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Dutch FAQ

FREQUENTLY ASKED QUESTIONS

What are the ASPIRE I-CRP awards?

The ASPIRE I-CRP aims to inspire and fund innovative research projects in the field of inflammation which may further enhance the understanding of certain conditions within the fields of rheumatology, dermatology and gastroenterology and contribute to excellence in patient care.

Pfizer is fully funding the Dutch I-CRP awards. Additionally, Pfizer is providing the infrastructure and administrative support required to facilitate the application process and the review process, as well as notifying applicants and distributing awards. All applications will be formally reviewed by an independent committee of European medical experts in the field of the specific area.

Due to FCPA regulations, submissions selected for awards by the review committee must go through an internal review at Pfizer to ensure provision of the grant is appropriate and relevant information regarding potentially influencing government official status, as well as beneficiaries and controllers information ,is captured (when applicable).
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Who is eligible to apply for ASPIRE I-CRP awards?

ASPIRE I-CRP award applications are possible for any investigator. To be eligible for an investigator award, applicants must have a professional degree (e.g. MD, PhD, PharmD), and must reside in the Netherlands.

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What is the role of Pfizer in the ASPIRE I-CRP awards?

Pfizer will provide the administrative support required to facilitate the application process and the review process, as well as notifying applicants and distributing awards. All applications will be formally reviewed by the review committee including European medical and scientific experts.
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How many ASPIRE I-CRP awards are available?

A total budget has been set for the ASPIRE I-CRP. Depending on the quality and budget of proposals, 3 awards will be granted.
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When will the ASPIRE I-CRP awards be announced?

The successful awardees will be notified about four months after the application deadline. See home page for key dates.
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Is the funding a per-annum or per-study amount?

Each award funds the entire research period, and is not a sum paid per year.
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Does the funding include Institutional overhead costs and indirect costs?

The maximum funding for each type of award may include indirect costs, and institutional overhead costs. Final budgets of those studies awarded a grant will be reviewed for fair market value before the contracting process begins.
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What are indirect costs?

Indirect costs are additional study expenses such as costs for publication and supplies.
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What are institutional overhead costs?

Institutional overhead costs, are costs to the institution for the support of your study. They are not easily identifiable in an economically feasible way as exclusively related to a particular project but are necessary to conduct the grant. Some examples of these costs are human resources department costs, payroll processing and accounting costs, janitorial services, utilities, property taxes, property and liability insurance, and building maintenance.
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How are the funds dispensed?

The awards will be paid based on milestones to be determined during the contracting process.
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How may the ASPIRE I-CRP funding be used?

Funds can be used to cover the awardees’ salary and fringe benefits, as well as other direct expenses incurred during the research project. Direct expenses may include the salary of technical associates; the purchase of relevant laboratory supplies; direct expenses necessary for proper conduct of research (e.g. subject-related costs, study-related personnel costs, diagnostic fees/services, data management expenses). Indirect costs may include travel expenses to scientific meetings, software licensing fees, publication costs etc.

No other government, non-governmental, or industry-sponsored projects may cover the same work scope as the grant application to the ASPIRE I-CRP Program. However, an ASPIRE I-CRP grant may be related to other funding from foundations or government agencies, as long as there is no direct overlap. It is the responsibility of the applicant to justify the novelty of the proposal and provide evidence that the application does not overlap with any current or pending funding.

Note also that, due to the competitive nature of these awards, Pfizer cannot provide any additional funding and/or drug support beyond what has been requested and approved by the external independent review panel.
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Can ASPIRE I-CRP funding be used to purchase equipment?

No, ASPIRE I-CRP funds may not be used to purchase equipment, although the purchase of relevant laboratory supplies is allowed.
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Are the ASPIRE I-CRP awards renewable?

No, each ASPIRE I-CRP award is a non-renewable research grant. Payments for each grant are made based on milestones, which will be determined during the contracting process.
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Are the ASPIRE I-CRP awards opened to researchers working outside the Netherlands?

