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Notice of Intent to Publish a Funding Opportunity Announcement for Clinical High Risk for Psychosis Clinical Trial Network (U01 Clinical Trial Required)

List of Required Information for Application:

1. Project Title: The application should include a clear and concise title for the proposed project.

2. Project Summary: A brief summary of the proposed project, including the objectives, methods, and expected outcomes.

3. Research Plan: A detailed research plan outlining the specific aims, background, methodology, and timeline of the proposed clinical trial.

4. Study Design: A description of the study design, including the target population (individuals at clinical high risk for psychosis), intervention(s) to be tested, and control/comparison groups (if applicable).

5. Outcome Measures: A description of the biological and clinical outcome measures that will be evaluated in the proof of principle trials using pharmacological interventions. This should include information on how these measures will be validated and their relevance to the study aims.

6. Collaborations: Details of any meaningful collaborations that have been developed or are planned, including the names and affiliations of the collaborating organizations or individuals.

7. Drug Development Tools: An explanation of how the unique drug development tools generated through the Accelerating Medicines PartnershipÔøΩ Schizophrenia (AMPÔøΩ SCZ) initiative will be validated in the proof of principle trials.

8. Project Team: Information about the proposed project team, including their qualifications, expertise, and roles in the project.

9. Budget: A detailed budget justification, including information on how the requested funds will be used and any other sources of funding or support for the project.

10. Timeline: A project timeline outlining the key milestones and activities of the proposed research.

11. Potential Challenges and Mitigation Strategies: Identification of potential challenges or limitations of the proposed research and strategies to address or mitigate these challenges.

12. Ethical Considerations: A discussion of any ethical considerations related to the proposed research, including human subjects protections and informed consent procedures.

13. Expected Outcomes: A description of the expected outcomes and impact of the proposed research, including any potential implications for clinical practice or policy.

14. References: A list of relevant references to support the proposed research and demonstrate the applicant's knowledge of the field.

15. Biosketches/CVs: Biosketches or curriculum vitae of key personnel involved in the proposed research, including relevant publications and past research experience.

16. Letters of Support: Letters of support from collaborators, institutional leaders, or other relevant stakeholders endorsing the proposed research and confirming their willingness to provide necessary resources or support.

17. Other

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Eligible Applicants

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Eligible Activities

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Deadline to Apply

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