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TERUMO MEDICAL CORPORATION
SUBJECT: Research Grants and Funding of Investigator Initiated Sponsored Research
I.
PURPOSE:
The purpose of this document is to describe the procedures and policy followed by
Terumo Medical Corporation (TMC) as it pertains to research grants for Investigator
Initiated Sponsored Research (IISR).
II.
BACKGROUND:
Companies of medical products may choose to fund unsolicited external research
endeavors solely for the purpose of advancing science and/or clinical practice. This
is done via research grants for Investigator – Sponsored Studies (ISS). Decisions
for support are made independently of the commercial area of input.
III.
SCOPE:
This procedure applies to all grants of unsolicited external research funded by TMC.
This is open to qualified investigators from the United States (U.S.) and all countries
who wish to receive support for conduct of their own research. No grant may be
made to any individual or entity identified on, or associated with any organization or
known individual identified on, the Specially Designated National List of the U.S.
Treasury Dept.; the Department of Health and Human Services Office of Inspector
General's Exclusion Database; the FDA's debarment list; or the GSA list of
debarred persons.
Those investigators who plan to conduct investigational device exemption (IDE)
studies must submit the appropriate FDA application(s) and conduct the study per
the Code of Federal Regulations 812, respectively; TMC is not responsible for
writing, submitting, or conducting the IDE research study of interest
IV.
ROLES/RESPONSIBILITIES:
1.0
Sponsor or Investigator-Sponsor – The Sponsor, also referred to as the
Investigator-Sponsor in an Investigator-Sponsored Study, is responsible for
the conduct of the clinical trial or study. The Sponsor is also responsible and
liable for the initiation and limitation of the clinical investigation per FDA 21
CFR 812 and ISO 14155.
2.0
Grant Review Committee – The Grant Review Committee is responsible for
reviewing and approving any investigator proposal submitted to TMC and
any subsequent research grant provided for Investigator- Sponsored
research. The Committee evaluates the scientific merit and various aspects
of each proposal to ensure that all research funding is distributed and used
appropriately throughout the conduct of the trial. They are responsible for
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establishing procedures and selection criteria for determination of such
review and approval. The Grant Review Committee must maintain complete
files for all research grant requests, approvals, and activities.
3.0
V.
Director of Clinical Affairs – The Director of Clinical Affairs, or designee, is
responsible for the maintenance and oversight of the IISR program at TMC.
Such responsibility includes: research proposal submission and review,
website or paper submission management, facilitation of Grant Review
Committee’s review and evaluation of all proposals, facilitation of contracts,
tracking of study timelines and deliverables, and oversight of milestone
payments in accordance with the IISR contract.
DEFINITIONS:
See Investigational Study Procedure (CA004) for a list of definitions.
VI.
REFERENCES:
See Investigational Study Procedure (CA004) for a list of reference documents.
VII.
SAFETY:
No safety issues need to be addressed.
VIII.
PROCEDURES:
1.0
Summary
1.1
Mission
The mission of TMC is to support Investigator-Initiated or sponsored
research studies to advance medical and scientific knowledge which
may generate promising interventions.
1.2
Eligibility
Types of research that are eligible for support based on TMC’s
mission are as follows:
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1.3
Clinical studies of approved and unapproved uses, including
approved or unapproved TMC devices
Observational studies where the primary focus is the scientific
understanding of a disease
Other types of independent research on disease states where
TMC has professional interest
Types of Support Offered
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TMC may provide funding in the form of monetary support or any
combination thereof, as a research grant. TMC will provide a letter of
reference, submitted by an Investigator – Sponsor with an IDE
application that allows the FDA to reference proprietary information on
file with FDA. TMC will not disclose proprietary information, such as
manufacturing details, and device verification/validation testing,
directly to an Investigator – Sponsor.
(Note: Monetary or product donations may not be provided as a
substitute for a research grant. All research grants for investigator
initiated studies shall be administered in strict compliance with the
procedure set forth in this policy).
1.4
Research Grants
Offering of research grants should be limited to the support of bona
fide, commercially-reasonable and scientifically-warranted research
endeavors. These research grants do not pertain to grants to
organizations such as the American Heart Association or similar, but
rather, to individuals or institutions (such as hospitals), to fund specific
projects.
1.5
Research Grant Restrictions
1.5.1.1
All research grant applications, including the protocol and
budget, must be reviewed and approved by TMC’s Grant
Review Committee.
1.5.1.2
There must be no condition linking, either directly or
indirectly, the research funding with the research
institution’s purchase of products or services from TMC
(unless the purchase of products or service is for the
conduct of that research).
