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 signthe 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., whensubmitting a grant application.
Organization information
Legal Name
Company address
Company address 2
CityStateZipcode
Primary ContactPosition/Title
PhoneFax email
Contact information for individual responsible for signing Educational Grant Agreements (EGA)if grant request is approved for funding
ContactPosition/Title
PhoneFax 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 / Type of Activity / Start date1 / Select from listPI/QI InitiativeGrand RoundsMultiple Educational OfferingOnline Educational MaterialsPrinted Materials/MonographPublicationsRecorded Program (CD/DVD)Seminar/SymposiaTeleconference/telecastOther
2 / Select from listPI/QI InitiativeGrand RoundsMultiple Educational OfferingOnline Educational MaterialsPrinted Materials/MonographPublicationsRecorded Program (CD/DVD)Seminar/SymposiaTeleconference/telecastOther
3 / Select from listPI/QI InitiativeGrand RoundsMultiple Educational OfferingOnline Educational MaterialsPrinted Materials/MonographPublicationsRecorded Program (CD/DVD)Seminar/SymposiaTeleconference/telecastOther
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 Therapeuticsand 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
CityStateZipcode
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 termSelect from listACCMEACPECMSAANCCAAFPAOAAANPACOGNAPNAPASWBAPA (Psychologists)other
Select from listACCMEACPECMSAANCCAAFPAOAAANPACOGNAPNAPASWBAPA (Psychologists)other
Select from listACCMEACPECMSAANCCAAFPAOAAANPACOGNAPNAPASWBAPA (Psychologists)other
Select from listACCMEACPECMSAANCCAAFPAOAAANPACOGNAPNAPASWBAPA (Psychologists)other
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
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 non-compliance 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 ratingSelect from listPI/QI InitiativeGrand RoundsMultiple Educational OfferingOnline Educational MaterialsPrinted Materials/MonographPublicationsRecorded Program (CD/DVD)Seminar/SymposiaTeleconference/telecastOther
Select from listPI/QI InitiativeGrand RoundsMultiple Educational OfferingOnline Educational MaterialsPrinted Materials/MonographPublicationsRecorded Program (CD/DVD)Seminar/SymposiaTeleconference/telecastOther
Select from listPI/QI InitiativeGrand RoundsMultiple Educational OfferingOnline Educational MaterialsPrinted Materials/MonographPublicationsRecorded Program (CD/DVD)Seminar/SymposiaTeleconference/telecastOther
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? YesNo
If no, please explain.
Please identify whether your organization has developed written policies and procedures covering the following specific risk areas:
Communications with grantors
YesNo If no, please explain.
Interactions with faculty including fees, travel reimbursement policy, conflicts of interest, etc.
YesNo If no, please explain.
Please identify whether your organization has the following compliance policies and processes in place:
Adequate staff and documentation of ongoing education and training around compliance and CME and other forms of outgoing communications for your staff
YesNo 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
YesNo If no, please explain.
Written Procedures to manage corrective actions
YesNo If no, please explain.
Written Policies describing disciplinary actions that can arise from breach of the compliance requirements.
YesNo 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 Partneris 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 Companydoes 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 fromCommercial Vendor, and has a separate tax identification number from Commercial Vendor.
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 Partnerdoes not have access to records or computer systems impacting on program content or project-related content maintained byCommercial 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 / OR / Educational PartnerName, Title / Name, Title
(CE Compliance Officer/CE Director) / (President/CEO/CME Director)
Signature Date / Signature Date
Revised 5/12/2009