enduring materials - UCSD Continuing Medical Education

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UC San Diego/ACCME Requirements & Guidelines for
ENDURING & INTERNET MATERIALS
Revised 04/17/11
**All content must be reviewed by the CME office prior to delivery to learners.
Please allow a minimum of 5 business days for review.**
The definition of Enduring Materials is as follows:
An enduring material is a non-live CME activity that "endures" over time. The learning experience by the physician
can take place at any time in any place, rather than only at one time, and one place, like a live CME activity.
Examples of such materials for independent physician learning include: Programmed texts, audio-tapes, videotapes
and computer assisted instructional materials (CD-ROMS, DVDs & programs) which are used alone or in
combination with written materials. An enduring material is most typically a DVD, monograph, CD-Rom or
podcast. Enduring materials can also be delivered via the Internet. Books, journals (unless specifically designated)
and manuals are not classified as enduring materials.
The following applies to any enduring material requesting CME:
There are specific communication requirements for enduring materials because of the nature of the activities. For
CME activities including those in which the learner participates electronically (e.g. via Internet, CD-ROM, satellite
broadcasts), there is no direct interaction between the faculty and the learner, hence all required UCSD/ACCME
information must be transmitted/communicated to the learner prior to the learner beginning the CME activity.
Checklist 
DONE REQUIREMENT
Activity Title (required)
Logo (required)
Sponsor Listed (required)
Course Description (required)
Target Audience (required)
Objectives (required)
COMMENTS
Please list prominently.
The UC San Diego School of Medicine Logo is required on the front of
all materials and must be displayed prominently. If needed, request from
CME office.
The University of California, San Diego School of Medicine must be
listed as the accrediting sponsor. Please seek assistance from CME if
joint sponsor.
List a description which tells the potential participants what you would
like them to know about your program, e.g. highlight topic areas.
List the identified types of health professionals specifically targeted (i.e.,
primary care physicians, cardiologists, neurologists, etc.) for this activity.
Learning objectives should be clearly stated , must be measureable and
written from the perspective of what you expect the learner to do in the
practice setting with the information you are teaching. It is helpful to
formulate the objectives by starting with:
At the conclusion of this activity, the participants should be able to:
Needs Assessment with practice
gap (required)
List the needs assessment for the activity including a paragraph
summarizing the practice gaps.
A Needs Assessment defines the need for the activity and assesses the
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gap in terms of knowledge, skills and behavior between “What is”
(actual patient care) and “What should be” (optimal patient care). Or in
other words, it is the difference between what is occurring in practice and
what is expected (the desired outcome), or, the difference between what
is and what should be.
The identified needs are the basis for content, format and evaluation. The
needs identification process sets the stage for the development of the
learning objectives (what the participants can expect to get out of the
activity) which is then followed by format selection (the best method to
deliver content and teach those objectives).
There are 2 types of ACCME accreditation statements, direct or joint.
Direct is used if UC San Diego directly sponsors the activity. The jointly
sponsored statement is used if UC San Diego and another organization
are jointly sponsoring the activity.
Accreditation Statement
(required)
Credit Designation Statement
(required)
Direct:
The University of California, San Diego School of Medicine is
accredited by the Accreditation Council for Continuing Medical
Education to provide continuing medical education for physicians.
Joint:
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 the University of
California, San Diego School of Medicine and (Joint Sponsor). The
University of California, San Diego School of Medicine is accredited by
the ACCME to provide continuing medical education for physicians.
AMA credit designation statement:
The University of California, San Diego School of Medicine designates
this enduring material for a maximum of [number of credits] AMA PRA
Category 1 Credit(s)™. Physicians should claim only the credit
commensurate with the extent of their participation in the activity.
Notes: AMA PRA Category 1 Credit™ must be italicized. The number of
credits will be included in your approval letter.
Other specialty credit designation statements may also be listed.
This is a California state requirement regardless of location of activity.
