Download Journal Clubs - Office of Continuing Medical Education

Northwestern University’s Feinberg School of Medicine
Genevieve Napier
Director, Continuing Medical Education
Continuing Medical Education
420 East Superior
Arthur J. Rubloff Building
6th Floor, Suite 680
Chicago, IL 60611-3008
Phone: (312) 503-8533
Fax: (312) 503-4531
Email: [email protected]
June 24, 2017
Thank you for expressing an interest in conducting a Continuing Medical Education (CME) activity. Enclosed please find the CME
Application Packet for a Regularly Scheduled Series (RSS) to be coordinated by the sponsoring department/institution.
A CME Regularly Scheduled Series is an ongoing, regularly scheduled educational activity whose target audience is Northwestern
University’s Feinberg School of Medicine and their affiliate’s attending physicians. These activities include but are not limited to:
grand rounds, clinical case conferences, M&M and journal clubs. The format of a regularly scheduled series does not change and
maintains the same time period, meeting day, structure, etc. for the duration of the series. These educational activities are overseen by
Northwestern University’s Feinberg School of Medicine Office of Continuing Medical Education, with the management of the activity
delegated to the sponsoring department or institution.
Please complete this application only if:
- The activity is regularly scheduled, maintaining the same time period, meeting day, structure, etc.
- The Primary audience is attending physicians at Northwestern University’s Feinberg School of Medicine and the McGaw
Medical Center Affiliates. Activities conducted for and attended primarily by residents or fellows are not applicable for AMA
PRA Category 1 Credit™.
Please contact the Office of Continuing Medical Education at (312) 503-8533 for a different CME activity application, if the activity
does not meet all of the requirements outlined above.
All regularly scheduled series applications submitted for AMA PRA Category 1 Credit™ are reviewed by the CME Director and the
CME Program Specialist. Applications for new regularly scheduled series can only be submitted twice a year - January 20 or July
20. Applications must be complete, with all addendums attached for the application to be reviewed for approval. The application
identifies the activity’s needs assessment, objectives, teaching methodology, and evaluation process.
The CME application process is as follows:
 Complete the application.
 Obtain the signatures of the course director and the departmental chairman.
Attach a reference list or copy of the first page of the last three journal articles reviewed.
 Attach completed faculty disclosure forms of the course director(s) and other departmental members responsible for the
educational activity content with course director’s signature.
 Attach the activity’s evaluation with the required questions.
The approval process includes an evaluation of the educational planning process, activity content, evaluation process, and course
director’s and planning committee’s disclosure forms for possible conflict of interests. The Office of CME must receive the
application and attachments by either January 20 or July 20.
If you have any questions, please contact the Office of CME at (312) 503-8533. Thank you.
Sincerely,
Genevieve Napier
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Northwestern University’s Feinberg School of Medicine
Continuing Medical Education
Table of Contents
I.
Requirements for the Conference Content __________________________________________________ 3
II.
Requirements for Disclosure of Relevant Financial Relationships ______________________________ 3
III.
Sanctions for Failure to Disclose __________________________________________________________ 3
IV.
Policies for the Selection of the Planning Committee Members, Presenters, Moderators or Faculty ___ 3
V.
Honorarium Guidelines for Faculty _______________________________________________________ 4
VI.
Reimbursement for Travel and Accommodations for Faculty __________________________________ 4
VII.
Conflict of Interest _____________________________________________________________________ 4
VIII.
Identifying Conflict of Interest ___________________________________________________________ 4
IX.
Resolving Conflict of Interest ____________________________________________________________ 4
X.
Commercial Support Policies ____________________________________________________________ 5
XI.
Commercial Support Agreements _________________________________________________________ 6
XII.
Grant Submission and Reconciliation______________________________________________________ 6
XIII.
Helpful Hints for CME Grant Requests and Letters of Agreement______________________________ 6
XIV.
Activities Not In Compliance with the ACCME, AMA or NUFSM Policies _______________________ 7
For questions regarding the CME application or required documentation for a regularly scheduled series, please contact the Office of
Continuing Medical Education at (312) 503-8533.
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I.
Requirements for the Conference Content
All CME educational activities must be developed and presented in compliance with ACCME accreditation
requirements and the requirements of the AMA PRA program. The following definition of continuing medical
education (CME) describes what content is appropriate for activities that are certified for credit:
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.
Non-clinical subjects (e.g., office management or physician-patient communication) are appropriate for AMA PRA
Category 1 Credit™, so long as these are prepared specifically for a physician audience.
Activities that promote recommendations, treatment or manners of practicing medicine that are NOT within the
definition of CME, or known to have risks or dangers that outweigh the benefits or known to be ineffective in the
treatment of patients are not appropriate for AMA PRA Category 1 Credit™. Educational activities may describe
or explain alternative health evidence that supports the practices. However, education that advocates specific
alternative therapies or teaches how to perform such procedures, without evidence or general acceptance in the
profession that supports their efficacy and safety, cannot be designated for AMA PRA Category 1 Credit™
II.
Requirements for Disclosure of Relevant Financial Relationships
 Anyone who is in a position to control or influence content of an educational activity must disclose any relevant
