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Opportunities for Collaborative Research at the Clinical Center (U01)

Pre-Applications (X02) and Requests for LOS

The funding announcement for Opportunities for Collaborative Research at the NIH Clinical Center (X02) is a pre-application that serves as the recommended first step in submitting a U01 application. Please read the full announcements for both the X02 pre-application and U01 application.

This X02 announcement will not result in an award. Instead, investigators whose X02 pre-applications can be supported by the resources of the NIH Clinical Center and align with the research missions of the participating NIH Institutes will be notified of the opportunity to submit a U01 application under PAR-21-343. 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.


The X02 pre-application is strongly encouraged, though not required. The due dates for the X02 pre-applications are listed in the FOA. If you have missed the X02 application deadline you may submit a Request for Letters of Support (LOS).

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the "Apply for Grant Electronically" button in this X02 or following the directions provided at Applicants should carefully read the full X02 as well as the applicable portions of the SF 424 (R&R) Application Guide.

Required Information for X02 Pre-application

Use of Multiple PD/PI Model

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

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 within the 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

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 X02 Pre-application

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

  • Budget information is NOT required for the X02 pre-application.
  • Appendix material is NOT required for the X02 pre-application.
  • 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 X02 pre-application.

Alternate Pre-application submission instructions:

While the X02 pre-application is strongly encouraged, it is not required. Instead of submitting an X02, you may submit a Request for Letters of Support. Even though you will be submitting an email rather than an electronic X02, you will still need to provide the same information listed above for the X02, including a project title.

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