dataformdualCE - University of Colorado Denver

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University of Colorado Denver, College of Nursing
Office of Lifelong Learning (OLL)
Disclosure Data Form (Biographical Data/Vested Interest/Disclosure Information) for
Educational Activities Offering both CME and CNE
Title of Activity:
Date of Activity:
Content of Activity:
Your role (check all that apply):
Planner
Faculty/Presenter/Content Specialist
Reviewer/Other
Your Name:
Degrees and Credentials (include basic preparation through highest degree held – Year/Degree Awarded/Institution with
city and state)/Major Area of Study):
Full Address (Home or Business):
Day Telephone:
Email Address:
Present Position (Title) and Employer:
Planners: Describe your familiarity with the target audience:
Faculty/Presenters: Describe your expertise in this topic:
Reviewer/Other: Describe role in Provider Unit:
Planner, Reviewer, Faculty and Content Specialist Conflict of Interest Statement
The University of Colorado Denver (UC Denver), School of Medicine is accredited by the Accreditation Council for
Continuing Medical Education (ACCME). The UC Denver College of Nursing is an approved provider of continuing
nursing education by the Colorado Nurses Association, an accredited approved by the American Nurses Credentialing
Center’s Commission on Accreditation. As such, we have made the choice to meet the ACCME, CNA, and ANCC’s
expectations for our practice of continuing medical and nursing education. Our accreditation/providership is important to
us. We look forward to working together to provide CME/CNE of the highest standard.
Both the UC Denver’s School of Medicine and College of Nursing have implemented a process where everyone who is
in a position to control the content of an education activity has disclosed to us all relevant relationships (financial or
otherwise) with any commercial interest. Having an interest in an organization does not prevent a speaker from making a
presentation, but the audience must be informed of this relationship prior to the start of the activity. In addition, should it
be determined that a conflict of interest exists as a result of a relationship you may have, this will need to be resolved prior
to the activity. This information is necessary in order for us to be able to move to the next steps in planning this CME/CNE
activity.
In order to ensure balance, independence, objectivity and scientific rigor at all programs, the planners and faculty must
make full disclosure indicating whether the planner, faculty, or content specialist and/or his/her immediate family (includes
spouse) has any relationships with pharmaceutical companies, biomedical device manufacturers and/or corporations whose
products or services are related to pertinent therapeutic areas. All planners, faculty, content specialists and feedback
specialists participating in CE activities must disclose to the audience information listed below. If you refuse to disclose
relevant relationships, you will be disqualified from being a part of the planning and implementation of this CME/CNE
activity.
In the table that follows in Letter (A):
First, list the names of entities with which you or your spouse/partner or immediate family have, or have had, a relevant
financial relationship within the past 12 months. For this purpose we consider the relevant financial relationships of your spouse,
partner, or immediate family member that you are aware of to be yours.
Second, describe what you or your spouse/partner/immediate family member received (ex: salary, honorarium etc). The
University of Colorado Denver does NOT want to know how much you/they received.
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University of Colorado Denver, College of Nursing
Office of Lifelong Learning (OLL)
Third, describe your role within the company.
A. Is there a potential conflict of interest?
Yes [list company(ies) with relationship below]
No, I do not have any relevant financial relationships with any commercial interests.
Commercial Interest
Example: Company ‘X’
Nature of Relevant Financial Relationship/ What was
received (Include all those that apply)
Honorarium
Speakers Bureau
Grants/Research Support
Consultant
Stock Shareholder (directly purchased)
Employee:
Other:
Example terminology: What was received: Salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (e.g., stocks, stock
options or other ownership interest, excluding diversified mutual funds), or other financial benefit.
B. Discussion of off-label uses:
Yes
No
NA
If yes, you must disclose this information during your presentation. How will you do this?
Verbal statement during the presentation
Information provided on handouts
Information provided in audiovisuals (slides, overhead, PowerPoint, etc.)
Other -Describe:
C.
I have read and agree to the Terms and Conditions listed on the last page of this form
(If this box is not checked, you will be contacted by the CME/CNE office.)
All information disclosed will be shared with the audience either verbally, on program handouts, advertising and/or
audiovisual presentation.