financial relationships. This includes course directors, planning committee members, speakers, presenters,
moderators and the CME leadership.
 The disclosures must include any relationship occurring within the past 12 months or known to be forthcoming
in the next 12 months that relates to the content or commercial supporter(s) of the conference. The disclosure
must include the name of the individual, name of the commercial interest and the relationship between the two.
If no relationship exists, this must be disclosed in the same manner.
 The course director is responsible for verifying the speaker does not have any conflicts of interest and document
the disclosure occurred (in writing or verbally).
III.
Sanctions for Failure to Disclose
 Course directors and members of the educational planning committee must complete the faculty disclosure form
upon the submission of the CME Application.
 If a speaker, moderator and/or panelists (faculty member) contributing to the content of a CME activity fails to
communicate his/her disclosure information, they will not be able to participate in the activity. In the event a
faculty member is given the opportunity to speak at the CME activity without disclosing, the course director is
responsible to communicate (in writing) to the speaker of their violation and indicate they will not be able to
participate in any NUFSM’s CME activities for the next year. A copy of the written communication must be
forwarded to the Office of CME within one month of the activity.
 Disclosure Policies for Institutions and “In-Kind” Support: If the sponsoring medical school’s department,
affiliate or institution has a relevant relationship with a commercial company, it must be communicated to the
participants in the program handout materials. If the commercial support is “in-kind” the nature of the support
must be disclosed to the participants.
IV.
Policies for the Selection of the Planning Committee Members, Presenters, Moderators or Faculty
The NUFSM retains full control over the selection of planning committee members, presenters, moderators, writers,
editors and any other individuals involved in the development or presentation of the CME activity. Commercial
representatives may NOT provide suggestions of presenters and/or topics.
Physicians serving as planning committee members, presenters, moderators, panelists or other speakers (faculty) at a
CME activity must ensure that:
1.
Research findings and therapeutic recommendations are based on scientifically accurate, up-to-date
information and are presented in a balanced, objective manner.
2.
The content of the presentation is not modified or influenced by representatives of industry or other
financial contributors, and they do not employ materials whose content is shaped by industry. Faculty may,
however, use scientific data generated by industry-sponsored research, and they may also accept technical
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3.
4.
5.
6.
7.
assistance from industry in preparing slides or other presentation materials, provided that this assistance is
of only nominal monetary value and has no input in the actual content of the material.
The content of the activity or its related materials must promote improvements or quality in healthcare and
not a specific proprietary business interest of a commercial interest.
Presentation must give a balanced view of therapeutic options. Use of generic names will contribute to this
impartiality. If the CME educational material or content includes trade names, where available trade names
from several companies should be used not just trade names from a single company.
All conflicts of interest or biases, such as a financial connection to a particular firm or product must be
disclosed to the course director, CME Director and the activity’s participants.
When discussing unlabeled or investigational uses of a commercial product, these uses must be identified
as unlabeled.
Educational materials (such as slides, abstracts and handouts) cannot contain any advertising, trade names
or a product-group message.
V.
Honorarium Guidelines for Faculty
The NUFSM feels it is appropriate to give individuals for 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, if the speaker traveled to the conference, 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. If any honorarium exceeds $3000 per day and/or lecture, the course director must submit a
written explanation to the CME Director.
VI.
Reimbursement for Travel and Accommodations for Faculty
The NUFSM feels it is appropriate to reimburse reasonable travel, accommodations and meals for the speakers
participating in the CME activity. The Office of CME’s travel and reimbursement policies reflect those set by
Northwestern University, which is based on documentation of actual expenses that are supported by original
receipts. The NUFSM, joint sponsor or the designated education partner must pay the honoraria or reimbursement
of out-of-pocket expenses for the speaker directly. No other payment shall be given to the director of the activity,
planning committee members, speakers, authors, joint sponsors or any others involved with conducting the activity.
VII.
Conflict of Interest
The circumstances that create a conflict of interest (COI) are when an individual has an opportunity to affect CME
content about products or services of a commercial interest with which he/she has a financial relationship. The
purpose for identifying and addressing potential COI is to ensure a proper balance, independence, objectivity and
scientific rigor of the medical school’s educational activities. The medical school does not view the existence of a
financial relationship as necessarily implying bias or decreasing the value of participation in CME activities, but
must ensure that a financial interest is not a COI.
VIII.
Identifying Conflict of Interest
Upon receipt of the application, the CME Director is responsible for reviewing the course director and planning committee
member’s disclosure forms as they relate to the overall content of the educational activity.
The course director must review the speakers’ disclosure forms for conflict of interest, in conjunction with the topic they will
be presenting at the educational activity. The disclosures should be reviewed by the course director prior to the delivery of
the educational activity to allow adequate time for the resolution of COI. The course director will determine whether a
significant relationship exists that precludes a specific faculty member from participating in the CME activity.
