Letters of Request for Permission to Submit an Application for a Clinical Trial Implementation Cooperative Agreement (U01) with Budgets $500,000 or More in Direct Costs per Year

Updated October 5, 2016

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is committed to improving the health of patients with rheumatic, musculoskeletal, and skin diseases by supporting investigator-initiated clinical trials. The NIAMS's goal is to identify and support trials that are timely and informative, and that will lead to improvements in clinical practices for disease prevention, diagnosis, and treatment.

The NIAMS supports investigator-initiated, clinical interventional trials through a Clinical Trial Implementation Cooperative Agreement (U01) that supports the complete implementation and conduct of the study. These studies are often complex, involve a large number of subjects or are higher risk, and we strongly recommend speaking with a NIAMS Program Officer prior to submission of an application. These larger and more complex trials require substantial planning and preparation prior to opening for recruitment. Investigators are encouraged to apply for a NIAMS Clinical Trial Planning Grant (R34) before applying for the U01 to implement the trial.

Investigators who are considering applying for a Clinical Trial Implementation Cooperative Agreement (U01) with a budget of $500,000 or more in direct costs in any year must consult with the NIAMS ahead of time to ensure the Institute will accept an application, as per NIH policy. Potential applicants must submit a LOR to the NIAMS that addresses each of the items below at least 10 weeks prior to the application due date. Please see the milestone checklist for LOR due dates.

Note that the NIAMS may require up to 10 weeks when making a decision as to whether to accept a U01 application with a budget of $500,000 or more in direct costs. Please consider this when constructing the grant application submission timeline. The NIAMS will inform the applicant by email of the decision.

Letter of Request (LOR) for a U01

All clinical trial planning milestones must be in place prior to submitting the LOR for Clinical Trial Implementation (U01) applications with budgets of $500,000 or more in direct costs in any year. The LOR must include:

  • Number and title of the U01 funding opportunity announcement
  • The intended U01 application submission date
  • Name, institutional affiliation and address, telephone number, and email address of the PD(s)/PI(s)
  • Names of all key personnel and participating institutions
  • Title and description of the proposed research (not more than one page)
  • A brief description of the plans for considering gender, minority status and children in the enrollment plan
  • If a prior R34 or U34 was funded to plan the U01, include any refinements or changes in the Principal Investigator(s), rationale, objectives, protocol, study sites, and industry partners for the proposed trial, from that outlined in the R34/U34 application
  • A table that details the requested budget include major budget categories (key/senior and other personnel, equipment, travel, trainee support, other direct costs), indirect costs, and total costs for each year of the requested application
  • A separate page with the title of the proposed research study and a one-page synopsis of the likely impact of the proposed study on disease prevention, diagnosis, or treatment
  • A separate document that summarizes each of the planning Milestones and provides a status of each task. Any tasks that remain to be completed must be detailed and justified before the trial can open for recruitment. Please use the Clinical Trial Planning Milestone Checklist to submit this information.

Contact information to submit an LOR for a U01:

Shahnaz Khan, MPH
Telephone: 301-451-9893
Fax: 301-480-4543
Email: Khanshah@mail.nih.gov