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MOC Secon 3 Simulaon (SIM) Applicaon Form Jan 2020 1 | Page Accreditaon Applicaon Form Secon 3 Simulaon (SIM) Maintenance of Cerficaon (MOC) Royal College of Physicians and Surgeons of Canada Simulaon acvies are designed to reflect real life situaons to enable parcipants to demonstrate and receive feedback on their clinical reasoning, communicaon, situaonal awareness, problem solving and (where applicable) their ability to col- laborate and work effecvely within a healthcare team. Simulaon acvies reflect a range of opons including role playing, use of standardized paents, task trainers, virtual simulaon, hapc simulaon, theatre simulaon or hybrids of any of these examples. Important informaon before you begin: Simulaon Acvies approved under Secon 3 must be developed or co-developed by a physician organizaon, please visit our website or contact the Royal Collage to confirm before subming an applicaon. A physician organizaon is defined by the Royal College as a not-for-profit group of health professionals with a formal governance structure, accountable to and serving, among others, its specialist physician members through: connuing professional development, provision of health care, and/or research. Addional consideraons: MOC Secon 3 – Assessment accredited Simulaon Acvies are approved for a maximum of three years from the start date of the acvity. Accreditaon will not be granted retroacvely. The organizaon that developed the acvity is responsible for maintaining all records (including aendance records) for a 5-year period. Applicaon steps: Refer to the Royal College CPD Accredited Acvity Standards for Simulaon Acvies (Secon 3) as you com- plete this applicaon and prepare the aachments. A summary of the review will be emailed to the physician organizaon including the outcome of the assess- ment of the CPD acvity, the number of accredited hours, and the CPD acvity accreditaon statement that must appear on all accredited CPD acvity program materials and cerficates of parcipaon. Has a needs assessment been completed? Aach a summary of the completed needs assessment. Have you aached the overall and session specific learning objecves? Does the preliminary and final program or brochure include: o The acvity schedule, topics, and start and end mes of individual sessions? o The acvity learning objecves for the overall acvity and individual sessions (if applicable) Have you aached any other materials that will be used to promote or adverse the acvity (for example, invita- ons, email announcements, etc.?) (if applicable) Have you aached the sponsorship and/or exhibitor prospectus developed to solicit sponsors/exhibitors for the acvity? (if applicable) If sponsorship has been received for this acvity, have you aached the wrien agreement that is signed by the CPD provider organizaon and the sponsor? Does the acvity budget show receipt and expenditure of all sources of revenue for this acvity including: o A list of funding sources, including an indicaon of whether sponsorship was received in an educaonal grant or in-kind support? Before you submit your applicaon - have you completed and aached the following:

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Page 1: Accreditation Application Form Section 3 Simulation (SIM ... · MOC Section 3 Simulation (SIM) Application Form Jan 2020 2 | Page o A list of expenditures? o The expected number of

MOC Section 3 Simulation (SIM) Application Form Jan 2020 1 | Page

Accreditation Application FormSection 3 Simulation (SIM) Maintenance of Certification (MOC)

Royal College of Physicians and Surgeons of Canada

Simulation activities are designed to reflect real life situations to enable participants to demonstrate and receive feedback on their clinical reasoning, communication, situational awareness, problem solving and (where applicable) their ability to col-laborate and work effectively within a healthcare team. Simulation activities reflect a range of options including role playing, use of standardized patients, task trainers, virtual simulation, haptic simulation, theatre simulation or hybrids of any of these examples.

Important information before you begin:• Simulation Activities approved under Section 3 must be developed or co-developed by a physician organization,

please visit our website or contact the Royal Collage to confirm before submitting an application.

A physician organization is defined by the Royal College as a not-for-profit group of health professionals with a formal governance structure, accountable to and serving, among others, its specialist physician members through: continuing professional development, provision of health care, and/or research.

Additional considerations:• MOC Section 3 – Assessment accredited Simulation Activities are approved for a maximum of three years from

the start date of the activity.• Accreditation will not be granted retroactively.• The organization that developed the activity is responsible for maintaining all records (including attendance

records) for a 5-year period.

Application steps:• Refer to the Royal College CPD Accredited Activity Standards for Simulation Activities (Section 3) as you com-

plete this application and prepare the attachments.• A summary of the review will be emailed to the physician organization including the outcome of the assess-

ment of the CPD activity, the number of accredited hours, and the CPD activity accreditation statement that must appear on all accredited CPD activity program materials and certificates of participation.

