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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 January 12, 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 that lead to better clinical outcomes. The NIAMS's goal is to identify and support trials that are as timely and informative as possible, and that will lead to improvements in clinical practices for disease prevention, diagnosis, and treatment. To this end, the NIAMS has enhanced its clinical trials program.
The NIAMS supports investigator-initiated, clinical interventional trials through a two-part process: (1) a Clinical Trial Planning Grant (U34) followed by (2) a Clinical Trial Implementation Cooperative Agreement (U01) to fully implement and conduct the study. For investigators considering applying for either a U34 or a U01, we strongly recommend speaking with an NIAMS Program Director prior to submission of an application. These larger and more complex trials require substantial planning and preparation prior to opening for recruitment. Therefore, investigators will be expected to apply for a NIAMS Clinical Trial Planning Grant (U34) before applying for the U01 to implement the trial. In some cases, the U34 planning grant requirement can be waived, and direct submission of the implementation U01 may be permitted if it can be demonstrated that the planning tasks have been or will be accomplished prior to implementation of the clinical trial. Applicants should consult with the NIAMS to determine if the Institute will consider a U34 waiver request. Please refer to the Consultation and the Clinical Trial Planning and Implementation Milestones pages for more information.
Investigators who wish to propose a clinical trial should apply for funding through a NIAMS Clinical Trial Implementation Cooperative Agreement (U01), particularly if the proposed trial is complex or involves large numbers of subjects. It is expected that most trials will require substantial planning and preparation prior to opening for recruitment. Investigators will be required to apply for a NIAMS Clinical Trial Planning Cooperative Agreement (U34) prior to applying for the U01 to implement the trial unless a waiver to the U34 requirement is allowed by the NIAMS. Submission of a Letter of Request (LOR) for a U01 will be a milestone in the awarded U34 grants, which will be tailored to the specific planning activities required before implementation of the proposed trial.
Investigators who are considering applying for a Clinical Trial Implementation Cooperative Agreement 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.
Note that the NIAMS may require up to 10 weeks when making a decision as to whether to accept a large U01 application. Please consider this when constructing the grant application submission timeline. The NIAMS will inform the applicant by email or telephone of the decision.
Letter of Request (LOR) for a U01
All clinical trial planning tasks must be in place prior to submitting the LOR for U01Clinical Trial Implementation applications with budgets of $500,000 or more in direct costs in any year. The LOR must include:
- Name, institution affiliation and address, telephone number, and email address of the PD(s)/PI(s)
- Names of all key personnel and participating institutions
- Number and title of the U01 funding opportunity announcement
- The intended U01 application submission date
- Title and description of the proposed research (one page or less)
- A brief description of the plans for considering gender, minority status and children in the enrollment
- 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 U34 application (if applicable)
- 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 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 either under an ongoing U34 planning grant or otherwise before the trial can open for recruitment must be detailed and justified. Please use the Clinical Trial Planning Milestone Checklist to submit this information.
Contact information to submit an LOR for a U01:
Shahnaz Khan, MPH
Division of Extramural Research Activities
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Democracy One, Room 810
6701 Democracy Blvd.
Bethesda, MD 20892
Telephone: (301) 594-2463
Fax: (301) 480-4543