Clinical Trial Awards and Research Funding Agreements

Once selected for a Foundation Research Award, the Program Manager responsible for your award will help put a Clinical Trial Award (CTA) or Research Funding Agreement (RFA) in place and will then track, review, and authorize payment based on completion of research milestones. In general, the first installment of the award will be paid once the CTA/RFA is fully executed by all parties.

While Clinical Trial Awards are generally paid and invoiced based on patient visits, Foundation Research Funding Agreements (RFAs) are paid based on the receipt and approval of deliverables, each of which is associated with a research milestone. These are clearly laid out in an exhibit to the RFA, and thus the first activity following notification of selection for an award is establishing the Schedule of Milestones and Deliverables exhibit to the funding agreement. The Program Manager assigned to your award will work directly with the project PI to come to a mutually agreed upon schedule of milestones and deliverables.

For both agreement types, once all exhibits are approved by The Foundation and the Funded Investigator, your Project Manager will compile a full RFA and send via e-mail to the PI and their institutional Grants and Contracts department for review. Any changes to the template language will need to be discussed with and approved by the Foundation Director of Operations and Foundation legal counsel.

Project Progress

Progress Reports (RFA)

Once the RFA is fully executed by all parties, your Program Manager will share with the PI an updated Schedule of Milestones and Deliverables with actual dates. Your RFA Project Manager will send an e-mail reminder a few weeks ahead of each deliverable deadline and will also be responsible for reviewing deliverables for scientific content and clarity. Any substantive questions regarding or omissions in the deliverable must be addressed before the Program Manager can approve the next installment of the award.

Progress Report Template

Monthly Recruitment Updates (CTA)

Monthly recruitment updates are required as part of any Clinical Trials award. These do not apply to Pre-Clinical Awards. Screening logs need to be completed on a monthly basis, in English and saved as a pdf. All completed logs should be sent to Robin Jones, Director of Clinical Trials Coordination, .

Screening Log Template

Final Report

The final deliverable on your project should be a comprehensive report in the format of a conference proceeding and should be uploaded directly to the FocUS archive by the PI.

Final Report Template

Presentation

In order to promote awareness of the research funded by the Foundation, presentation of your work at the International Symposium on Focused Ultrasound is required as part of the funding agreement. The International Symposium on Focused Ultrasound is currently held biennially on even years.

Publication

In most cases, one final payment is linked to submission of a manuscript on the topic of your research project to a peer-reviewed journal.

Ongoing Responsibilities

For three years following the conclusion of the Foundation award, we request that you inform the Foundation of any IP generated or licenses resulting from Foundation funded work (this is also detailed in the CTA/RFA). Additionally, we would like to be informed of any follow-on funding you earn based on data collected through your Foundation-funded project. One of the strongest measures of success we have for projects is the ability to receive follow-on funding. We also use this information to compute a leverage on initial investment figure for our philanthropic donors.

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