The subject of Cultural and Linguistic competency should be
incorporated in to your activity. The statement below is required:
Cultural and Linguistic
Competency Statement
(required)
Principal faculty and their
credentials (required)
Disclosure Statement
(required)
This activity is in compliance with California Assembly Bill 1195 which
requires continuing medical education activities with patient care
components to include curriculum in the subjects of cultural and
linguistic competency. Cultural competency is defined as a set of
integrated attitudes, knowledge, and skills that enables health care
professionals or organizations to care effectively for patients from
diverse cultures, groups, and communities. Linguistic competency is
defined as the ability of a physician or surgeon to provide patients who
do not speak English or who have limited ability to speak English, direct
communication in the patient’s primary language. Cultural and linguistic
competency was incorporated into the planning of this activity.
Additional resources on cultural and linguistic competency and
information about AB1195 can be found on the UCSD CME website at
http://cme.ucsd.edu.
List full name, degree, and organizational affiliation for all faculty
(speakers, panel members, authors, etc) and denote course director.
The statement below is required:
It is the policy of the University of California, San Diego School of
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Disclosure summary (required)
Medium or combination of
media used (required)
Method of physician
participation in the learning
process (required)
Estimated time to complete the
educational activity (required)
Dates of original release, most
recent review or update, and
termination date (required)
Commercial Support
Acknowledgement
Registration Information
Institutional Acknowledgement
Advertising
Medicine to ensure balance, independence, objectivity and scientific
rigor. All persons involved in the selection, development and
presentation of content are required to disclose any real or apparent
conflicts of interest. All conflicts of interest will be resolved prior to an
educational activity being delivered to learners through one of the
following mechanisms 1) altering the financial relationship with the
commercial interest, 2) altering the individual’s control over CME
content about the products or services of the commercial interest, and/or
3) validating the activity content through independent peer review. All
persons are also required to disclose any discussions of off
label/unapproved uses of drugs or devices. Persons who refuse or fail to
disclose are disqualified from participating in the CME activity.
This is a summary of all disclosures that were collected and should be
placed after faculty list. Please see example.
Hardware/Software requirements. At the start of an Internet CME
activity, the hardware and software required must be indicated for the
learner to participate.
Instructions will vary depending on activity format, but should stipulate
that participants:
 Review the materials on accreditation information, target audience,
learning objectives, and disclosure information
 Complete the entire self-study activity
 Complete the self-assessment and evaluation/claim form
The number of hours it should take to complete will be the same as
number of designated credits.
The Release Date is the date you plan to release the activity, the first day
it will be available to participants. Termination Date or End Date is the
date after which the enduring material is no longer certified for credit enduring materials are required to be reviewed at least once annually for
up to 3 years, or more frequently if indicated by new scientific
developments.
List all commercial supporter(s) for the activity.
Commercial support must be acknowledged in order to comply with the
ACCME Standards for Commercial Support and references to a
company or institution are allowed. This acknowledgement must be
placed only at the beginning of the enduring material.
Note: Fully executed LOAs on file with UCSD CME are required in
order to acknowledge the commercial supporters.
Instructions for registration. Add a form or link for potential participants
to register for the activity.
The institutional acknowledgement may state the name, mission, and
areas of clinical involvement of the company or institution and may
include corporate logos and slogans, if they are not product promotional
in nature.
Product specific advertising of any type is prohibited in enduring
materials. No specific products may be referenced, even if they are not
related to the topic of the enduring material.
**Examples listed on pages 5-10**
ADDITIONAL INTERNET CME GUIDELINES
Live or enduring material activities that are provided via the Internet are considered to be “Internet CME.”. There
are specific requirements for Internet CME because of the nature of the activities:
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1. CME activities delivered via the Internet are expected to be in compliance with ACCME Essential Areas,
Elements, and Policies.
2. Activity Location: There shall be no CME activities on a pharmaceutical or device manufacturers’ product
website.