Signature:
Date:
By checking this box, I am providing my electronic signature approving all the information entered above (if
choosing the electronic signature option please enter name and date on signature and date lines.)
*************************FOR OFFICE USE ONLY************************
How will any conflict of interest be resolved?
Discussed this conflict with the individual who is now aware of and agrees to our policy
Presenter has signed a statement that says s/he will present information fairly and without bias.
Nurse Planner or designee will monitor session to ensure conflict does not arise.
Not applicable since no conflict of interest.
Other: Describe:
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University of Colorado Denver, College of Nursing
Office of Lifelong Learning (OLL)
See Glossary of Terms on the last page of this document
Glossary of Terms
Commercial Interest:
The ACCME defines a “commercial interest” as any proprietary entity producing health care goods or services, used on, or consumed by,
patients, with the exemption of non-profit or government organizations and non-health care related companies.
The American Nurses Credentialing Center’s Commission on Accreditation (ANCC) defines an entity that has a “commercial interest” as
any proprietary entity producing health care goods or services, with the exception of non-profit or government organizations.
Financial relationships:
Financial relationships are those relationships in which the individual benefits by receiving a salary, royalty, intellectual property rights,
consulting fee, honoraria, ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds),
or other financial benefit. Financial benefits are usually associated with roles such as employment, management position, independent
contractor (including contracted research), consulting, speaking and teaching, membership on advisory committees or review panels,
board membership, and other activities from which remuneration is received, or expected. ACCME/ANCC considers relationships of the
person involved in the CME/CNE activity to include financial relationships of a spouse or partner or family member.
Relevant financial relationships:
ACCME focuses on financial relationships with commercial interests in the 12-month period preceding the time that the individual is
being asked to assume a role controlling content of the CME activity. ACCME has not set a minimal dollar amount for relationships to be
significant. Inherent in any amount is the incentive to maintain or increase the value of the relationship. The ACCME/ANCC defines
“’relevant’ financial relationships” as financial relationships in any amount occurring within the past 12 months that create a conflict of
interest.
Commercial Support:
The ANCC defines “commercial support” is defined as financial or in-kind contributions given by a commercial interest individual or
organization, which is used to pay all or part of the costs of a CNE activity.
Conflict of Interest: Circumstances create a conflict of interest when an individual has an opportunity to affect CME/CNE content
about/with products or services of a commercial interest with which he/she has a financial relationship.
Faculty Disclosure Terms and Conditions
The faculty member understands and accepts the following rules as required by the University of Colorado Denver (School of Medicine,
Office of Continuing Medical Education and College of Nursing, Office of Professional Development and Extended Studies) in
conformance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME), and the
rules of the Food and Drug Administration (FDA) and the American Medical Association (AMA).
Disclosure: Faculty members must complete and submit a Faculty Disclosure Data Form prior to the presentation, and that disclosure
form shall be complete and truthful to the best of the presenter's knowledge. Faculty members are required to disclose any relevant
financial relationship(s) involving themselves or their spouse/partner/family member within the last 12 months with any proprietary
entity producing health care goods or services (excluding non-profit or government organizations) related to the content of the activity.
Fair-Balance: Faculty members are required to prepare fair and balanced presentations that are objective and scientifically rigorous. The
presentation will be educational, not promotional, based on the stated objectives of the program and the identified educational needs of
the target audience. The presentation/participation is intended to promote improvements or quality in healthcare and in the public’s best
interest.
Unapproved Uses: Presentations that provide information whole or in part related to non-FDA approved uses for drug products and/or
devices must clearly acknowledge the unlabeled indications or the investigational nature of their proposed uses to the audience. Faculty
members who plan to discuss non-FDA approved uses for drug products and/or devices must advise the accredited provider of their
intent.
Use of Generic versus Trade Names: When applicable, presenters should use scientific or generic names when referring to products in
their lectures and discuss a balanced view of therapeutic options. Should it be necessary to use a trade name, the trade names of all
products should be used.
Commercial Supporter Influence: All support associated with a CME/CNE activity, whether in the form of an educational grant or not,
must be given with the full knowledge and approval of the accredited provider. No other funds from a commercial source shall be paid to
the director of the activity, faculty, or others involved with the supported activity. Presenters should not be subject to direct input from a
commercial supporter regarding the content of the presentation.
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