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Translational Neural Devices (UG3/UH3 - Clinical Trial Optional)

List of required information for application:

1. Project Title: The proposed title of the project.

2. Project Description: A detailed description of the project, including the purpose, objectives, and methodology.

3. Nervous or Neuromuscular Disorder: Specify the specific disorder that the therapeutic or diagnostic device is intended to address.

4. Translational Activities: Describe the specific translational activities that will be pursued as part of the project.

5. Clinical Prototype Devices: Provide information on the clinical prototype devices that will be implemented as part of the project.

6. Non-Clinical Safety and Efficacy Testing: Outline the planned non-clinical safety and efficacy testing process for the devices.

7. Design Verification and Validation Activities: Explain the design verification and validation activities that will be conducted to ensure the efficacy and safety of the devices.

8. Investigational Device Exemption (IDE) or Institutional Review Board (IRB) Approval: Describe the plan for obtaining either an IDE for a Significant Risk (SR) study or IRB approval for a Non-Significant Risk (NSR) study.

9. Subsequent Small Clinical Study: Provide details on the proposed small clinical study that will provide additional information about the device function or final design.

10. Non-Clinical Assessments: Explain why additional non-clinical assessments, such as benchtop or animal studies, are not practical or sufficient for obtaining the required information about the device.

11. Milestone-Driven Cooperative Agreement Program: Acknowledge the milestone-driven nature of the cooperative agreement program and the involvement of NIH program staff in project planning and monitoring.

12. Research Progress: Provide a plan for monitoring and reporting on the progress of the research throughout the project timeline.

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Funding Amount

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Eligible Applicants

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Eligible Activities

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Deadline to Apply

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88%

Approval rating across all Canadian funding programs

93%

Average time savings to our clients, compared to
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