Centocor Ortho Biotech Inc - Janssen Therapeutics Educational Grants

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Tibotec Therapeutics, division of Centocor Ortho Biotech Services, L.P
Accredited Provider/Educational Partner Eligibility Survey
Please note: All organizations directly involved in certification or /and development of content for
independent medical education must review and sign the Certification of Separation section at the bottom of
this form
Is your organization an
Accredited Provider or
Educational Partner
Please note: Accredited Providers eligible to receive educational grant funding must be directly
involved in patient care (e.g., Academic Medical Center, Hospital, Medical Society, Professional
Society, etc.). If your organization (accredited or non-accredited) is not directly involved in
patient care (e.g., Medical Education Communications Companies), please partner with an
organization such as an Academic Medical Center, Hospital, Medical Society, Professional
Society, etc., when submitting a grant application.
Organization information
Legal Name
Company address
Company address 2
City
State
Primary Contact
Phone
Zipcode
Position/Title
Fax
email
Contact information for individual responsible for signing Educational Grant Agreements (EGA) if grant
request is approved for funding
Contact
Phone
Position/Title
Fax
email
Does your organization currently have expertise in HIV-related education?
Yes
No
Please provide details on the 3 most recent educational activities sponsored/developed in the area of HIV.
Activity Title
1
2
3
Revised 5/12/2009
Type of Activity
Select from list
Select from list
Select from list
Start date
Current Ownership Structure and Conflict of Interest Assessment
Which classification best describes your organization?
Non-government Academic Institution or Medical Center
Non-Academic Medical Institution (includes private and community hospitals)
For-Profit Public or Private Enterprise, including Medical Education Communication Companies
Federal Government (VA, DOD, Military)
Professional Society with IRS Tax Exempt Status (501c)
Organization with IRS Tax Exempt Status (501c3)
Non-profit Organization without IRS Tax Exempt Status
Non-US Based Organization
Other (describe)
Are there any prior or current relationships between Tibotec Therapeutics and key staff members or owners of
your organization?
Yes
No
If yes, please specify organizational size and associated ability to remove from participation in certified
independent educational activities any individuals with potential conflicts of interest
Does your company have a parent organization?
Yes
No
If yes, please provide the following parent organization information
Legal Name
Company address
Company address 2
City
State
Zipcode
Accredited Providers Only – Current Accreditation Status
Which regulatory bodies recognize your organization as an accredited provider or a designated approver of
certified independent education? Select all that apply and provide the expiration date and accreditation
duration
Name of Regulatory Body
Expiration date of current
accreditation/approval status
Length of term
Select from list
Select from list
Select from list
Select from list
Other:
For ACCME accredited providers, please provide the following information:
 Provide accreditation level (check one box)
accreditation
probation
accreditation with commendation
non-accreditation
provisional accreditation
Revised 5/12/2009
Within the previous 12 months, has your organization been asked to respond to a complaint or inquiry about
an educational activity? Yes
No
If yes, please describe the nature of the situation.
Within the previous 12 months, has your organization been placed on probation by an accrediting
organization?
Yes
No
If yes, please describe the nature of the situation.
Within the previous 12 months, has your organization been found to be in partial compliance or noncompliance by an accrediting organization? Yes
No
If yes, please describe the nature of the situation.
If there were findings of partial compliance or non-compliance did you receive any written communication
from the accrediting agency noting that the corrective action plan is acceptable?
Yes
No
If yes, please describe the nature of the situation.
Note: a copy of the communication may be requested prior to any reviews of grant submissions.
Accredited Providers Only – Compliance Readiness
Tibotec Therapeutics may require examples as a condition for providing educational grant funding
Please provide a summary of fair balance and commercial bias assessments/ratings for the last 3 educational
activities certified by your organization
Activity Title
Type of Activity
Method of
assessment
Summary
commercial
bias rating
Select from list
Select from list
Select from list
Does your organization have adequate staff to provide a detailed accounting and documentation of the
disbursement of grant funds, on a timely basis, if requested by the grantor?
Does your organization have a compliance officer?
If no, please explain.
Yes
No
Please identify whether your organization has developed written policies and procedures covering the
following specific risk areas:
Communications with grantors
Yes
No If no, please explain.
Interactions with faculty including fees, travel reimbursement policy, conflicts of interest, etc.
Yes
No If no, please explain.
Please identify whether your organization has the following compliance policies and processes in place:
Revised 5/12/2009
Adequate staff and documentation of ongoing education and training around compliance and CME and
other forms of outgoing communications for your staff
Yes
No If no, please explain.
A process for handling employee, attendee and accreditation agency complaints
A system/process to monitor and periodically assess your systems for compliance with grant
agreements with supporting commercial sponsors
Yes
No If no, please explain.
Written Procedures to manage corrective actions
Yes
No If no, please explain.
Written Policies describing disciplinary actions that can arise from breach of the compliance
requirements.
Yes
No If no, please explain.
CERTIFICATION OF SEPARATION
(Required for all Accredited Providers and Educational Partners)
(I)
I, Job Title, of Accredited Provider/Educational Partner, hereby certify that:
Accredited Provider/Educational Partner is not now, and has not been at any time during the last twelve
months, involved in providing or supporting advertising or other company-directed activities to Tibotec
Therapeutics, Division of Centocor Ortho Biotech Products, L.P. Company-directed activities include, but are
not limited to, advertising/promotional services, advisory boards/consultant meetings, promotional speaker’s
bureaus and publication planning.
OR
[If your company is part of a larger organization that owns another company (ies) that has handled commercial
or other company-directed activities for Tibotec Therapeutics, Division of Centocor Ortho Biotech Products, L.P
within the last 12 months]
(II)
I, Job Title, of Accredited Provider/Educational Partner, herby certify that:
Accredited Provider/Educational Partner is not now, and has not been in the past 12 months, involved in
providing advertising or other company directed activities or services to Tibotec Therapeutics, Division of
Centocor Ortho Biotech Products, L.P. in the same therapeutic area as proposed in the accompanying grant
application. Company-directed activities include, but are not limited to, advertising/promotional services,
advisory boards/consultant meetings planning, promotional speaker’s bureaus and publication planning.
Parent Company does not own a company that is or has been involved during the past 12 months in
commercial or other company directed activities for Tibotec Therapeutics, Division of Centocor Ortho Biotech
Products, L.P.
Accredited Provider/Educational Partner is a separate legal entity from Commercial Vendor, and has a
separate tax identification number from Commercial Vendor.
Revised 5/12/2009
Accredited Provider/Educational Partner does not share office space with Commercial Vendor.
The account management, editorial, sales, project planning personnel and medical advisors, both employees as
well as outside consultants, of Accredited Provider/Educational Partner are distinct and separate from the
account management, editorial, sales, project planning personnel and medical advisors of Commercial Vendor.
Accredited Provider/Educational Partner does not have access to records or computer systems impacting on
program content or project-related content maintained by Commercial Vendor.
Employees of Accredited Provider/Educational Partner do not and will not engage in communications with
employees of Promotional Vendor regarding Tibotec Therapeutics, Division of Centocor Ortho Biotech
Products, L.P. promotional strategies or company-directed activities.
Required Signatures
If any of the above information changes, I will notify Tibotec Therapeutics immediately.
Accredited Provider
Name, Title
(CE Compliance Officer/CE Director)
Signature
Revised 5/12/2009
Date
OR
Educational Partner
Name, Title
(President/CEO/CME Director)
Signature
Date
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