Has a needs assessment been completed? Attach a summary of the completed needs assessment.Have you attached the overall and session specific learning objectives?Does the preliminary and final program or brochure include:

o The activity schedule, topics, and start and end times of individual sessions?o The activity learning objectives for the overall activity and individual sessions (if applicable)

Have you attached any other materials that will be used to promote or advertise the activity (for example, invita-tions, email announcements, etc.?) (if applicable)Have you attached the sponsorship and/or exhibitor prospectus developed to solicit sponsors/exhibitors for the activity? (if applicable)If sponsorship has been received for this activity, have you attached the written agreement that is signed by the CPD provider organization and the sponsor?Does the activity budget show receipt and expenditure of all sources of revenue for this activity including:

o A list of funding sources, including an indication of whether sponsorship was received in an educational grant or in-kind support?

Before you submit your application - have you completed and attached the following:

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o A list of expenditures?o The expected number of registrants?

Have you attached the template for the certificate of attendance that will be provided to the participants? Remember that the physician organization must maintain attendance records for five years.Do the evaluation and feedback forms include:

o A question on whether the stated learning objectives were met?o A question for participants to identify the potential impact to their practice?o A question for participants to identify if the session was balanced and free from commercial or other

inappropriate bias?o A question on which CanMEDS Roles were addressed during the activity?

Have you attached a sample conflict of interest form and an outline of the process for the collection, manage-ment, and disclosure of conflicts of interests which includes a description of how this information is collected and disclosed to participants? Required regardless of how the activity is funded.Have you attached a copy of the answer sheet or assessment tool that allows participants to demonstrate knowledge, skills, clinical judgement or attitudes?Has the Chair of the scientific planning committee attested that he/she agrees with the content provided in the application package? – see Section D

The Royal College has created a CPD toolkit to help developers of educational activities who want to create quality programs. Each topic in the toolkit includes explanations, practical examples and other resources. http://www.royal-college.ca/rcsite/cpd/accreditation/cpd-activity-toolkit-e

• Needs Assessment • Learning Objectives• Educational Delivery Methods• Evaluations• Web-based CPD Activities• Relationships with speakers and sponsors• Sample Conflict of Interest Form• Sample Certificate of Attendance

Activity Information

1. Date of Application

2. Simulation Activity Title:

3. Event Start/End Date:

4. Delivery Method of Simulation Activity:

Web-based Face-to-face Both web-based and face-to-face

5. How many times will this activity be held? 1 2 3 4

6. Estimated # of participants:

7. Has the activity been previously accredited? YES NO

8. If yes, when was it reviewed?

9. If yes, by which CPD accreditation system?

10. What is the maximum number of hours required to complete the simulation activity?

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1. Name and contact informa-tion for physician organization requesting accreditation:

Name of physician organization:Address:Email: Telephone #:Website Address:

2. Contact information for main point-of-contact

First Name:Last Name:Address:Email:Telephone #:

3. Name and contact informa-tion for Scientific Planning Committee Chair: (If different form above)

First Name:Last Name:Address:Email:Telephone #:

4. Name and contact informa-tion for organization co-de-veloping the activity – only applicable if activity was co-developed

Name of Organization:Address:Email:Telephone #:

Part A: Administrative Standards

Name of physician organization that developed the simulation activity

5. Is the developing organization a physician organization? YES NO

6. Will the physician organization maintain attendance records for 5 years? YES NO

7. Was the content developed by the applying physician organization? YES NO

If no, who developed the content?

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8. Scientific Planning Committee members (SPC)Complete the table below. Include it as an attachment if you have this information already available electronically.

Name of SPC Member How does the individual represent target audience? Is the individual a member of the

physician organization responsible for

planning the CPD activity?

Part B: Educational Standards

1. What is the intended target audience of the simulation activity?

2. What needs assessment strategies were used to identify the learning needs (perceived and/or unperceived) of the target audience?

3. What learning needs or gap(s) in knowledge, attitudes, skills or performance of the intended target audience did the scientific planning committee identify for this activity?

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4. How were the identified needs of the target audience used to develop the learning objectives for the simulation activity

For example:• Did the scientific planning committee share the needs assessment results with the individual(s) who are

responsible for developing the learning objectives?• Did the scientific planning committee used the needs assessment results to define the learning objectives

for the activity?

5. CanMEDS Role(s) relevant to this activity? Check all that apply

Medical Expert Leader Health Advocate Scholar Communicator Collaborator Professional

6. What opportunity do learners have to identify and evaluate the CanMEDS Role(s)?

7. Describe the key knowledge areas of themes assessed by this simulation activity

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8. State the sources of information selected by the planning committee to develop the content of this activity. e.g. scientific literature, clinical practice guidelines, etc.