IX.
Resolving Conflict of Interest
COI may be resolved by:
a.
Altering financial relationships – Individuals may change their relationships with commercial interests
(e.g., discontinue contracted services). Thereby eliminating any bias into the CME content.
b.
Altering control over content – An individual’s control of CME content can be altered in several ways to
remove the opportunity to affect content related to the products and services of a commercial interest.
These include the following:
1) Choosing someone else to control that part of the content. If a proposed presenter or planner
has a conflict of interest related to the content, someone else who does not have a relationship
to the commercial interests related to the content may present or plan this part of the content.
2) Change the focus of the CME activity so that the content is not about products or services of
the commercial interest that is the basis of the COI.
3) Change the content of the person’s assignment so that it is no longer about products or
services of the commercial interest. For example, an individual with a COI regarding
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c.
X.
products for treatment of a condition could address the pathophysiology or diagnosis of the
condition, rather than therapeutics.
4) Limit the content to a report without recommendations. If an individual has been funded by a
commercial company to perform research, the individual’s presentation may be limited to the
data and results of the research. Someone else can be assigned to address broader
implications and recommendations.
5) Limit the sources for recommendations. Rather than having a person with a COI present
personal recommendations or personally select the evidence to be presented, limit the role of
the person to reporting recommendations based on formal structured reviews of the literature
with the inclusion and exclusion criteria (‘evidence-based’).
Independent Content Validation – COI may be resolved if the CME material is peer reviewed and:
1) All recommendations involving clinical medicine are based on evidence that is accepted
within the profession of medicine as adequate justification for indications and
contraindications in the care of patients.
2) All scientific research referred to, reported or used in the CME activity in support or
justification of patient care recommendations conforms to the generally accepted standards of
experimental design, data collection and analysis.
Commercial Support Policies
The definition of Commercial Support is any financial, or in-kind, contributions given by a commercial interest,
which is used to pay all or part of the costs of a CME activity. A commercial interest is any entity producing,
marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients, with the
exemption of non-profit or government organizations and non-health care related companies. A commercial interest
cannot take the role of a non-accredited partner in a jointly sponsored CME activity.
The NUFSM must control the content and presentations of all CME activities. The educational activities must be
free of commercial bias for or against any product and the conference related educational materials including
speaker’s slides must not advance the specific proprietary interests of a financial supporter or proprietary company.
Educational materials, pamphlets and/or materials must not advance the specific proprietary interest of a financial
supporter of proprietary company. Educational materials, speaker slides or any other materials associated with the
conference may not include company logos, with the exception of acknowledging the companies who have provided
an unrestricted educational grant to support a CME conference.
The commercial interest cannot have stipulations attached to the educational grant, such as selecting faculty,
authors, participants, or any matters related to the content of the CME activity. 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 and be reviewed /approved by the course director
prior to the presentation. Documentation of the review process must be submitted to the Office of CME prior to the
activity date.
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.
Commercial interests may NOT be associated with:
1.
Identification of the CME need
2.
Determination of the educational objectives
3.
Selection and presentation of content
4.
Selection of all persons and organizations that will be in a position to control the content of the CME
activity
5.
Selection of educational methods
6.
Evaluation of the CME activity
All commercial support must be given with full knowledge and approval from the OCME. The course director
must make all decisions regarding the disposition and disbursement of commercial support.
All CME activities receiving commercial support must have a written agreement with terms, conditions, and purpose
of the commercial support. The letter of agreement (LOA) must be signed by a representative from the commercial
company and the NUFSM Office of CME prior to the date of the educational activity. If the Office of CME has not
received the signed LOA prior to the date of the educational activity, the company cannot be acknowledged in the
program materials and the educational grant can not be accepted.
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XI.
Commercial Support Agreements
Where financial or in-kind support from a commercial interest is involved, a Letter of Agreement must be
completed, signed by all parties and returned to the Office of CME prior to the date of the activity and prior to an
acknowledgement of the commercial company. If the Office of CME has not received the signed LOA prior to the
date of the educational activity, the company cannot be acknowledged in the program materials and the educational
grant can not be accepted. The agreement must be signed by a representative from the commercial interest and the
Provider. The Provider is Northwestern University’s Feinberg School of Medicine. The university’s Office of
General Council has designated Dr. John X. Thomas, Senior Associate Dean for Medical Education, as the
appropriate signature for commercial company’s LOA; members of the OCME are the designees for the medical
school’s LOA. The sponsoring department, affiliate or joint/co-sponsor are NOT the appropriate signature for
LOAs.
All commercial support must be given with full knowledge and approval from the OCME. The course director
