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NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R33 Clinical Trial Required)

List of Required Information for Application:

1. Project Title

2. Principal Investigator (PI) name and contact information

3. Co-Principal Investigators (if applicable)

4. Institutional affiliation(s) of PI and other key personnel involved in the trial

5. Project Summary/Abstract

6. Research Plan, including:

   a. Background and Significance

   b. Specific Aims

   c. Study Design and Methods

   d. Data Analysis Plan

   e. Expected Outcomes and Impact

7. Research Team and Expertise, highlighting the qualifications and experience of key personnel

8. Human Subjects Protections, including:

   a. Inclusion/Exclusion Criteria

   b. Recruitment and Retention Plan

   c. Informed Consent Process

   d. Ethical Considerations

   e. Data Safety Monitoring Board (DSMB) Plan

9. Regulatory Approvals, including:

   a. FDA Approval Plan

   b. Institutional Review Board (IRB) Approval Plan

10. Drug (and placebo) Supplies, including:

    a. Availability and Sources

    b. Quality and Stability

11. Budget, including:

    a. Personnel Costs

    b. Supplies and Equipment

    c. Clinical Services

    d. Regulatory Costs

12. Timeline and Milestones, including projected start and end dates for the trial and key activities

13. Plan for Dissemination and Translation of Findings

14. Collaborations and Partnerships, if applicable

15. Letters of Support from Collaborators or Partner Organizations, if applicable

16. Conflict of Interest Disclosures for all key personnel

17. Data Sharing Plan

18. NIH Biosketches/CVs for PI and key personnel

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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
businesses that apply for funding in-house
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