9. What simulation methods were selected to enable participants to demonstrate their abilities, skills, clinical judge-ment or attitudes?

10. How will learners participate in the simulation?

11. How will learners provide responses to on-line simulation? e.g. through an online response sheet or web based assessment tools. Attach a copy of the answer sheet or assessment

tool.

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12. How will learners receive feedback after the completion of an online simulation?

13. How will learners received feedback (debrief) after the completion of a live simulation? Attach a copy of the an-swer sheet if applicable.

14. How will feedback (debrief) be provided to learners on their performance to enable the identification of any areas requiring improvement through the development of a future learning plan?

15. How will the simulation activity be evaluated by the learners?

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16. (Optional) If the program evaluation strategy intends to measure changes in knowledge, skills or attitudes of learn-ers, please describe:

17. (Optional) If the program evaluation strategy intends to measure improved health care outcomes, please describe.

Part C: Ethical Standards

All accredited activities after January 1, 2018 must comply with the National Standard for support of Accredited CPD Activities. The national Standard applies to all situations where financial and in-kind support is accepted to contribute to the development, delivery and/or evaluation of accredited CPD activities.

1. Has the CPD activity been sponsored by one or more sponsors? YES NO

2. If yes, have the terms, conditions and purposes by which sponsorship is provided been documented in a written agreement that is signed by the CPD provider organization and that sponsor? Attach a sample.

3. If sponsorship or funding has been received, please check all sources that apply.

Government Agency Health Care Facility Not-for-profit organization

Medical Device Company Pharmaceutical Company Education or CommunicationCompany

Other please specify

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4. If yes, please list the name of the sponsor(s) below and indicate whether the sponsor provided financial or in-kind support (should you require more space, attach a new page).

Sponsor Name Type of SupportFinancial support

Amount received or antici-pated to receive:

In-kind support

Amount received or antici-pated to receive:

For-profit sponsor

or

Non-profit sponsor

Financial support

Amount received or antici-pated to receive:

In-kind support

Amount received or antici-pated to receive:

For-profit sponsor

or

Non-profit sponsor

Financial support

Amount received or antici-pated to receive:

In-kind support

Amount received or antici-pated to receive:

For-profit sponsor

or

Non-profit sponsor

Financial support

Amount received or antici-pated to receive:

In-kind support

Amount received or antici-pated to receive:

For-profit sponsor

or

Non-profit sponsor

5. Please describe how sponsorship funds will be used including whom is responsible for paying the speaker and scientific planning committee honoraria, travel and out of pocket expenses (as applicable).

6. Please describe the process by which the SPC maintained control over the CPD program elements including:• the identification of the educational needs of the intended target audience; development of learning objectives• selection of educational methods; selection of speakers, moderators, facilitators and authors;• development and delivery of content; and evaluation of outcomes

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7. Please describe the process used to develop content for this activity that is scientifically valid, objective, and bal-anced across relevant therapeutic options.

8. How were those responsible for developing or delivering content informed that any description of therapeutic options must utilize generic names (or both generic and trade names) and not reflect exclusivity and branding?

9. All accredited CPD activities must comply with the National Standard for support of accredited CPD activities. If the scientific planning committee identifies that the content of the CPD activity does not comply with the ethical standards, what process would be followed? How would the issue be managed?

10. How are the scientific planning committee members’ conflicts of interest declarations collected and disclosed to:• The physician organization?• To the learners attending the CPD activity?

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11. How are the speakers’, authors’, moderators’, facilitators’ and/or authors’ conflicts of interest information collected and disclosed to:• The scientific planning committee?• To the learners attending the CPD activity?

12. If a conflict of interest is identified, what are the scientific planning committee’s methods to manage potential of real conflicts of interests?

13. How are payments of travel, lodging, out-of-pocket expenses, and honoraria made to members of the scientific planning committee, speakers, moderators, facilitators and/or authors?

If the responsibility for these payments is delegated to a third party, please describe how the CPD provider organization or SPC retains overall accountability for these payments.

14. How has the physician organization ensured that their interactions with sponsors have met professional and legal standards including the protection of privacy, confidentiality, copyright and contractual law regulations?

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15. How has the physician organization ensured that product specific advertising, promotional materials or other branding strategies have not been included on, appear within, or be adjacent to any educational materials, activity agendas, programs or calendars of events, and/or any webpages or electronic media containing educational

material?

16. What arrangements were used to separate commercial exhibits or advertisements in a location that is clearly and completely separated from the accredited CPD activity?

17. If incentives were provided to participants associated with an accredited CPD activity, how were these incentives reviewed and approved by the physician organization?

