Conflicts of Interest (COI) Organization-Specific
Policies Refresher Module Terms and Conditions
As a part of the CITI Program’s COI Refresher course, your organization has the option of creating an
Organization-Specific Policies Refresher module. If you wish to setup this optional module for your
organization’s learners, please fill out and submit this form to citisupport@med.miami.edu.
If your organization already has an Organization/Institution-Specific Basic module and prefers to use it
for the COI Refresher course, then you do not need to fill out this form. For more information about this
option or to setup an organization-specific module for the COI Basic course, please contact
citisupport@med.miami.edu.
Submission Criteria
Information about your organizational policies must be submitted to CITI in a finalized form. The information
should be thoroughly reviewed by your organization prior to submission. Your organization is responsible for
the accuracy of the information sent. The CITI Program will only accept content that is presented in a
(.doc, .rtf, or .docx) format. Formats that cannot be accepted include:
a. PDFs, handwritten, scanned, or faxed materials
b. Documents that include notes, comments, strikethroughs, or any other type of editorial feedback
If you wish to display images, videos, graphs, charts, and/or case studies, please make sure to include the
intended location within the module and the presentation style (for example, hyperlink, image within module,
etc.) for each supplemental learning material. It is your organization’s responsibility to ensure that all
supplemental learning materials and hyperlinks within the module remain active and updated.
How To Submit Your Completed Content
All organization-specific content must be sent to citisupport@med.miami.edu as a finalized document. A case
number will be sent to you to confirm the receipt of your content. Please retain this case number.
Expected Completion Timeframe
Upon receiving your form, your request will be placed in the CITI Program support queue for the next
available technician to set up.
The technician will work to process your request in an expedient manner. If your organization-specific module
is greater than 5,000 words or has multiple supplemental learning tools, this may require a longer time to
upload the content. To check the status of your request, contact the Help Desk at (305) 243-7970 or
citisupport@med.miami.edu (please have your case number available).
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Approval Policy
Once the setup is complete, a Help Desk Technician will contact your organization’s delegated administrator
(the person listed on the last page of this form) for final approval.
Before the module is available to your learners, the delegated administrator must provide written consent via
email within seven (7) business days. Additional instructions on approval will be provided at that time.
During this time, it is the responsibility of the organization to review the module’s content for accuracy.
The CITI Program is not responsible for the accuracy of the content provided to create the
organization-specific module. Please note: Only your delegated administrator can approve your
organization-specific module before it goes live.
Updates to the Organization-Specific Module
As with all other customized modules, your organization is responsible for notifying the CITI Program about
any changes to the module’s content, including updates to links. The delegated administrator within your
organization should, at a minimum, review the module annually and notify the CITI Program accordingly.
Fees
All requests to add or modify the Organization-Specific Policies Refresher module will be subject to our
custom module programming fee(s) of $100/per hour. The Help Desk will provide you with a free estimate
prior to commencing work.
Organizations must be a CITI Program subscriber to access the COI Refresher course. Organizations with an
existing subscription may add the other COI Refresher modules to their curriculum for no additional cost.
Acceptance
I agree to all terms and conditions [ ]
___________________________________________________________
Please Print Name Above to Indicate Approval
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Module Set-Up Information
Name of Organization
Organization Name
Please Provide Your Contact Information
Name
Phone
Email
Will you be responsible
for reviewing and
updating the information
in the OrganizationSpecific Refresher
module?
Yes:
No: (If “no,” please provide name and contact of person responsible for ongoing
updates.)
Name:
Phone:
Email:
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Module Content Information
The Organization-Specific Policies Refresher module is intended to retrain learners on information related to
your organization’s COI policies. Learners may already be familiar with this information if your organization
utilized the Organization/Institution-Specific Basic module option for the CITI Program’s COI Basic course,
or if they read it in some other capacity.
It is recommended that simplified and concise content is presented in this module. For example, it may be a
shorter, summarized treatment of the Organization/Institution-Specific Basic module.
Part 1
Introduction
Introduce your organizational policies. This section might, for example, contain a statement from a senior
official at your organization.
Provide your introductory paragraph text below:
Learning Objectives
It is important to provide measurable learning objectives that represent the focus of the Organization-Specific
Policies Refresher module. The learning objectives should incorporate strong action verbs. For example:
By the end of this module, you should be able to:

Discuss the regulatory definitions associated with financial conflicts of interest (FCOIs) as defined by
the 2011 Final Rule (revised PHS regulations)
 Describe the organization’s policies related to COIs
 Identify the individuals responsible for the COI program at your organization
Provide your learning objectives below:
Please use a separate row for each objective. Space for three (3) learning objectives has been provided;
however, additional objectives may be included.
Learning Objective 1:
Learning Objective 2:
Learning Objective 3:
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Part 2
Organizational Policies and Procedures
This section is intended to provide general statements regarding your organizational policies and procedures,
definitions of key terms, and a list of links to your organization’s COI policies and procedures. You should
encourage your learners to visit your organization’s COI website(s) directly via the links to your policies and
procedures. URLs should be provided as a list at the end of the section, but you may reference the URLs
within the body of the narrative. When you provide the URL, please put the name of the page, as you would
like it to appear in the section.
Provide the general statements regarding your organizational policies and procedures below:
Definitions
If your organization created definitions of key terms, including any that vary from the ones provided by NIH,
please insert your definitions in the space that follows.
If relevant, you may want to include the following information within this section:



What is your organization’s definition of FCOI?
What is your organization’s definition of significant financial interest (SFI)?
What is your organization’s definition of “employee’s institutional responsibilities”?
If relevant, please provide your organization’s definitions below:
Title of
Web Page
Title of
Web Page
Title of
Web Page
Title of
Web Page
[Organization Name] Policies and Procedures
URL
URL
URL
URL
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Part 3
Investigator Disclosure Requirements
This section is intended to provide a review of the organizational policies and procedures associated with
investigator disclosure requirements. It should include information about what needs to be disclosed and how
the disclosure process should occur (for example, through an online system).
Provide the narrative related to your organization’s disclosure requirements below:
Part 4
Organization Assessment Responsibilities
This section is intended to provide a description of the process that the organization uses to assess/review
investigator SFIs. The CITI Program suggests the inclusion of information related to the following:
 How does your organization determine whether SFIs are related to research? (Describe the process.)
 How does your organization determine if the research-related SFIs create an FCOI?
 How does you organization address sub-recipient investigators?
Provide the narrative describing your organization’s assessment responsibilities and procedures below:
Organizational Management Plan for FCOIs
This section is intended to provide an overview of management plans, including as they relate to the 2011
Final Rule (revised PHS regulations). The CITI Program suggests including information about the following:
 What is a management plan?
 Who at your organization will develop the management plan?
 What are the required elements of your organization’s management plan?
 Who reviews and approves the FCOI management plans?
Provide the narrative describing management plans at your organization below:
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Part 5
Organizational Reporting Requirements
Organizations must report FCOIs of their employees to the NIH via the eRA Commons FCOI Module. This
section is intended for your organization to describe this process. Annual reporting is required as well as
reporting during the period of award within sixty (60) days of identifying a new FCOI.
Describe the elements that at minimum will be reported to the PHS/NIH. It is recommended that
bullets be used to list the items that will be reported.
FCOI Disclosure (Public Accessibility)
FCOIs of senior/key personnel discovered during the assessment process must be either displayed on the
organization’s website or made available by a written response to any requestor within five (5) business days
of a request.
Describe the organization’s FCOI disclosure policy and procedures below:
Part 6
SFI/FCOIs Identified Post Disclosure (Retrospective Review)
The purpose of this section is to provide information related to the organization’s policy and procedures
related to SFI/FCOIs identified post disclosure. The CITI Program recommends inclusion of information
related to the following questions.
 How does your organization define “retrospective review”?
 Within what timeframe does the review need to occur?
 Who will conduct the retrospective review at your organization?
 What are the required elements of the retrospective review?
 What other elements might the retrospective review include?
Please provide the narrative related to the organization’s SFI/FCOI identified post disclosure
procedure, including retrospective review, below:
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Part 7
Additional Information
If needed, provide any additional information related to your organization’s COI policies for your learners. If
relevant, you may want to include any additional information about main differences between your
organization-specific policies and HHS policy.
Please provide the additional information below:
Part 8
Summary
This section is intended to provide concluding comments for your organization’s learners along with any
additional information. The CITI Program recommends the following:



A summary statement that provides an overview of the content presented in the module
Additional organizational links
Links to external sources (PHS, NIH, or other entities)
A statement directing learners to the quiz/assessment (if your organization elects to quiz/assess learners, see
the next section).
Provide the summary narrative below:
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Part 9
Quiz/Assessment
Does your organization want to quiz your investigators on the materials included in this module?
If Yes:
If No:

Nothing further is required in this
It is recommended that three (3) multiplesection. Note that the CITI Program
choice questions be provided.
will include an attestation notice (“I
o Four (4) potential responses for each
question, but only one correct answer. have reviewed this module and the
applicable institutional documents”)
o Feedback to the learner describing
that learners must check at the end of
why the correct answer is correct.
the module.
o Avoid negative constructions of
questions (for example using “except”
or double negatives).
o Questions should be answerable based
on the content in the module. It is not
advisable to quiz on information from
links/secondary pages.
Provide questions, answer choices, and feedback here (you may copy the rows for as many
questions as your organization would like to provide; indicate which answer option is correct):
Question Stem:
Answer Choice 1:
Answer Choice 2:
Answer Choice 3:
Answer Choice 4:
Feedback for learner:
Question Stem:
Answer Choice 1:
Answer Choice 2:
Answer Choice 3:
Answer Choice 4:
Feedback for learner:
Question Stem:
Answer Choice 1:
Answer Choice 2:
Answer Choice 3:
Answer Choice 4:
Feedback for learner:
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Part 10
Learner Group Set-Up Information
Delegated Administrator
Please provide the contact information of your delegated administrator. This is the person who
should be contacted to approve the final Organization-Specific Policies Refresher module.
Name of
Delegated
Administrator
Email Address
End of Form
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