3. Links to Product Websites: With clear notification that the learner is leaving the
Educational website, links from the website of a CME accredited activity to pharmaceutical and device
manufacturers’ product website are permitted before or after the educational content of a CME activity, but
shall not be embedded in the educational content of a CME activity.
4. Advertising: Advertising of any type is prohibited within the educational Content of CME activities on the
Internet including, but not limited to, banner ads, subliminal ads, and pop-up window ads. For computer
based CME activities, advertisements and promotional materials may not be visible on the screen at the
same time as the CME content and not interleafed between computer ‘windows’ or screens of the CME
content.
5. Hardware/Software Requirements: The hardware and software required must be indicated at the start of an
Internet CME activity for the learner to participate.
6. Provider Contact Information: A mechanism must be in place for the learner to be able to contact the
accredited provider if there are Questions about the Internet CME activity.
7. Policy on Privacy and Confidentiality: The accredited provider must have, adhere to and inform the learner
about its policy on privacy and confidentiality that relates to the CME activities it provides on the internet.
8. Copyright: The accredited provider must be able to document that it owns the copyright for, or has received
permission for use of, or is other wise permitted to use copyrighted materials within a CME activity on the
Internet.
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EXAMPLES
Logo (required)
Course Description (required)
Example…
Patients with obstructive sleep apnea may present significant problems in the perioperative period, including difficult airways,
sensitivity to anesthetic agents, and postoperative adverse events. This eight page monograph is an assimilation of material
presented at the Challenges in the Perioperative Management of OSA Patients symposium, held in October of 2010, and is
designed to provide practical solutions and strategies for the perioperative care of patients with OSA. Additional contributions
have been made by course faculty, and references to recent publications regarding OSA practice guidelines have been included.
Target Audience (required)
Example…
This activity is designed for anesthesiologists, surgeons, physicians, nurse practitioners, certified nurse anesthetists, anesthesia
assistants, respiratory therapists, and other healthcare providers interested in the perioperative care of patients with obstructive
sleep apnea.
Objectives (required)
Example…
Following completion of this educational activity, learners should be able to:




Review the pathophysiology of OSA in the context of recent clinical research regarding perioperative care, sleep, and
anesthesia.
Determine the challenging link between comorbidities, including obesity, and their effects on airway management and
ventilation.
Formulate how to implement screening and treatment procedures for obstructive sleep apnea.
Discuss the preoperative, intraoperative, and postoperative risks to patients with OSA, and apply strategies to mitigate
these risks in support of positive patient outcomes.
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Needs Assessment with Practice Gap (required)
Example…
Upper airway patency is essential for normal respiratory function. The maintenance of a patent airway is dependent primarily
on the pharyngeal structures. However in some individuals, there is a loss of this airway patency and obstruction occurs during
sleep. This interruption of airflow is due to the collapse of pharyngeal soft tissue. Obstructive sleep apnea (OSA) is caused by
repetitive partial or complete obstruction of the upper airway, characterized by episodes of breathing cessation during sleep,
which lasts 10 or more seconds. This airway obstruction in turn causes increase in sympathetic output and tone, repetitive
arousals from sleep to restore airway patency, which may result in daytime hypersomnolence, memory loss, other
psychological disturbances, and an increase in inflammatory mediators. OSA has known associations with several
comorbidities. These consist of cardiovascular disease including acute myocardial infarction, heart failure, arrhythmias,
hypertension, cerebrovascular disease, metabolic syndrome, obesity, and the attendant risk of gastro-oesophageal reflux and
pulmonary aspiration. Untreated OSA is associated with an increase in morbidity and mortality.
OSA is the most prevalent breathing disturbance during sleep. From estimations in the general population, a high proportion
(24% men, 9% women) have an apnea hypopnea index of 5 or greater, and moderately severe OSA was present in 11.4% of
men and 4.7% of women. It has been estimated that 90% of the patients with OSA in the general population are undiagnosed.