1.5.1.3
The research funding must be unrelated to past, present,
or future sales of TMC products or services to the research
institution or investigator.
1.5.1.4
The amount of the grant must be reasonable in the context
of the work to be performed within the research study and
must not exceed the proposed budget.
1.5.1.5
The purpose of the study must not be to educate a
physician or institution on the use of TMC products.
1.5.1.6
No grant may be made to any individual or institution/entity
identified on, or associated with, any organization or known
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individual identified on, the Specially Designated National
List of the U.S. Treasury Dept.; the Department of Health
and Human Services Office of Inspector General’s
Exclusion Database; the FDA’s debarment list; or the GSA
list of debarred persons.
1.5.1.6.1 No grant may be offered for support of ongoing clinical
programs that are part of an organization’s routine
operations.
1.5.1.6.2 No grant may be used as start-up funds to establish new
clinical or research programs or to expand existing
programs.
1.5.1.6.3 No grant may be used to purchase capital equipment
unrelated to the study or that would generate revenue.
1.5.1.6.4 No grant may be used for construction funds to build new
facilities.
1.5.1.6.5 No grant may be used for hiring staff that are not dedicated
to the study.
1.5.1.6.6 TMC cannot fund an IISR that will run in conjunction with a
TMC sponsored study.
1.6
Investigator – Sponsor Responsibilities
Unlike Terumo – Sponsored studies, investigator – initiated studies
are completely managed by an Investigator – Sponsor. The
Investigator-Sponsor will independently manage and perform all work
required for the study (i.e., concept and design, protocol, data
collection, conducting the statistical analysis and publishing the study).
TMC personnel must adhere to the following requirements to avoid
inadvertent qualification as the Study Sponsor:
1.6.1 TMC personnel may not approach an Investigator with a
request to conduct the study. However, TMC can engage in
discussions or publish its interest in funding specific categories
of research.
1.6.2 TMC personnel cannot write the protocol or pay to have it
written by a third party for the investigator.
1.6.3 TMC personnel may not provide the Sponsor-Investigator with
documents for use in the conduct of the study (i.e., protocol,
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informed consent form, etc), except those that relate to the
investigational device itself that are needed to obtain regulatory
(e.g., IDE) or IRB approval.
1.6.4 TMC personnel cannot advise the study site(s) on the conduct
of the study.
1.6.5 TMC personnel cannot require the Sponsor-Investigator to use
a particular vendor or service provider (e.g., Contract Research
Organization (CRO), etc.).
1.6.6 TMC personnel cannot provide functions that are typically
performed by a Sponsor, such as monitoring, build a database,
data management, report writing, auditing, etc.
1.6.7 TMC personnel may provide device training or in-servicing to
the Sponsor-Investigator and associated personnel.
1.6.8 TMC personnel may explain relevant regulatory requirements
to the Sponsor-Investigator.
1.7
Submission, Review, and Approval Process
1.7.1 Submission
1.7.1.1
Method
Research proposals can be submitted either as a
single page idea/concept or a fully developed
protocol. If an idea/concept is submitted and TMC is
interested in supporting the proposal, the Investigator
– Sponsor will be asked to submit a full proposal
including but not limited to a full protocol, detailed
budget and informed consent.
An investigator or institution may submit a research
grant proposal to TMC either through an established
TMC IISR website or, in the absence of website
availability, via paper. Either method should make
available proposal and budget forms by which the
investigator can complete all the necessary
information for the proposal’s consideration.
1.7.1.2
Single Page Concept
A request form for the research concept submission
(see Short form, Attachment 1) is completed by the
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Investigator – Sponsor. The purpose of the form is to
collect sufficient information about the proposed
study:
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1.7.1.3
Investigator name or Entity conducting study
Contact information
Amount requested
Study Concept, brief description of patient
population and method to measure
outcome(s)
The Curriculum Vitae of the Investigator –
Sponsor
Relevance to Terumo's products or the
rationale for funding if not relevant
Full Protocol Submission
A protocol is significantly more detailed and well
developed. The Investigator – Sponsor may initially
submit a full protocol proposal or upon notification
from Terumo that the concept merits submission of a
protocol (see Full Research Proposal form,
Attachment 3).
A complete protocol and comprehensive line item
study budget must be submitted. The study budget
must be inclusive of all costs, including any start – up
costs, salary support for all personnel, patient costs,
laboratory fees, monies for publications,
presentations, overhead, and associated travel and
any other requirements.