No. The Dutch ASPIRE I-CRP awards are opened only to researchers in the Netherlands.


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What areas of research meet the criteria for ASPIRE I-CRP funding?

Research proposals with the objective of advancing medical knowledge in specific research area. See home page or visit www.europeaspire.org for specific areas of focus.
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Are there any specific research areas that are excluded from ASPIRE I-CRP funding?

The following topics fall outside of the scope of the ASPIRE Programme:

  • General education and / or training
  • Public health
  • Support for ongoing clinical programs that are part of an organization’s routine operations
  • Direct comparative treatment studies primarily involving competitor products
  • Studies where the risk/benefit ratio to patients is not obviously positive
  • Studies that involve the use of compounds in development
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What project deliverables are required?

Projects are expected to yield results that will advance the medical knowledge in specific research areas. It is expected that results will be presented at scientific meetings and published in peer reviewed journals.
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Will non-drug research proposals be considered?

Yes. Both drug and non-drug proposals will be considered for funding.
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If the study uses a Pfizer drug, what are Pfizer’s procedures for reporting of Serious Adverse Events?

For All Studies Using a Pfizer Product and/or Device: Reporting of Serious Adverse Events Within 24 hours of first awareness of the event (immediately if the event is fatal or life-threatening), Principal Investigator will report to Pfizer by facsimile any Serious Adverse Event (“SAE,” as defined below) for which reporting is required under this provision (as described below). Such SAEs are to be reported for (1) Study subjects who are assigned or, in the case of a blinded Study, possibly assigned to receive the Pfizer Product or (2) individuals otherwise exposed to the Pfizer Product as described below. Principal Investigator should report SAEs as soon as they are determined to meet the definition, even if complete information is not yet available.

  • Reporting Forms. Principal Investigator will report SAEs using one of the following forms: (1) a reporting form approved by the local regulatory authority, (2) a CIOMS form, (3) a Pfizer-provided Investigator-Initiated Research Serious Adverse Event Form, or (4) any other form prospectively approved by Pfizer. The Reportable Event Fax Cover Sheet provided by Pfizer must also be included with each SAE submitted.
  • SAE Definition. An SAE is any adverse event, without regard to causality, that is life-threatening (i.e., causes an immediate risk of death) or that results in any of the following outcomes: death; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity (ie, substantial disruption of the ability to conduct normal life functions); or a congenital anomaly or birth defect. Any other medical event that, in the medical judgment of the Principal Investigator, may jeopardize the subject or may require medical or surgical intervention to prevent one of the outcomes listed above is also considered an SAE. A planned medical or surgical procedure is not, in itself, an SAE.
  • Exposure During Pregnancy, Exposure During Lactation, Occupational Exposure, and Lack Of Effect. Even though there may not be an associated SAE, exposure to the Pfizer Product during pregnancy, exposure to the Pfizer Product during lactation, and occupational exposure to the Pfizer Product are reportable, and lack of effect of the Pfizer Product may also be reportable. These requirements are further explained in the training material provided by Pfizer (see Pfizer-Provided Training, below). As used in this Agreement, the term SAE will be understood to include exposure during pregnancy, exposure during lactation, occupational exposure, and reportable instances of lack of effect..
  • Hy’s Law Cases. Cases of potential drug-induced liver injury as assessed by laboratory test values (“Hy’s Law Cases”) are also reportable to Pfizer. If a Study subject develops abnormal values in aspartate transaminase (AST) or alanine transaminase or both, concurrent with abnormal elevations in total bilirubin and no other known cause of liver injury, that event would be classified as a Hy’s Law Case. This reporting requirement is further explained in the training material provided by Pfizer (see Pfizer-Provided Training, below). As used in this Agreement, the term SAE will be understood to also include Hy’s Law Cases.
  • Exclusions from SAE Reporting Requirements. Specifically excluded from the reporting requirements for SAEs under this provision is any SAE identified in the Protocol as anticipated to occur in the Study population at some frequency independent of drug exposure, unless the Principal Investigator assesses such an event as related to the Pfizer Product.
  • SAE Reporting Period. The SAEs that are subject to this reporting provision are those that occur from after the first dose of the Pfizer Product through 28 calendar days after the last administration of the Pfizer Product, or longer if so specified in the Protocol. In addition, if Principal Investigator becomes aware of an SAE occurring any time after the administration of the last dose of the Pfizer Product, Principal Investigator should report that SAE to Pfizer if the Principal Investigator suspects a causal relationship between the Pfizer Product and the SAE.
  • Follow-Up Information. Principal Investigator will assist Pfizer in investigating any SAE and will provide any follow-up information reasonably requested by Pfizer.
  • Regulatory Reporting. Reporting an SAE to Pfizer does not relieve Principal Investigator of responsibility for reporting it to appropriate regulatory authorities, if such reporting is required.
  • Pfizer-Provided Training. Pfizer will make available training material that provides information about the SAE reporting requirements for IIR studies. Principal Investigator will review this material and share it with any Study staff engaged in the reporting of SAEs.

