Collaboration Requirements
The extramural and NIH intramural investigators must develop the application together. Close collaboration will strengthen both the pre-application request and the full application.
The NIH intramural investigator should help develop the budget, including the NIH Clinical Center budget when study drugs are involved. The intramural investigator should also help describe how the team will work together and how the project will increase patient activity within the NIH IRP.
Patient and Stakeholder Engagement
The application must show how patients and other stakeholders will have a meaningful role in project decisions and activities. Explain how input from the relevant disease community informed the study design and outcome measures.
Project Period and Timeline
The active research phase should not exceed four years. Applicants may request a fifth year when year 1 is devoted to planning and regulatory approvals. The year 1 budget should be lower to match the reduced level of research activity.