The following is required at the time of a full protocol
submission:
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A fully developed and well written protocol
describing the research in detail
The draft informed consent
The Curriculum Vitae of the principal
investigator and other key researchers
A copy of the IRB approval letter with the title
of the research proposal (if available and
required)
A detailed line item budget for the research
proposal
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1.7.1.4
Tracking
An appropriate tracking system for paper or
electronic records should allow:
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Submission and tracking of proposals
Forwarding of proposals to the appropriate
parties for review
Determination of whether all required
elements for a proposal are present before
accepting a submission
Logging of all proposals including approval
status (approved or declined)
1.7.2 Receipt, Proposal Preparation, Review and Approval
1.7.2.1
Receipt
TMC will acknowledge receipt of grant proposal
submissions by email to the submitter. Then
proposals should then be forwarded to the
appropriate TMC personnel for review.
1.7.2.2
Funding Availability
The Director of Clinical Affairs or designee will initiate
the RINGI process, put the request in the standard
format and circulate for approval among appropriate
parties to secure funding.
1.7.2.3
Grant Review Committee packet
After receipt of a research proposal a Grant Review
Committee packet is prepared by Clinical Affairs.
A Concept proposal packet includes:
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A completed concept proposal form
Updated and signed Sponsor-Investigator CV
Sponsor-Investigator debarment search
results
Documentation of funding availability
Any other study related materials (i.e. protocol
synopsis, etc), if available
A Full Research Proposal packet includes:
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A completed full research proposal form
Fully developed protocol and informed
consent (if applicable)
Line item budget
Institutional Review Board (IRB) approval (if
obtained)
Study timeline
Sponsor-Investigator debarment search
results
Documentation of funding availability
Any other study related materials (i.e., case
report forms, etc), if available
References (if applicable)
If a proposal is determined to meet the
submission requirements, Clinical Affairs will
forward to the Grant Review Committee for formal
presentation.
1.7.2.4
Composition of Grant Review Committee
The following cross-functional team members will be
responsible for review of the proposal:
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1.7.2.5
Director of Clinical Affairs
Director of Regulatory Affairs
Legal Representative
Vice-President (VP) of Human Resources
Corporate Compliance Officer
Grant Review Committee Meeting
Each request will be carefully reviewed for scientific
merit, alignment with TMC’s objectives,
appropriateness of the study design for the stated
objective, whether unnecessary patient risks are
involved, whether there is a risk of unsubstantiated
claims that could be made with the study data,
identifying possible operational risks in study
execution, fair market value, expertise of the
investigator, and whether the proposal adheres to
TMC’s IISR requirements.
The Grant Review Committee receives review
materials electronically. A face to face meeting or
teleconference may be held, if necessary.
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1.7.3 Approval Process
1.7.3.1
Approval
The proposal is considered approved if the majority
of members are in favor of approval. Upon approval,
the research approval form is completed, signatures
collected and filed in the study records.
1.7.3.2
Disproval
If the decision from the Grant Review Committee is
not to proceed, the Clinical Affairs Director shall
communicate the decision to the Investigator.
1.7.3.3
Timing
The Grant Review Committee process evaluation
period is approximately 4 weeks.
1.8
Award and Compensation
1.8.1 Conditions of Approval
If the TMC Grant Review Committee has reviewed the study
proposal packet and approves of the study, the following
conditions must still be met for the study to be conducted:
1.9

The investigator and/or investigator’s institution (if
applicable) and TMC agree to the conditions under an
Investigator-Sponsored research contract.

Regulatory bodies and Institutional Review Board (IRB), as
applicable, approve the investigator’s protocol and informed
consent.
Notification of Approval
Upon approval of the proposal by the Grant Review Committee, the
Director of Clinical Affairs or designee will inform the
Investigator/Institution in writing that the approval has been granted
and a IISR contract will be sent to initiate the process.
1.10
Financial Management and Study Oversight
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1.10.1 Clinical Study Agreements and Financial Disclosure
1.10.1.1 For all approved IISR research grants, the Director of
Clinical Affairs or designee should request financial
disclosures from the Investigator including their W-9
form and tax identification numbers.
1.10.1.2 The Director of Clinical Affairs or designee will send
the IISR agreement template with applicable study
milestones, projected study target dates, budget and
payment schedule to the Investigator for review. A
typical milestone and payout schedule is as follows:
 Contract execution (10% study budget)
 IRB approval (10% study budget)
 First subject enrolled (15% study budget)
 50% subjects enrolled (15% study budget)
 Last subject enrolled (15% study budget)
 Follow up complete (10% study budget)
 Final publication or Final report (25% budget)
1.10.1.3 If the investigator – sponsor or Institution proposes
any changes to the contract template, the altered
agreement must be reviewed by TMC’s legal
representative.
