List of required information for application:
1. Project title: Provide a clear and concise title for the clinical study.
2. Investigator information: Include the names, affiliations, and contact information of all principal investigators and collaborating researchers involved in the study.
3. Collaborative sites: Specify the number of sites involved in the study and provide a brief description of each site's role and responsibilities.
4. Study objective: Clearly state the primary objective of the clinical study, focusing on mental health genetics, biomarker studies, or studies of mental illnesses associated with HIV/AIDS.
5. Study design: Provide a detailed description of the study design, including the specific protocols that will be shared across sites.
6. Sample size and recruitment: Explain how the collaboration between sites will increase the sample size, accelerate recruitment, or enhance sample diversity and representation.
7. Coordinating site: Identify the site that will serve as the coordinating R01 for data management and/or centralized administration for studies with a large number of sites.
8. Budget and funding: Outline the budgetary needs of the study, including personnel, equipment, supplies, and other expenses. Enumerate the requested funding amount and provide a breakdown of how the funds will be allocated.
9. Timeline: Present a timeline for the entire duration of the study, including specific milestones and projected completion dates.
10. Data management and analysis: Describe the plan for data collection, management, and analysis. Include details on how data confidentiality and privacy will be maintained.
11. Ethical considerations: Discuss any ethical considerations related to the study, including informed consent procedures, protection of human subjects, and potential risks and benefits.
12. Dissemination plan: Outline how the study findings will be disseminated to the scientific community and relevant stakeholders.
13. Collaborative agreements: Provide documentation of formalized collaborative agreements between the participating sites, including responsibilities, data sharing agreements, and intellectual property considerations.
14. Additional supporting documents: Include any additional supporting documents required by the funding agency, such as biosketches, letters of support, or relevant publications.
Note: The specific requirements for the application may vary depending on the funding agency and their guidelines. It is important to carefully review the application instructions provided in the Funding Opportunity Announcement (FOA) for any additional or specific information required.