must make all decisions regarding the disposition and disbursement of commercial support. Commercial company
funds may only be used for the cost of conducting the educational activity, such as travel, lodging, or speaker
honoraria.
The department coordinating the activity should request funds to be distributed to their department. If the company
must pay the Provider (NUFSM), the OCME will process the educational grant and issue the funds to the sponsoring
department, affiliate or joint/co-sponsor. Please refer to the fee structure for the fees associated with distributing
educational grants. The grant processing fees should be built into the grant request as a CME administrative fee.
XII.
Grant Submission and Reconciliation
The department, affiliate, medical education company, medical education company, joint or co-sponsor coordinating
the activity is responsible for processing the online grant submissions, reconciliations and retaining the activity’s
financial records for a period of 3 years.
Educational grant requests must be communicated to the Provider (Northwestern University Feinberg School of
Medicine) prior to the grant submission. A copy of all grant requests must be submitted to the Office of CME when
submitted to the commercial company.
Grant submissions must reflect the anticipated income and expenditures for an upcoming activity. The letters of
agreement must indicate how the funds are to be used (e.g., speaker’s honoraria, printing costs, etc.). The hosting
department is responsible for reconciling the educational grant as stated in the letter of agreement. If the letter of
agreement states the excess funds should be returned if the activity is cancelled or the activity does not require the
entire amount of grants given, the excess amount must be returned.
XIII.
Helpful Hints for CME Grant Requests and Letters of Agreement
Who is the CME Provider? The official CME Provider is Northwestern University, Feinberg School of Medicine.
NOTE: Grant checks can be made payable to the educational partner or the department presenting the activity, but
the CME Provider must be listed as the medical school.
Who is the Educational Partner? When the medical school works with an organization that is not affiliated with the
medical school in any way, then the organization (aka joint/co-sponsor) must be listed as Educational Partner. If the
activity is directly sponsored (no outside involvement), then this field will be “N/A”
Logistics: All logistical/meeting information must be filled in on the LOA before obtaining the Feinberg School of
Medicine’s Office of CME’s signature
Example:
Pfizer’s LOA asks questions about registration fees, mission statement, learning objectives,
whether grants are being solicited from other companies, etc. – this information must be
completed by the department requesting funds
Northwestern Office of CME’s LOA – contact information for educational partner (if applicable)
and commercial interest must be filled in.
What if a company is providing an educational grant AND an exhibit/display fee? Exhibits are considered
promotional and therefore exhibit funds cannot be included as part of the educational grant. The company can pay
for the grant and exhibit with 1 check, however, the actual grant agreement amount must not include the exhibit
funds. See also “CME Guidelines Related to Educational Grants and Exhibit Space”.
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Which agreement should be signed, Northwestern’s or the Company’s. It is permitted to use a commercial
company’s agreement if it meets the ACCMEs Standards for Commercial Support. If the grant amount changes,
either a new agreement must be signed or the amount changed on the original agreement, signed and dated by all
parties. Only one signed letter of agreement per company per activity can exist.
Who is authorized to sign grant letters of agreement for NUFSM CME activities? NUFSM’s letter of agreement can
only be signed by a staff member in the Office of CME. Commercial companies letters of agreement must signed
by the Senior Associate Dean for Medical Education.
What should I do if the commercial supporter asks me to accept the terms of their agreement online? Terms should
not be accepted without prior approval by NUFSM CME. As soon as you receive a notice that a grant is approved
pending acceptance of the terms, please provide NUFSM CME with your login information or a copy of the original
grant request and the electronic agreement terms. NUFSM CME will review the terms and let you know if they can
be accepted.
When can I acknowledge commercial support? The grant letter of agreement must be fully executed (signed by
NUFSM CME and the company) prior to being acknowledge in the activity’s flyer or at the activity.
Can you tell us what elements must be included in the written agreement? When there is commercial support there must be a
written agreement that:
 Itemizes how the Provider will use the commercial support in the development and presentation of the CME
activity;
 Itemizes the organizations involved in the activity (e.g., joint sponsors, education partners, managers);
 Specifies the organizational name of the commercial interest(s) that supplied the funds;
 Specifies what funds or in-kind services will be given by the commercial supporter to support the provider’s
activity; and
 Is signed by the commercial interest and the accredited provider.
XIV.
Activities Not In Compliance with the ACCME, AMA or NUFSM Policies
CME CREDIT WILL BE WITHDRAWN if the activity is not in compliance with the ACCME Guidelines for
Commercial Interest and Faculty Disclosure Policies. In addition, the Senior Associate Dean for Medical Education
will determine whether the sponsoring department, affiliate and/or joint/co-sponsor are eligible for future
accreditation.
If the ACCME receives a compliant about an educational activity not coordinated by the Office of CME, the course
director will be responsible to respond to the complaint according to the ACCME’s Procedure for Handling
Complaints located at: http://www.accme.org/dir_docs/doc_upload/5425eedc-f494-4859-9451e3b1cfabbeb8_uploaddocument.pdf, and any fees associated with the compliant.
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Northwestern University’s Feinberg School of Medicine
Office of Continuing Medical Education
Journal Club Application Cover Sheet
The following must be completed, included or attached to the CME Application before the application
can be submitted to the CME Committee for activity review:

Signatures of both the course director and the departmental chairman must be on the application form

Attach a reference list or copy of the first page of the last three journal articles

Completed faculty disclosure forms of the course director(s) and other departmental members responsible for the educational
activity content with course director’s signature

Activity evaluation form(s) to be used (Note: the required information stated under the evaluation policy).
Please send completed application to:
Genevieve Napier
Office of Continuing Medical Education
Northwestern University, Feinberg School of Medicine
420 East Superior
Arthur J. Rubloff Building
6th Floor, Suite 680
Chicago, IL 60611-3008
Phone: 312-503-8536
Fax: 312-503-4531
Revised 11/22/11
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To Be Completed by the Office of CME
Date Reviewed:
Category 1 hours:
Northwestern University’s Feinberg School of Medicine
Continuing Medical Education Application for AMA PRA Category 1 Credit™
JOURNAL CLUB
REGULARLY SCHEDULED SERIES (RSS)
Applications must be submitted to the Office of CME along with relevant attachments for review by the January 20th or July 20th.
CME Activity Title:
Activity Occurs (check one):  Weekly
 Bi-Weekly
If weekly, specify day of week (check one):  Monday
 Monthly
Other:
 Tuesday
 Wednesday
 Thursday
Will this activity be reformatted into another educational format (i.e. teleconference, DVD, video tape, etc.)  Yes
If yes, please describe:
Activity Location: Hospital
Activity Beginning Time:
Institution Sponsoring the Activity:

Children’s Memorial Hospital:

Evanston Northwestern Healthcare:

Feinberg School of Medicine:

Northwestern Memorial Hospital:

Rehabilitation Institute of Chicago:

