2011 Pfizer/Urology Care Foundation OAB LUTS Research Training Award Program
Conditions of the Award
The Research Training Award grants will be awarded to the host institution on behalf of the Awardee. It is anticipated that three awards will be granted in 2011 with a maximum of $ 37,500 USD per year ($75,000 USD for two years) including direct and indirect costs over a consecutive two-year period.
The amount of each award includes direct costs (labor and study costs), institutional overhead costs, and indirect costs (additional expenses such as publication, software license fees, and IRB fees). The institutional overhead costs cannot exceed 28% of the direct costs. Pfizer does not pay overhead on indirect costs. Each payment will be made in installments according to milestones, with a maximum of 50% of the funding delivered at the beginning of the project. The last installment of 15% will be made when the final results of the study are available.
Studies must be designed to be completed within 24 consecutive months after receipt of funding and/or drug supply, yielding results that would merit submission as an abstract to a scientific meeting and subsequent publication in a peer-reviewed journal.
Final budgets of those studies awarded a grant will be reviewed for fair market value before the contracting process begins.
A signed, executed contract must be returned prior to disbursement of funds. Contracts that are unable to be executed by the end of the calendar year are subject to loss of funding.
Financial Record Keeping
A separate financial record must be maintained by the Awardee.
Research Training Program Awards Progress and Final Reports
The Awardee must submit a final report on study results to Pfizer December 31, 2013. Reprints of articles published or in press, should be included with all reports. From time to time, Pfizer may ask Awardees for information on study progress.
Required Documents if Proposal is Selected for Funding
Required additional documentation if your proposal is selected for funding by the review committee (further guidance will be provided):
- Original letter documenting acceptance of support, written on institutional letterhead, and signed by the Investigator
- Two copies of the Signed Research Agreement
- IRB approval documentation, if applicable
- IND documentation , as applicable
- W-9 form for your institution
- Certification of Study Closure Form (provided at study completion)
Awardees are expected to present their findings at scientific meetings or to publish them in scientific journals. All publications that result from a project supported by the Research Training Program must carry the following acknowledgment: "This research was supported by Research Training Competitive Grants Program supported by Pfizer, to (name of Awardee)." Awardees will provide Pfizer with the opportunity to view manuscripts or abstracts 60 days prior to submission for publication or other public disclosure.
Patents and Licensing
If the conduct of the research results in any invention or discovery by the Awardee that relates to a Pfizer product, the Awardee will grant to Pfizer a perpetual, royalty-free worldwide, non-exclusive license to each such invention.
- Should the Awardee discontinue the research project or leave the designated host institution, the Research Training Program must be notified without delay.
- The Research Training Award may be transferred to another institution at the sole discretion of the Research Training Program, acting on the recommendation of the Review Committee Chair. If a transfer is requested, letters from the Awardee and the new institution must be submitted to the Research Training Program at least 3 months before the date of the proposed transfer.
- If the host institution or the Awardee wishes to terminate the award before its completion, an agreement between the host institution and the Research Training Program will be arranged. Termination will be made with the understanding that all unexpended funds will be returned to Pfizer and any unpaid balance of the award will be cancelled.
Serious Adverse Events (SAE) Reporting (As Applicable)
For all studies using a Pfizer product and/or device, Pfizer requires that, within 24 hours of first awareness of the event (or immediately if the event is fatal or life-threatening), the principal investigator will report to Pfizer by facsimile any SAE that occurs during the SAE reporting period in a study subject assigned to receive the Pfizer product. In addition, for studies using a Pfizer device or Pfizer product packaged with a device, reportable events include not only SAEs but also Device Incidents and Device Near-Incidents.
- Reporting Forms: The principal investigator will report such SAEs using the Pfizer IIR SAE reporting form or the approved local regulatory form (i.e., FDA MEDWATCH form, CIOMS, etc.) and the Reportable Event Fax Cover Sheet provided by Pfizer. SAEs should be reported as soon as they are determined to meet the definition, even if complete information is not yet available.
- Reporting Period: The Reportable Events that are subject to this provision are those that occur from after the first dose of the Pfizer product through 28 days after discontinuation of the Pfizer product.
- Follow-up Information: The institution and/or 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 the institution and/or principal investigator of the responsibility for reporting it to the FDA or local regulatory authority, as required.