Extramural investigators should work closely with NIH intramural investigators to ensure the best chance of pre-application approval, and full consideration given to the full application. The intramural investigator will give input on the budget (including the Clinical Center budget if study drugs are included - see Budget Instructions tab) and assist in crafting 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, the applicant has the ability to request a 5th year, where the first year is focused on planning activities and regulatory approvals with a commensurately smaller budget.