Other, please identify:
Building
 Friday
 No
Room Number
Activity Ending Time:
Department
Department
Department
Department
Division:
Division:
Division:
Division:
List the NUFSM faculty member who is the course director.
Name:
Address:
City:
State:
Phone:
Fax:
Pager:
Zip:
E-Mail
Course directors are responsible for assuring that the educational activity is educationally sound, free of commercial influence and
fiscally responsible. The RSS course director must be familiar and comply with the ACCME’s Standards for Commercial Interests.
Other responsibilities include:
1.
2.
3.
4.
5.
6.
7.
Complying with the ACCME and NUFSM guidelines for CME activities.
Evaluating the RSS on a yearly basis.
Selecting and confirming faculty, overseeing curriculum development, and assuring that the format supports the objectives of the
activity.
Verifying that the audience is informed of the faculty disclosure.
Informing the faculty that they must disclose experimental and off-label uses to participants.
Verifying (if applicable) that the commercial company support is acknowledged at the activity.
Ensuring that all presentations are free of commercial bias. The Accreditation Council for Continuing Medical Education
encourages the use of generic names. Any mention of trade or brand names should include all products within a class of
pharmaceuticals or devices. In addition, faculty may not promote products, books or publications in which they have a
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8.
9.
commercial interest.
Precluding commercial interests from participating in curriculum planning activities or faculty selection.
Resolving conflicts of interest.
Departmental Contact Person (or the person responsible for coordinating the activity):
Name:
Address:
City:
State:
Zip:
Phone:
Fax:
E-Mail
Contact person must be familiar and comply with the ACCME’s Standards for Commercial Interests. Other responsibilities include:
1.
2.
3.
4.
5.
6.
7.
Contacting Erich Hagio Nelson, Office of CME for login privileges and training.
Collecting the speaker’s disclosure forms.
Creating promotional materials that include the learning objectives, accreditation statements, and commercial company
acknowledgement (if applicable).
Forwarding grant requests and letters of agreement to the OCME for signature prior to the activity.
Developing, implementing and summarizing an annual evaluation for the participants.
Completing and submitting to the OCME the Quarterly Report with required activity information and attachments on a quarterly
basis.
Maintaining accurate attendance records in the CME ongoing data management system.
Target Audience: The audience for RSS is limited to the department / division’s faculty members and staff.
Please identify the percentages of those who will be attending this conference.
___% Attending Physicians
____% Residents/Fellows ____% Medical Students ____% nurses, technicians, etc.
How is the content of the RSS appropriate for you participants’ scope of practice?
Identify the Core Competencies (check all that apply)
 Patient Care or Patient-Centered Care: compassionate, appropriate, and effective for the treatment of health problems and the
promotion of health.
 Medical Knowledge: established and evolving biomedical, clinical, and cognate (e.g. epidemiological and social behavioral) sciences
and the application of this knowledge to patient care.
 Practice-Based Learning: involves investigation and evaluation of their own patient care, appraisal and assimilation of scientific
evidence, and improvements in patient care.
 Interpersonal and Communication Skills: that result in effective information exchange and teaming with patients, their families and
other health professionals.
 Professionalism, as manifested through a commitment to carrying out professional responsibilities, adherence to ethical principles and
sensitivity to a diverse patient population.
 System-Based Practice: manifested by actions that demonstrate an awareness of and responsiveness to the larger context and system of
health care and the ability to effectively call on system resources to provide care that is of optimal value.
 Interdisciplinary Teams: cooperate, collaborate, communicate and integrate care teams to ensure that care is continuous and reliable.
 Quality Improvement: identify errors and hazards in care: understanding and implementing basic safety design principles such as
standardization and implications; continually understanding and measuring quality of care in terms of structure, process and outcomes
in needs; and design and test interventions to change processes and systems of care, with the objective of improving quality.
 Utilize Informatics: communicate, manage knowledge, mitigate error, and support decisions making use of information technology.
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Needs Assessment for Journal Clubs
For your convenience, the Office of CME has conducted a needs assessment to identify the educational gap, incorporate the literature
search, summarize the data cited and develop the learning objectives. Please review the information and add any additional information
that is relevant to your organization’s needs.
Educational need: Literature search
1. Inui TS. Critical reading seminars for medical residents. A report of a teaching technique. Med Care. 1981;19:122-4
2. Kitching AD. Resuscitating the cardiology journal club. Can J Cardiolo. 1992;8:520-2.
3. Yelon SL. Powerful Principles of Instruction. White Plains, NY; Longman:1996
4. Bennett KJ, Sacket DL, Haynes RB, Neufeld VR, Tugwell P, Roberts R. A controlled trial of teaching critical appraisal of clinical
literature to medical students. JAMA. 1987;257-2451-4.
5. Joorabchi B. A problem-based journal club. J Med Educ. 1984;59:755-7.
6. The evidence-based Medicine Working Group. Evidence-base medicine. A new approach to teaching the practice of medicine.
JAMA. 1992;268:2420-5.
7. Guyatt GH, Sackett DL, Cook DJ. Users’ guide to the medical literature, II; how to use an article about therapy or prevention. A: are
the results valid? The evidence-based Medicine Working Group. JAMA. 1993;270:2598-601.
8. Richardson WS, Detsky AS. Users’ guidelines to the medical literature, VII: how to use a clinical decision analysis. A: are the results
of the study valid? The evidence-based Medicine Working Group JAMA 1995;273:1292-5.
9. Richardson WS, Detsky AS. Users’ guidelines to the medical literature, VII: how to use a clinical decision analysis. B: what are the
results and will they help me in caring for my patient? The evidence-based Medicine Working Group. JAMA. 1995;273:1610-3.
Evidence: Researchers have identified an educational gap between the generation of new knowledge and the transfer of researchbased knowledge into practice. This gap exists because of varying degrees of understanding and knowledge of the research process
and experience in critiquing research and evaluating its scientific merit and clinic relevance. The journal club will address issues and
questions related to real situations that physicians deal with daily. The journal club will provide participants with an update on
medical literature, improve the clinical practice of its attendees by incorporating research into practice, and teach techniques in the
critical appraisal of medical literature.
Describe the needs assessment conducted for this RSS and target audience:
The literature search had identified a gap in knowledge and performance, please identify any additional education gaps demonstrated by the
target audience:
■ Knowledge (K)
 Competence (C)
■ Performance (P)
 Patient Outcomes (PO)
What will be addressed to close this gap in knowledge, competence, performance or patient outcomes?
This journal club will be address the gap in knowledge and performance by an ongoing review of literature by exposing our physicians
to evidence-based treatment strategies (K) with discussions centered on incorporating those strategies into their practices (P).
Please identify any additional gaps in competence, performance or patient outcomes that will be addressed in this Journal Club?
What are the potential or real barriers facing your target audience if this gap is to be addressed?
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Journal Club’s Learning Objectives identified through the literature search, select those that apply to this RSS:
At the conclusion of this series, participants will be able to:

Discuss the latest medical research

Gain critical appraisal of research-based articles

Identify problems and inadequacies in care delivery

Discuss new ideas and strategies

Reduce uncertainties that accompany complex problems and procedures

Justify current policies and practice

Provide a theoretical basis for current practice and decision making

Keep current on the medical literature.