Similarly, a significant proportion of these patients are undiagnosed prior to surgery. Severe OSA is a syndrome associated
with hypoxaemia, hypercarbia, polycythaemia, cor pulmonale, and hypertension. From the standpoint of the anesthesiologist,
there are concerns with difficult airways, and patient sensitivity to sedatives and analgesic medications. OSA has also been
associated with an increase in postoperative complications. Therefore, OSA is increasingly being recognized as a significant
perioperative concern. It is important for anesthesiologists, surgeons and physicians to have up-to-date knowledge about the
perioperative management of the patients with obstructive sleep apnea in order to improve their performance and care of this
patient population.
This educational program will attempt to provide clinicians with “best practice” advice and practical solutions and is designed
for anesthesiologists, surgeons, and physicians interested in the perioperative care of patients with obstructive sleep apnea.
Other healthcare professionals who may benefit from this activity are nurses, certified nurse anesthetists and nurse
practitioners, anesthesia assistants, respiratory therapists, hospital administrators, and anesthesia fellows or residents.
Accreditation Statement and Credit Designation Statement (required)
For all jointly sponsored activities, please use the following statement. The appropriate accreditation statement will also
be included in your approval letter.
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 the University of California, San Diego School of
Medicine and (Joint Sponsor). The University of California, San Diego School of Medicine is accredited by the ACCME to
provide continuing medical education for physicians.
The University of California, San Diego School of Medicine designates this enduring material for a maximum of [number of
credits] AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their
participation in the activity.
Faculty List (required)
Co-Directors
Frances Chung, MBBS
Professor, Department of Anesthesia
Medical Director, Combined Surgical Unit
and Ambulatory Surgical Unit
University Health Network
University of Toronto
Toronto, Ontario, Canada
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Terence M. Davidson, MD
Professor of Surgery, Head and Neck Surgery
University of California, San Diego School of Medicine
San Diego, California, USA
Faculty
Jonathan L. Benumof, MD
Professor
Department of Anesthesiology
University of California, San Diego
San Diego, California, USA
Daniel Davis, MD
Professor of Clinical Medicine
Department of Emergency Medicine
University of California, San Diego
San Diego, California, USA
Thomas Ebert, MD
Professor and Program Director
Department of Anesthesiology
Medical College of Wisconsin
Staff Anesthesiologist
VA Medical Center
Milwaukee, Wisconsin, USA
David Hillman, MBBS, FANZCA, FRCP(Edin), FRACP(Hon)
Head, Department of Pulmonary Physiology
Director, West Australian Sleep Disorders Research Institute
Sir Charles Gairdner Hospital
Perth, Australia
Shiroh Isono, MD
Associate Professor, Department of Anesthesiology
Graduate School of Medicine
Chiba University
Chiba, Japan
Disclosure (required)
It is the policy of the University of California, San Diego School of Medicine to ensure balance, independence, objectivity and
scientific rigor. All persons involved in the selection, development and presentation of content are required to disclose any real
or apparent conflicts of interest. All conflicts of interest will be resolved prior to an educational activity being delivered to
learners through one of the following mechanisms 1) altering the financial relationship with the commercial interest, 2) altering
the individual’s control over CME content about the products or services of the commercial interest, and/or 3) validating the
activity content through independent peer review. All persons are also required to disclose any discussions of off
label/unapproved uses of drugs or devices. Persons who refuse or fail to disclose are disqualified from participating in the CME
activity. This information is used to plan future activities.
The faculty have reported the following relevant financial relationships:
Frances Chung, MBBS: Research grants from the ResMed Foundation and the Respironic Foundation
Terence Davidson, MD: Member of the ResMed Foundation Board.
David Hillman, MBBS: Consultant for ResMed
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The following faculty have no financial relationships other than listed above with commercial interests relevant to the content
of this activity.
Jonathan Benumof, MD
Daniel Davis, MD
Thomas Ebert, MD
Shiroh Isono, MD
The CME staff, meeting planners, editorial staff, planning committee, and CME committee reviewers other than listed above
do not have any relevant financial relationships to disclose.
