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Opportunities for Collaborative Research at the Clinical Center (U01)

U01 Application Instructions

The extramural investigators should work closely with NIH intramural investigators. Working closely will help ensure the best chance that the pre-application is approved and the full application receives full consideration. This will include intramural investigator input on the budget (including the Clinical Center budget if study drugs are included - see Budget Instructions tab) as well as assisting the crafting of the description of how the team will work together and how the work will increase patient activity in the Clinical Center.

Patient and stakeholder input should be meaningfully incorporated into decisions and activities. Applications should include details of the process used for including disease community input on study design, including outcome measures.

While it is still expected that the research portion of the study plan will not exceed 4 years, new for this FOA is the ability to request a 5th year, where the first year is focused on planning activities and regulatory approvals with a commensurately smaller budget.

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