1.10.1.4 Once the agreement wording is finalized, two original
copies of the agreement are generated for signature
by the Investigator – Sponsor.
1.10.1.5 Once the signed agreement is received back from
the Investigator, the agreement is routed to the
Division President for signature.
1.10.1.6 Once the fully executed agreement is completed, one
contract original is sent to the Investigator with their
first milestone payment (according to the payment
schedule in the contract) and the other is maintained
in the Clinical Affairs files.
1.10.2 Study Payments
1.10.2.1 TMC requires the Investigator – Sponsor to submit a
payment request via an invoice per the payment
schedule contained in the IISR agreement. It is the
responsibility of the Director of Clinical Affairs or
designee to ensure study milestones and target
dates are met and appropriately documented.
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1.10.2.2 Investigators will be held to the deliverables and
timelines outlined in the contract. TMC is not
obligated to continue a study that is not meeting
contractually held deliverables and milestones.
1.11
Maintenance and Updates
1.11.1.1 Throughout the IISR study, the Director of Clinical
Affairs or designee will obtain updates from the
Investigator to track study progress against the
agreed milestones in the agreement. TMC requires
at least one study status update every quarter.
Updates are expected to contain information on
enrollment (if applicable), projected publications, and
study completion dates. TMC also requires
notification of any amendments to the original
protocol after the study has commenced.
1.11.2 Study Closure, Clinical Trial Data, and Publications
1.11.2.1 At the conclusion of the study, TMC expects to have
a publication result from the research, which can be
in the form of an abstract, a peer – reviewed journal
publication or a scientific society meeting
presentation. The Investigator – Sponsor will comply
with recognized ethical standards concerning
publications and authorship including the Uniform
Requirements for Manuscripts Submitted to
Biomedical Journals, www.icmje.org, established by
the International Committee of Medical Journal
Editors.
1.11.2.2 To ensure the ability to publish study results, the
Investigator – Sponsor must register the clinical trial
protocol information onto www.clinicaltrials.gov. prior
to enrolling the first patient.
1.11.2.3 In cases when a manuscript is not developed, then
the complete study report must contain, at minimum,
a description of the following details:
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Introduction
Rationale for the study
Study Objectives
Study Design
Study Endpoints (primary and secondary)
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Study Population
Treatments Administered and Assignment to
groups (if applicable)
Study Procedures/Methods (including
disposition of subjects)
Efficacy and Safety Variables
Statistical Methods
Disposition of patients and protocol deviations
Results (including adverse events and
complications)
Safety Evaluations
Discussion and overall conclusion
Tables, figures, graphs, references and
appendices as appropriate
1.11.2.4 TMC has the right to review any IISR presentation or
publication material according to the InvestigatorSponsored Study Agreement but no formal company
review is required. Any publication or presentation
material related to the IISR study shall be informally
reviewed by the Director of Clinical Affairs, at a
minimum.
1.11.2.5 Generally, the timeframe for obtaining a final
deliverable (publication or report) should be within 6
to 9 months after study completion.
1.11.2.6 Upon study closure, the investigator will be required
to certify that the study was conducted and the TMC
grant was used solely to conduct or report the study
and that all safety reporting obligations were met.
1.12
Records
1.12.1 Any documents pertaining to IISR protocol submission, review,
management, publication, investigator communications, etc.,
shall be saved and secured in Clinical Affairs.
IX.
SPECIAL INSTRUCTIONS:
This procedure does not apply to funding of continuing medical education or bona
fide charitable missions.
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X.
FLOW CHART
CA24: PROCESS FLOW CHART
INVESTIGATOR-SPONSOR
CA ASSOCIATE
DIRECTOR OF CA
TMC REVIEW COMMITTEE
START
Study Proposal
Short vs. Full
Form
NO
Short Form
Part A (K5906)
Submission
Complete
YES
5 Business Days
to Review
YES
Questions
NO
Short Form
Part B
(K5907)
Full Form
(K5904)
NO
Submission
Complete
YES
Prepare Packet
for GRC
Proposal
Review
YES
Questions
NO
Notify
InvestigatorSponsor
END
Research
Agreement
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Study Conduct
Study Completion
Data Analysis
Publication
Study Closure
Final Payment
Notify
InvestigatorSponsor
Proposal
Denied
Decision
Proposal
Approved
Tracking/
Payments
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