List of Required Information for Application:
1. Project Title: The title of the proposed clinical trial.
2. Project Summary/Abstract: A brief summary of the proposed clinical trial, including the research objectives and importance.
3. Research Plan: A comprehensive scientific and operational plan that describes the clinical trial in detail. This plan should include information on study design, intervention(s), participant eligibility criteria, sample size determination, data collection and analysis methods, and statistical considerations.
4. Project Management: A description of how the project will be managed, including roles and responsibilities of the research team members, coordination of site activities, and communication and decision-making processes.
5. Subject Recruitment and Retention: A plan for recruiting and retaining participants in the clinical trial. This should include strategies for identifying potential participants, obtaining informed consent, and minimizing participant attrition.
6. Performance Milestones: A timeline of key milestones and deliverables for the clinical trial. This should include specific objectives and timelines for participant enrollment, data collection, analysis, and reporting.
7. Scientific Conduct of the Trial: A description of how the trial will be conducted in compliance with ethical and regulatory guidelines. This should include plans for monitoring participant safety, maintaining data integrity, and addressing any adverse events or protocol deviations.
8. Dissemination of Results: A plan for reporting and disseminating the findings of the clinical trial. This should include strategies for publication in scientific journals, sharing data with other researchers, and communicating results to study participants and the broader scientific community.
9. Collaborative Data Coordinating Center (DCC) Application: Confirmation that a separate application for a collaborating Data Coordinating Center (DCC) is being submitted on the same application due date.
10. Contact Information: Contact details for the primary investigator and other key personnel involved in the proposed clinical trial.
11. Budget: A detailed budget that outlines the requested funding for the clinical trial, including personnel salaries, equipment and supplies, participant recruitment and retention costs, data management and analysis expenses, and travel and dissemination costs.
12. Research Support: A list of any existing or pending support for the proposed clinical trial, including grants, contracts, or other funding sources.
13. Institutional Review Board (IRB) Approval: Confirmation that the proposed clinical trial has received or will seek approval from the appropriate IRB(s) prior to initiating any study activities.