In addition, Pfizer requires reporting of all non serious adverse events for any non-interventional clinical study with at least one study site in the European Economic Area.

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Can an exception be made for certain applicants regarding the eligibility criteria to the ASPIRE I-CRP awards?

In keeping with the purpose and intention of the ASPIRE I-CRP awards, applicants must meet all the criteria in order to be considered for an award. Submissions outside these parameters will not be considered.
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I’m still not sure if my proposed research topic meets the criteria, how can I find out?

Please contact the ASPIRE I-CRP Coordinator with a brief description of your proposed research area.

Email: Jolanda.vanBodegraven@pfizer.com
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Is there a time limit for conducting the funded research?

Study results are expected 18 months maximum after the signature of the contract.
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How do I apply for an ASPIRE I-CRP award?

Applications are to be submitted to Pfizer through an online submission website. Visit www.europeaspire.org go to the Dutch ASPIRE I-CRP tab and click on “apply”. From there you will be routed to Pfizer’s global investigator-initiated research website. Click on “Submit an IIR Request” and follow the online instructions. When asked if you are applying for a competitive grant program, select yes. Then, select the appropriate program name from the dropdown list.

Completed applications must be accompanied by the following documents:

  • FULL finalized protocol (summary, objectives, introduction, methods, references) with a maximum of 2000 words excluding references
  • Abbreviated curriculum vitae (CV) (limited to 3 pages)
  • Budget for proposed research
  • Cover letter on institution letterhead
  • 3 of the most relevant articles from the Applicant’s scientific publications (if applicable)
  • Description of available laboratory facilities
  • Listing of other research support available with a description of overlap and, if applicable, a listing of consenting collaborators (including CVs)
  • Bibliography of relevant references

I’m having difficulty submitting my application online, who do I contact for assistance?

Receive assistance by contacting iir@pfizer.com
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What is the deadline for application?

June 1st 2017 at 24.00 hrs CET
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When will I hear whether my application has been successful?

September 2017.

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If my application is successful, when will the funding commence?

Awards will commence about 2 months after the notification of the selection, pending receipt of all required documents noted on the application form. Contracts that are unable to be executed by the end of November 2017 are subject to loss of funding.
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Will I receive a copy of the Review Committee’s evaluation of my grant proposal?

Unfortunately, we are not able to provide applicants with comments by the ASPIRE I-CRP Review Committee. Our objective is to keep our administrative costs as low as possible, preserving the bulk of our budget for actual grants.
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Can Pfizer drug be provided?

The program can provide Pfizer drug if requested as part of the submission. Funding cannot be provided to purchase Pfizer drug.
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I have a question that is not covered here?

If you require clarification on an issue not addressed here, please contact the ASPIRE I-CRP Coordinator,

email: Jolanda.vanBodegraven@pfizer.com
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