18. What strategies were used by the scientific planning committee or the physician organization to prevent the sched-uling of unaccredited CPD activities occurring at the time and locations where accredited activities were sched-uled?

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The preliminary program/brochure

The final program

Any other materials to promote or advertise the activity (for example, invitations, email announcements) (if applicable)

Sample form and process for the collection, management and disclosure of conflicts of interests.

The (summarized) needs assessment results

The template evaluation form(s) developed for this activity

The budget for this activity that details the receipt and expenditure of all sources of revenue

The template certificate of attendance that will be provided to participants

The sponsorship and/or exhibitor prospectus developed to solicit sponsorship/exhibitors for the activity(if applicable)

A copy of the answer sheet or assessment tool that allows participants to demonstrate knowledge, skills, clinical judgement or attitudes

If sponsorship has been received for this activity, attach the written agreement that is signed by the CPD provider organization and the sponsor

Attach the following documentation to the application form:

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Part D: Declaration

As the chair of the scientific planning committee (or equivalent), I accept the responsibility for the accuracy of the infor-mation provided in response to the questions listed on this application, and to the best of my knowledge, I certify that the CMA’s guidelines, entitled CMA Policy: Guildeines for Physicans in Interaction with Industry (2007) and National Standard for Support of Accredited CPD Activities have been met in preparing for this activity.

I agree By clicking “I Agree” you are agreeing to the declaration stated above

Name:

Date:(dd/mm/yyy)

Note: Applicants should keep a list of attendees for a period of five years.

This section is to be completed by the Accredited CPD Provider and returned to the program planner.

(The Accredited CPD Provider should keep a copy of the completed application form.)

This application is:

Approved Requires Revisions Prior to Approval Denied Revisions Approved

Name of assessor:

On behalf of the Division of Continuing Medical Education, University of Saskatchewan

Date of Review:

Approved by the Accreditation Director and Associate Dean, CME

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Part E: CPD Accreditation Agreements

The Royal College has several international CPD accreditation agreements. These agreements allow physicians and/or oth-er health professionals to claim or convert select Royal College MOC credits to other CPD system credits. Details about the specific agreements are available on our website.

Should you wish for this CPD activity to be eligible for credit within any of these systems, please check all that apply:

American Medical Association (AMA) PRA Cateogry 1 CreditTM

European Union of Medical Specialists (UEMS)

Qatar Council for Healthcare Practitioners (QCHP)

European Board for Accreditation in Cardiology (EBAC)

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Declaring & Disclosing of Conflict of InterestRoyal College of Physicians and Surgeons of Canada (RCPSC) (MOC credits):

The Royal College of Physicians and Surgeons of Canada requires all presenters and members of Planning Committees to complete this Disclosure of Conflict of Interest form. The 2007 CMA Guidelines for Physicians in Interaction with Industry, Section 24, states that,

• “CME/CPD organizers and individual physician presenters are responsible for ensuring the scientific validity,objectivity and completeness of CME/CPD activities. Organizers and individual presenters must disclose to theparticipants at their CME/CPD events any financial affiliations with manufacturers of products mentioned atthe event or with manufacturers of competing products.”

The College of Family Physicians of Canada (CFPC) (Mainpro+ credits):

The College of Family Physicians of Canada (CFPC) requires compliance with the National Standard for Support of Ac-credited CPD Activities (the National Standard), which describes the process and requirements for gathering, manag-ing, and disclosing conflicts of interest (COI) to participants.

Definitions:

A COI may occur in situations where the personal and professional interests of individuals may have actual, potential or apparent influence over their judgment and actions. The intent of this disclosure requirement is to inform the audience of any bias that speakers may have, not to prohibit speakers from presenting.

National Standard Element 3: Conflict of Interest

3.1 All members of the scientific planning committee (SPC), speakers, moderators, facilitators and authors must provide to the CME/CPD provider organization a written description of all relationships with for-profit and not-for-profit orga-nizations over the previous two (2) years including (but not necessarily limited to):

• Any direct financial payments including receipt of honoraria;• Membership on advisory boards or speakers’ bureaus;• Funded grants or clinical trials;• Patents on a drug, product or device; and• All other investments or relationships that could be seen by a reasonable, well informed participant as having

the potential to influence the content of the educational activity.Failure to disclose, or false disclosure, may require the Scientific Planning Committee to replace the speaker. If you have any questions regarding conflict of interest disclosure when preparing your CME/CPD presentations, please con-tact your CME/CPD provider or Scientific Planning Committee.

