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NEI Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U01 Clinical Trial Required)

List of required information for application:

1. Project Title

2. Grant Number

3. Principal Investigator(s) name and contact information

4. Collaborating institutions and their contact information

5. Project Summary/Abstract

6. Project Goals and Objectives

7. Background and Significance of the Research

8. Research Design and Methods

9. Proposed Intervention(s) for screening, diagnosing, preventing, or treating vision disorders

10. Target Population for the study

11. Study Design and Sample Size Justification

12. Data management and analysis plan

13. Timeline for the study

14. Budget and Justification for funding

15. Previous and Current Research Support for all investigators involved

16. Description of the Institutional Support and Facilities available for the study

17. Plans for Oversight and Safety Monitoring of the trial

18. Any previous experience conducting clinical trials in vision disorders 

19. Potential Risks and Mitigation Strategies for the proposed study

20. Evaluation and Outcome Measures

21. Dissemination and Reporting Plan for study results

22. References or Bibliography related to the proposed study

23. Assurance of Compliance with Institutional Review Board (IRB) Regulations

24. Protection of Human Subjects and Ethical Considerations

25. Additional supporting documents such as CVs, Letters of Support, and other relevant attachments.

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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%

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