Off-label Disclosure: This educational activity may contain discussion of unlabeled and/or investigational uses of agents that
are not approved by the FDA. Please consult the prescribing information for each product.
The views and opinions expressed in this activity are those of the faculty and do not necessarily reflect the views of the
University of California, San Diego.
Medium or combination of media used (required)
Example…
●
Monograph - This activity is a monograph based on an original clinical paper written by Dr. Weber, Glass
and Brouett.
●
CD-ROM - Interactive CD-ROM
●
DVD – DVD
●
Internet -
I. Overview
Follow these steps to determine if your computer has the system requirements to view the presentations.
A. Review Hardware Requirements - Please read Hardware Requirements, section II below, to be sure your
computer has the proper hardware to view the presentations. If your computer does not meet the minimum system
requirements, your system will perform slowly and will have a difficult time loading presentations and
navigating within them.
B. Review Software Requirements - This webcast is supported on computers running the Windows Operating
System and Macintosh operating system.
C. Mobile Device Users - mobile device users, view support information below.
II. Hardware Requirements
You must have the following hardware components in order to view presentations.
A. COMPUTER: Minimum processor and memory as recommended by operating system manufacturer.
B. INTERNET CONNECTION: A broadband Internet connection is required. Dial-up modem users can download
event audio in mp3 format from event page or the podcast feed.
C. SOUND: 16-bit sound card and speakers
D. DISPLAY: A VGA display set to a screen area of 1024 x 768 pixels or higher and 16 bits of color or higher.
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III. Software Requirements
Windows OS System Requirements
A. Versions supported: Windows XP, Vista, 7
B. Adobe Flash Player: The webcast requires version 10 or higher of Adobe Flash Player. Consult the table provided
at the URL below to determine the minimum web browser supported on each operating system version.
Check Operating System and Browser Version Support from Adobe
C. Web Browser support:
Microsoft Internet Explorer, or Firefox 3.x, Safari 4.x
Your web browser should have JavaScript enabled.
Macintosh System Requirements
The webcast requires version 10 or higher of Adobe Flash Player. Consult the table provided at the URL below to
determine the minimum web browser supported on each operating system version.
Check Operating System and Browser Version Support from Adobe
Your browser should have JavaScript enabled.
IV. Mobile Device Support
Users with the Apple iPad, iPhone, and iPod Touch with an enabled Internet connection can stream sessions to
their mobile device directly from the event page. Users of non-streaming enabled mobile devices may use the
podcast feed to download the session audio to their mobile device.
Method of physician participation in the learning process (required)
Example…
●
Monograph The estimated time to complete this activity is 1 hour. To obtain credit, participants should register for the
activity (link to registration/activity page), take the online pretest, read the monograph, answer the multiplechoice posttest questions, and complete the evaluation form online to receive a certificate online immediately
upon completion. Adobe Reader is required to view this monograph, and can be downloaded at
http://get.adobe.com/reader/.
●
CD-ROM This CME activity incorporates instructional design to enhance your retention of the didactic information and
pharmacological concepts that are presented. You are advised to go through this program from beginning to
end. You will first study the figures and listen to the accompanying narrations for each figure. After
completing, you will then go over the figures again. This will allow interaction with the materials and also
provide repeated exposure to the data and concepts presented both visually and orally. After you have gone
through the entire program, complete the Post Test. You must also complete the evaluation form and mail it
along with your Post Test.
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●
DVD Participants must score at least 70% on the post test to receive credit. Certificates will be mailed within 6
weeks of receipt to those who submit the Registration and Evaluation forms and successfully complete the
post test.
1. Fill out the Evaluation Form
2. Fill out the post test answer sheet and the Registration form.
3. Detach and mail the Evaluation form, Post Test answer sheet, and Registration from to the following
address.
Dates of original release, most recent review or update, and termination date (required)
Example…
●
Release Date: July 1, 2009
Expiration Date: June 30, 2011
-ORDate of Release/Date of Expiration
July 1, 2009 – June 30, 2011
Commercial Support Acknowledgement
Example…
This activity is supported by educational grants provided by Phillips Respironics and ResMed.
