Pre-Application (X02) Instructions

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 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-15-287." At the time of notification, investigators will be provided with letters of support from the Clinical Center and the appropriate Institute/Center.

Instructions:

The X02 pre-application is strongly encouraged, though not required. X02 pre-applications are due by December 15, 2016.

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 Grants.gov. 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 strongly encouraged but not required
  • For those applicants opting not to use the Multiple PD/PI model, the intramural investigator can hold any role other than the PD/PI role
  • For those applicants who opt to use the Multiple PD/PI model, the intramural PI will also need to be registered in the eRA Commons. See "Special Instructions for Intramural Principal Investigators"

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 Principal Investigator or Co-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

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., and NOT required for the X02 pre-application.
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This page was last updated: 01/26/2017