List of required information for application:
1. Project title and description: Provide a clear and concise title for the project, as well as a detailed description of the proposed multi-site clinical trial, including the research question, objectives, methodologies, and expected outcomes.
2. Applicant organization information: Include the name, address, and contact details of the organization applying for the grant.
3. Principal investigator information: Provide the name, qualifications, and expertise of the principal investigator who will be responsible for overseeing the DCC activities and coordinating with the collaborating CCC.
4. Collaborating Clinical Coordinating Center (CCC) information: Outline the details of the collaborating CCC, including the name, qualifications, and expertise of the principal investigator leading the CCC.
5. Research mission relevance: Explain how the proposed clinical trial aligns with the research mission of the NHLBI and its strategic priorities. Provide a strong justification for why this trial is important and how it addresses current gaps in knowledge.
6. NIH definition of a clinical trial: Demonstrate that the proposed trial meets the NIH definition of a clinical trial as specified in NOT-OD-15-015. Clarify if the trial falls under the categories of efficacy, comparative effectiveness, pragmatic, or implementation research.
7. Project coordination plan: Present a comprehensive plan for overall project coordination, administration, and data management. Describe how the DCC will provide support to the collaborating CCC in terms of logistics, recruitment, quality control, and study implementation.
8. Data management plan: Outline the procedures and protocols for data collection, storage, and analysis. Include details on data security, confidentiality, and data sharing practices.
9. Biostatistical support plan: Describe how the DCC will provide biostatistical support to the clinical trial. Explain the role of statisticians in data analysis, sample size determination, and statistical reporting.
10. Budget: Prepare a detailed budget, including justification for all expenses. Specify the funds required for project coordination, administration, data management, and biostatistical support.
11. Timeline: Provide a timeline for the entire duration of the project, including key milestones, deliverables, and anticipated completion dates.
12. Previous experience and qualifications: Highlight the relevant experience and qualifications of the applicant organization, principal investigator, and key personnel involved in the DCC. Include a list of previous clinical trial coordination and data management projects.
13. Letters of support: Obtain letters of support from collaborating sites, investigators, and any other relevant stakeholders who will