Use research to support treatment decisions
List the learning objectives that are applicable to this RSS (the objectives must be listed on the promotional materials):
1.
2.
3.
4.
Identify the teaching strategy or educational methodology that will be used (check all that apply).
 Each session is devoted to the review of one or two paper(s) chosen; the topic is driven by encounters by faculty, residents or staff
within the institution.
 A clinical study is presented, excerpts from the study are prepared and open-ended questions are asked by the faculty.
 A case with an unresolved clinical problem is discussed; the problem selected coincides with the literature presented. Open ended
discussion regarding the validity and applicability of the study’s conclusion and whether the study has solved the original clinical
problem.
 Questions from the audience following each presentation
 Formal question and answer segment(s)
 Formal panel discussion session(s) with presentation of questions and cases from the audience
 Other:
Describe why this teaching strategy or educational methodology is appropriate to achieve your desired results:
What is the organizational structure for selecting articles, presenters, and moderators?
How is your planning process linked to your desired results?
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Evaluation / Outcomes
An evaluation method must be developed and administered at the end of the academic calendar. The following questions must be
incorporated into the activity’s evaluation:
1. Were the educational activities met? (Knowledge)
2. Will you change your practice as a result of participating in this activity? (Competence and Performance).
a. If yes, please identify the elements you plan to incorporate into your practice.
b. If no, what are the factors that are acting as barriers?
3. Was this activity fair, balanced and free of commercial bias? If there was bias, please explain.
Will any additional evaluation methods be designed to measure the effectiveness of the RSS?  Yes  No
If yes, please describe briefly
Commercial Interest
Will there be commercial companies providing funding for this activity?
 Yes
 No
If yes:
 All grant requests must be on behalf and with full knowledge of the course director.
 All grants must comply with the ACCME Standards for Commercial Interest.
 The Office of CME must be copied on all grant requests.
 A Letter of Agreement must be completed, signed by all parties and returned to the Office of CME prior to the date of the
activity and any acknowledgement. If the Office of CME has not received the signed LOA prior to the date of the
educational activity, the company cannot be acknowledged in the program materials and the educational grant can not be
accepted. The agreement must be signed by a representative from the commercial interest and the Provider. The Provider is
Northwestern University’s Feinberg School of Medicine. The university’s Office of General Council has designated Dr.
John X. Thomas, Jr., Senior Associate Dean for Medical Education, as the appropriate signature for commercial company’s
LOA; forward all LOAs to the OCME to obtain Dr. Thomas’ signature. The sponsoring department is NOT the appropriate
signature for LOAs.
 When possible, have the educational grant issued to the sponsoring department. If the company must pay the Provider
(NUFSM), the OCME will process the educational grant and issue the funds to the sponsoring department, affiliate or
joint/co-sponsor. Please refer to the fee structure for the fees associated with distributing educational grants. The grant
processing fees should be built into the activity’s budget estimate as CME administrative fees.
 Please refer to the section titled “Helpful Hints for CME Grant Requests and Letters of Agreement”.
Marketing
 Flyer
 Distribution of schedule
 Other:
 E-mail Announcement
 Pamphlet or brochure
Marketing materials must include:

ACCME Accreditation Statement and the CME Credit Designation Statement

Learning objectives

Acknowledgement of commercial support (if applicable)
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SIGNATURES:
I understand that the ACCME states that all CME activities must comply with the following requirements, and as the course director I
attest that this specific CME activity will comply with them:
A. All the recommendations involving clinical medicine in a CME activity must be based on evidence that is accepted within the
profession of medicine as adequate justification for their indications and contraindications in the care of patients.
B. All scientific research referred to, reported, or used in CME in support or justification of a patient care recommendation must
conform to the generally accepted standards of experimental design, data collection, and analysis.
C. CME activities must not promote recommendations, treatment, or manners of practicing medicine that are not within the
definition of CME, or are known to have risks or dangers that outweigh the benefits or are known to be ineffective in the
treatment of patients.
I have reviewed and understand the ACCME & NUFSM policies regarding RSS and agree to comply with those policies.
__________________________________________
Print Course Director’s Name
________________________________________________________
Course Director’s Signature
Date
__________________________________________
Print Chairman’s Name
________________________________________________________
Department Chairman’s Signature
Date
The following must be attached to the application for submission to the CME Review Committee:
1. Signatures of both the course director and the departmental chairman must be on the application form.
2. Attach a reference list or copy of the first page of the last three journal articles.
3. Completed faculty disclosure forms of the course director(s) and other departmental members responsible for the educational
activity content with course director’s signature.
4. Activity evaluation form(s) to be used (Note: the required information stated under the evaluation policy).
Please send completed form and attachments to:
Genevieve Napier
Director, Office of Continuing Medical Education
Northwestern University, Feinberg School of Medicine
420 East Superior
Arthur J. Rubloff Building
6th Floor, Suite 680
Chicago, IL 60611-3008
Phone: 312-503-8536
Fax: 312-503-4531
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Faculty Disclosure Form – Page 1
Name:
Activity Title:
Date of Activity
Part 1: To be completed by the course director, committee member, speaker, etc.
“Relevant financial relationships” are those in which an individual (including spouse/domestic partner) has both:
1.
A personal financial relationship (any amount) with a commercial interest producing health care goods/services in the past 12
months (whether relationship has now ended or is currently active.)
2. Control in planning or presenting educational content addressing specific products/agents/devices of the commercial interest
(not simply a whole class of products or content about the whole disease class)
Disclosure: Regarding your role in the CME activity listed above, have you (or your spouse/partner) had a relevant personal financial relationship in the last 12 months
with the manufacturer of the products or services that will be discussed in the CME activity or in your presentation?
 No
Skip to OFF-LABEL DISCUSSION and DECLARATION sections below
 Yes
Please list your disclosures:
Nature of Relevant Financial Relationship
(include all those that apply)
Commercial Interest
Example: Company X
Type of Personal Financial Relationship. Stating what
was your role and what was received?
Relationship Status
Ended or Current?
Role: Speaker. Received: Honoraria
Role: Advisory Board Member: Received: Consultant Fee
Current
Additional information may be requested to resolve any conflict of interest. Disclosure will be made to the participants prior to the activity.
Please describe any additional information relevant to the disclosure below. How is your personal financial relationship related to the
educational content that you are presenting?
OFF-LABEL DISCUSSION:
I will be discussing a product which is still investigational or not labeled for the use under discussion. Please explain:
DECLARATION:
1. All the recommendations involving clinical medicine in a CME activity are based on evidence that is accepted within the profession of medicine as
adequate justification for their indications and contraindication in the care of patients.
2. All scientific research referred to, reported or used in CME in support or justification of a patient care recommendation must conform to the generally
accepted standards of experimental design, data collection and analysis.
3. I will uphold academic standards to insure balance, independence, objectivity and scientific rigor.
4. I agree to comply with the requirements to protect health information under the Health Insurance Portability and Accountability Act of 1996 (HIPPAA).
5. I agree to obtain the necessary copyright permission(s) if any portion of my CME activity materials that I prepare is not my original work or for which I
do not hold the copyright.
6. I understand that my CME presentation may be peer-reviewed for fair balance and validation of content and will be evaluated by participants for fair
balance.
Signature:__________________________________________________
Date: _________________________
Part 2: Must be completed by the Course Director if speaker indicated a current financial relationship
Conflict of Interest
Circumstances create a conflict of interest are when an individual has an opportunity to affect CME content about products or services of a commercial interest with which
he/she has a financial relationship. The act of disclosing to the participants, in itself, does not resolve the conflict of interest. Please see the attached page for approved
ways to resolve conflict of interests. Please indicate how you will resolve this conflict of interest and explain why this is an appropriate method.
As the course director, I propose the following to resolve the conflict of interest:
As the course director, I attest that the speaker’s disclosure information was communicated on the promotional flyer or verbally during the speaker’s introduction.
Signature:__________________________________________________
Updated 11/22/11
Date: _________________________
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Faculty Disclosure Form – Page 2
Resolving Conflict of Interest
Conflicts of interest may be resolved by:
1. Altering financial relationships – Individuals may change their relationships with commercial interests
(e.g., discontinue contracted services). Thereby eliminating any bias into the CME content.
2.
Choosing someone else to control that part of the content. If a proposed presenter or planner has a
conflict of interest related to the content, someone else who does not have a relationship to the
commercial interests related to the content may present or plan this part of the content.
3.
Change the focus of the CME activity so that the content is not about products or services of the
commercial interest that is the basis of the conflict of interest.
4.
Change the content of the person’s assignment so that it is no longer about products or services of the
commercial interest. For example, an individual with a conflict of interest regarding products for
treatment of a condition could address the pathophysiology or diagnosis of the condition, rather than
therapeutics.
5.
Limit the content to a report without recommendations. If an individual has been funded by a
commercial company to perform research, the individual’s presentation may be limited to the data and
results of the research. Someone else can be assigned to address broader implications and
recommendations.
6.
Limit the sources for recommendations. Rather than having a person with a conflict of interest present
personal recommendations or personally select the evidence to be presented, limit the role of the
person to reporting recommendations based on formal structured reviews of the literature with the
inclusion and exclusion criteria (‘evidence-based’).
7.
Independent Content Validation – Conflict of interest may be resolved if the CME material is peer
reviewed and:
 All recommendations involving clinical medicine are based on evidence that is accepted
within the profession of medicine as adequate justification for indications and
contraindications in the care of patients.
 All scientific research referred to, reported or used in the CME activity in support or
justification of patient care recommendations conforms to the generally accepted standards of
experimental design, data collection and analysis.
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