Medium or combination of media used (required)
Example…
●
Monograph - This activity is a monograph based on an original clinical paper written by Dr. Weber, Glass
and Brouett.
●
CD-ROM - Interactive CD-ROM
●
DVD – DVD
●
Internet - See example below
I. Overview
Follow these steps to determine if your computer has the system requirements to view the presentations.
A. Review Hardware Requirements - Please read Hardware Requirements, section II below, to be sure your
computer has the proper hardware to view the presentations. If your computer does not meet the minimum system
requirements, your system will perform slowly and will have a difficult time loading presentations and
navigating within them.
B. Review Software Requirements - This webcast is supported on computers running the Windows Operating
System and Macintosh operating system.
C. Mobile Device Users - mobile device users, view support information below.
11
II. Hardware Requirements
You must have the following hardware components in order to view presentations.
A. COMPUTER: Minimum processor and memory as recommended by operating system manufacturer.
B. INTERNET CONNECTION: A broadband Internet connection is required. Dial-up modem users can download
event audio in mp3 format from event page or the podcast feed.
C. SOUND: 16-bit sound card and speakers
D. DISPLAY: A VGA display set to a screen area of 1024 x 768 pixels or higher and 16 bits of color or higher.
III. Software Requirements
Windows OS System Requirements
A. Versions supported: Windows XP, Vista, 7
B. Adobe Flash Player: The webcast requires version 10 or higher of Adobe Flash Player. Consult the table provided
at the URL below to determine the minimum web browser supported on each operating system version.
Check Operating System and Browser Version Support from Adobe
C. Web Browser support:
Microsoft Internet Explorer, or Firefox 3.x, Safari 4.x
Your web browser should have JavaScript enabled.
Macintosh System Requirements
The webcast requires version 10 or higher of Adobe Flash Player. Consult the table provided at the URL below to
determine the minimum web browser supported on each operating system version.
Check Operating System and Browser Version Support from Adobe
Your browser should have JavaScript enabled.
IV. Mobile Device Support
Users with the Apple iPad, iPhone, and iPod Touch with an enabled Internet connection can stream sessions to
their mobile device directly from the event page. Users of non-streaming enabled mobile devices may use the
podcast feed to download the session audio to their mobile device.
Method of physician participation in the learning process (required)
Example…
●
Monograph - The estimated time to complete this activity is 1 hour. To obtain credit, participants should
register for the activity (link to registration/activity page), take the online pretest, read the monograph,
answer the multiple-choice posttest questions, and complete the evaluation form online to receive a
12
certificate online immediately upon completion. Adobe Reader is required to view this monograph, and can
be downloaded at http://get.adobe.com/reader/.
●
CD-ROM - This CME activity incorporates instructional design to enhance your retention of the didactic
information and pharmacological concepts that are presented. You are advised to go through this program
from beginning to end. You will first study the figures and listen to the accompanying narrations for each
figure. After completing, you will then go over the figures again. This will allow interaction with the
materials and also provide repeated exposure to the data and concepts presented both visually and orally.
After you have gone through the entire program, complete the Post Test. You must also complete the
evaluation form and mail it along with your Post Test.
●
DVD - Participants must score at least 70% on the post test to receive credit. Certificates will be mailed
within 6 weeks of receipt to those who submit the Registration and Evaluation forms and successfully
complete the post test.
1. Fill out the Evaluation Form
2. Fill out the post test answer sheet and the Registration form.
3. Detach and mail the Evaluation form, Post Test answer sheet, and Registration from to the following
address.
Dates of original release, most recent review or update, and termination date (required)
Example…
●
Release Date: July 1, 2009
Expiration Date: June 30, 2011
-ORDate of Release/Date of Expiration
July 1, 2009 – June 30, 2011
Commercial Support Acknowledgement
Example…
This activity is supported by educational grants provided by Phillips Respironics and ResMed.
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