Required information for application:
1. Project Scientist: Provide information about the NIDCD Project Scientist who will be collaborating with the investigator throughout the clinical trial.
2. Investigator: Provide information about the primary investigator who will be responsible for conducting the clinical trial.
3. Intervention: Describe the intervention being proposed for the treatment or prevention of communication disorders.
4. FDA Oversight: Explain why the clinical trial requires FDA oversight and provide any relevant documentation or justification.
5. Annual Direct Costs: Specify the annual direct costs for the clinical trial. If it is equal to or greater than $500,000, provide the exact amount. If it exceeds $700,000, provide the detailed budget breakdown.
6. Formal Establishment of Efficacy: Justify how the proposed clinical trial is intended to formally establish efficacy of the intervention.
7. Risk of Harm: Explain if the proposed clinical trial has a higher risk to potentially cause physical or psychological harm to participants and provide a detailed assessment of the potential risks and mitigation strategies.
8. Collaborative Agreement: Describe how the cooperative agreement between the NIDCD Project Scientist and investigator will benefit the clinical trial and ensure close interaction, oversight, and guidance.
9. Previous Clinical Trials: Provide information about any previous or ongoing clinical trials conducted by the investigator that are relevant to the proposed research.
10. Timeline: Outline the timeline for the clinical trial, including key milestones and anticipated completion date.
11. Impact: Describe the potential impact of the clinical trial on the field of communication disorders and the broader scientific community.
12. Budget: Provide a detailed budget for the clinical trial, including all anticipated expenses and justifications for each item.
13. Ethical Considerations: Describe how ethical considerations will be addressed in the clinical trial, including informed consent, participant safety, and data confidentiality.
14. Data Management: Outline the plans for collecting, managing, and analyzing the data generated during the clinical trial, including any data sharing or publication plans.
15. References: Include a list of relevant references cited in the application.