Complete, sign and return your COI form as soon as possible for review.Return form to: [email protected]

SAM

PLE

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Disclosure of Conflict of I terestSpeaker, moderator, facilitator, and author forms: Completed forms must be submitted to the scientific planning com-mittee of the CME/CPD provider. It is the role of the Scientific Planning Committee to review all disclosed financial re-lationships of speakers, moderators, facilitators and authors in advance of the CME/CPD activity to determine whether action is required to manage potential, perceived, or real COIs.

Speakers, moderators, facilitators, and authors must ensure their presentations, and any recommendations, are bal-anced and reflect the current scientific literature. Unapproved use of products or services must be declared within the presentation. The only caveat to this guideline is where there is only one treatment or management strategy.

How to disclose:

Complete the attached disclosure form and submit to the CME/CPD Provider or Planner prior to the start date of the event or program.

• Part 1 – must be completed by all Speakers, Scientific Planning Committee, Moderators, Facilitators andAuthors.

• Part 2 – must be completed by all Speakers, Moderators, Facilitators and Authors.

• Part 3 – must indicate whether you are a Scientific Planning Committee member, Speaker, Moderator, Fa-cilitator and/or Author.

RCPSC and CFPC require both verbal and visual (slide) disclosure at the beginning of every presentation and/or introduc-tion. Speakers who have no involvement with industry should inform the audience that they cannot identify any conflict of interest and include this declaration in their slides and/or written material. If a disclosure slide has not been included in a presentation, it must be inserted by the Planning Committee.

Example of speaker disclosure slide – to be included in speaker presentation (sample slide provided):

Faculty / Speaker

Faculty: [NAME]

Relationship with financial spons s:

• Grants/Research Support: [LIST ANY/ALL/NONE]

• Speakers Bureau/Honoraria: [LIST ANY/ALL/NONE]

• Consulting Fees: [LIST ANY/ALL/NONE]

• Patents: [LIST ANY/ALL/NONE]

• Other: [LIST ANY/ALL/NONE]

Should you have nothing to make public, you need to type “Nothing to declare.”

“Other” would include: “I am a paid employee of _____.”

SAM

PLE

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Disclosure of Conflict of I terest Form – page 1Part 1 – completed by Scientific Planning Comm ee, Speakers, Moderators, Facilitators and Authors.

I do not have an affiliation (financial or otherwise) with any for-profit (pharmaceutical, medical device and/or communications firm) and/or not-for-profit organization(s).

I have/had an affiliation (financial or otherwise) with a for-profit (pharmaceutical, medical device and/or communications firm) and/or not-for-profit organization(s).

Complete the sections below that apply to you now or during the past two (2) years up to and including the current year. Information includes relationships with for-profit and not-for-profit organizations.

Planning Commi� ee, Speakers, Moderators, Facilitators,

Authors, Other

For-Profit or No -for-Profit O ganization(s Description of elationshi

AAny direct financial relationships including receipt of honoraria, gifts, in-kind compensation, etc.

BMembership on advisory boards or speakers’ bureaus

CFunded grants, research and/or clinical trials

DPatents for drug(s) and/or device(s) referred to in the CME/CPD program

EAny direct financial relationships that have funded this program

F

All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity (pharmaceutical, medical device, communications firm)

Part 2 – completed by Speakers, Moderators, Facilitators and Authors. Check Yes or No.

I intend to make therapeutic recommendations for medications that have not received regulatory approval (i.e., off-label use of medications). Yes No

You must declare all off-label use to the audience during your presentation.

I acknowledge that the National Standard requires that any descriptions of therapeutic options use generic names (or both generic and trade names) and do not reflect exclusivity and branding. If no generic name exists, trade names must be used in a consistent manner.

Yes NoFailure to do this is a violation of the National Standard and the RCPSC and CFPC require-ments.

SAM

PLE

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Disclosure of Conflict of I terest Form – page 2

Part 3 - Identi� atio

Check all that apply:

Scientific Planning Committee Speaker

Moderator Facilitator

Author Other:

Event Informatio

Name of Program/EventDate of Program/EventTitle of Presentation (if applicable)

Full Name (to appear on schedule)

Professional Title (to appear on schedule)

Acknowledgement

I, ____________________________________, acknowledge that I have reviewed the declaration form’s guidelines and instructions, and deem all of my information above accurate. I understand that the CME/CPD provider and the Scientific Planning Committee for this program/activity will review all disclosed financial (or otherwise) relationships and determine whether action is required to manage potential, perceived, or real COIs. I also understand that this information will be publicly available.

Signature: _____________________________________________________

Date: _________________________________________________________

Please return signed disclosure form (pages 1 & 2) to: [email protected]

SAM

PLE

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SAMPLE