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Opportunities for Collaborative Research at the Clinical Center (U01)

Pre-application process

The pre-application process is a required step in order to determine which applications can be supported by the resources of the NIH Clinical Center and align with the research missions of the participating NIH Institutes. Applicants will be notified of the opportunity to submit a U01 application under PAR-25-407 and, at the time of notification, investigators will be provided with letters of support from the Clinical Center and the appropriate Institute/Center. Included in the CC Letter of Support will be an indication as to whether the NIH Clinical Center is able to absorb the costs of the study drugs or if this cost will need to be covered by the grant, by the IC, or by industry sponsorship.

Instructions:

Required Information for LOS

Project title

• Provide the anticipated project title for the proposed project.

Use of Multiple PD/PI Model

• Multiple PD/PI model is allowed but not required in this NOFO

Use of co-PD/PI designation

• In order to recognize the increased involvement and responsibilities of the lead intramural investigator(s), at least one NIH intramural investigator must serve in the role of co-PD/PI.

Collaboration Plan - The following areas should be addressed:

• Organizational structure
• Management plan detailing how existing resources, including unique resources available through the NIH Clinical Center, will be utilized.
• Planned interaction and responsibilities of key personnel
• Description of how research teams will communicate (e.g., videocast, web meeting, etc.)
• Available resources and details of how these resources will be shared

Research Strategy - The following areas should be addressed (6 page limit):

• Size and scope of the research project and specific resources needed
• Tables, graphs, figures, diagrams, and charts
• Description of how the application fulfills the required components of the X02.
• Identification of at least one NIH intramural scientist as a Co-Program Director/Principal Investigator
• Description of each investigator's effort to the project and responsibilities of each
• Description of the portion of research that will be conducted at the NIH Clinical Center; information detailed in the table below should also be provided

Study Drugs - The anticipated cost of study drugs should be addressed:

• The only NIH Clinical Center costs which may be included in the budget section of the U01 application are the cost of drugs that are the subject of the study. It is recommended that, when possible, investigators work with pharmaceutical partners to minimize the cost of the study drugs. The Letter of Support from the NIH Clinical Center will indicate whether or not the CC is able to absorb the cost of any of the study drugs. Expensive treatments (i.e. protocols with drug costs expected to exceed $25,000/yr) will need to be paid for by the grant, by the IC, or through industry sponsorship.

For projects involving patients	Brief description of the research population (pediatric, geriatric, behavioral health, etc.); Inpatient/outpatient or both; Estimate of number of patients and their approximate lengths of stay/clinic visits List of special procedures/tests, and the estimated number of patients undergoing the procedures/tests
For All Projects	Description of special Clinical Center or intramural resources (technology/specimens/etc.) your project will use.

Information NOT required for LOS

These materials will, however, be required for the companion U01 application.

• Budget information is NOT required for the LOS.
• Appendix material is NOT required for the LOS.
• For research projects that include a clinical trial, attachments such as the Clinical Protocol, Statistical Analysis Plan, Data and Safety Monitoring Plan, Informed Consent Forms, etc., are NOT required for the LOS.