodging, or registration fees for any activity attendees.
3.
Commercial promotional activities (i.e. exhibits),
distribution of promotional materials (product handouts,
brochures, etc.), and attendance of company representatives
are prohibited at educational sessions, meals or social
functions.
4.
Commercial companies may supply equipment, (eg. surgical
"tools" for laboratory sessions) for participant use in an
activity.
5.
Commercial company representatives do not have a
role in the following areas of a CME activity a) planning
activity content, b) selection of activity speakers, c)
contacting of speakers/faculty, and d) promotion of products
during presentation.
6.
Printed activity materials
(i.e. syllabus, brochures when possible) will list all
companies providing support for an activity. The course
director will also make acknowledgment at the activity in
opening remarks.
7. The
Division of CME administers all educational grants for all CME
activities and must be copied on any correspondence between
the activity director and commercial company representatives.
Third Party Involvement
Any
institution outside of Loyola is considered a third party;
these institutions are commercial companies or communication
companies. Loyola must control the content and presentations
of all CME activities. Educational activities must be free of
commercial bias for or against any product and the
activity related educational materials including speaker's
slides must not advance the specific proprietary interests of
a financial supporter or proprietary company. If scientific
research conducted by a proprietary company is the basis for a
presentation, then the research must conform to the generally
accepted standards of experimental design, data collection and
analysis.
Product
promotion must not interfere with the presentation of CME
activities and not be a condition of support for a CME
activity. Product promotion may not be offered to the learner
while he/she is engaged in the educational activity.
Non-Compliance
Loyola
University Chicago Stritch School of Medicine reserves the
right to withhold or withdraw accreditation from any CME
activity that is found to be non-compliant with any of the
aforementioned policies and procedures. Non-compliance may
result in sponsoring department and/or section being
ineligible for accreditation of future activities.
Activity Application
All educational
activities applying for Category 1 CME Credit must complete
the “Application for CME Activity Approval.” The application
must be submitted six months prior to the date of the
activity. The application identifies the activity’s needs
assessment, objectives, teaching methodology,
evaluation/outcomes, activity schedule, speaker information,
and budget planning form. The completed application
(including all required addendum) must be signed by the course
director and the department chairman and returned to the
Division of CME.
Budget Estimate
CME will develop a
budget estimate based on the budget planning form data from
the application. The budget estimate will be returned to the
sponsoring department for review and approval. The completed
estimate must be signed by the course director and department
chairman and returned to the Division of CME.
CME Committee Review
The CME committee
reviews all activities submitted to the Division of CME for
credit approval. The committee reviews both the "Application
of CME Activity Approval" and "Budget Estimate" for each
activity. . The Division of CME must receive the application
including all addendum (i.e. documentation supporting evidence
of need, schedule, speaker list, disclosure forms, etc) and
signed budget estimate by the 15th of the month for
review at the next committee meeting.
Approval Status
The course director
will receive written correspondence regarding the activity's
credit approval or denial, as well as, any concerns the
committee may have identified.
Activity Coordination
Series CME activities are coordinated by the sponsoring
department and as a result the CME administrative fee is
reduced.
Activity Account
The Division of CME administers an activity account for all
Series CME activities. All educational grants from commercial
companies will be managed in this account and a CME accounting
fee will be charged. If activity has no income from
commercial company educational grants, the CME accounting fee
is waived.
A per
registrant processing fee is accessed for processing credit
records.
Educational Grants
Commercial
companies may give restricted or unrestricted educational
grants for Series CME activities. The Division of CME will
manage these grants. A letter of agreement will be tendered
and signed by the commercial company representative, the
course director, and the Division of CME.
Disclosure
Course
director is responsible for obtaining a completed disclosure
response form from each individual (course director, speakers,
moderators, planning committee members, etc) participating in
the educational activity. Course director must complete a
disclosure response form for him/herself. The disclosure
information will be presented to the audience in printed
handout material. The course director must disqualify any
individual refusing to disclose from being a part of the CME
activity.
Conflict of Interest
Identifying and resolving conflicts of interest is the
responsibility of the course director. Course director is
responsible for obtaining a completed disclosure response form
from each individual (course director, speakers, moderators,
planning committee members, etc.) participating in the
educational activity. Course director must review each
disclosure response form and identify any potential conflicts
of interest. If a potential conflict is identified, steps
must be taken to resolve the conflict before the individual's
participation is secured. If the conflict is not able to be
resolved, the course director must disqualify the individual
from participating in the CME activity.
Methods to
resolve a conflict include but are not limited to:
·
Replace
topic to be presented by the individual to one in which a
conflict does not exist;
·
Limit
individual's presentation to include areas of the topic that
do not create a conflict;
·
Change
focus of topic so content is not about products or services of
the commercial interest that are the basis of the conflict;
·
Limit
individual's presentation to data and results of research
allowing another speaker to address implications and
recommendations for clinical care.
In the
case of the disclosure response form completed by the course
director, the department chair must review the disclosure
information and identify any potential conflicts of interest.
If a potential conflict is identified, dept. must take steps
to resolve the conflict before the individual can continue in
their capacity as course director. If the conflict is not
able to be resolved, the department chair must replace the
course director or postpone conference until another course
director can be identified.
The CME
committee will examine the disclosure response forms as part
of the review process to grant credit to the activity. Any
questions or concerns identified during the review process
regarding conflict of interest will be referred back to the
course director and must be addressed and resolved before CME
credit will be granted for the activity.
If a
speaker is added to the educational activity after CME credit
has been granted the course director must follow the same
procedure of obtaining, reviewing and resolving a conflict of
interest. Form is then forwarded to CME coordinator who will
review with the CME director. Any questions or concerns
identified must be immediately addressed and resolved by the
course director. If the conflict is not able to be resolved,
the course director must disqualify the individual from
participating in the CME activity.
In the
event a substitute speaker is appointed the day of the
activity, the speaker must complete a disclosure information
form and verbally disclose in the opening remarks of their
presentation. This is the only instance in which a verbal
disclosure is permissible. The course director is responsible
for verifying the speaker does not have any conflict of
interest and that the speaker verbally discloses to the
audience. Documentation of verbal disclosure must be
completed by the course director and submitted to the CME
coordinator.
Promotional
All
activity fliers must contain the accreditation statements and
acknowledge any unrestricted or restricted educational grants
supporting the activity. It is permissible to include these
statements only after CME credit has been assigned by the
Division of CME. References to "credit having been applied
for" may not be made.
ACCREDITATION STATEMENT
Loyola University Chicago, Stritch School of Medicine is
accredited by the Accreditation Council for Continuing Medical
Education (ACCME) to sponsor continuing medical education for
physicians. The Loyola University Chicago, Stritch School of
Medicine takes responsibility for the content, quality and
scientific integrity of this CME activity.
The Loyola University Chicago, Stritch School of Medicine
designates this educational activity for a maximum of [number
of credits] AMA PRA Category 1 Credit(s)™. Physicians should
only claim credit commensurate with the extent of their
participation in the activity.
Issuing of Category 1
Credit
Upon completion of activity a Certificate of Participation is
mailed to all participants 2-4 weeks following the activity
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