Policies and Guidelines for Investigator-Initiated Clinical Trials — Frequently Asked Questions (FAQs)

Updated May 18, 2015

  1. Where can I find Funding Opportunity Announcements and Key Dates for the NIAMS Clinical PARs (Clinical R21s, U34 and U01)?

    Exploratory Clinical Trial Grants (R21) PAR-14-192
    Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01)
    NIAMS Clinical Trial Planning Grants (U34)
    NIAMS Clinical Trial Implementation Cooperative Agreement (U01)

  2. Which PAR is most appropriate for my proposal?

    It depends. Please speak to your Program Director for guidance.

  3. What if Iíve already met my planning milestones — do I have to apply for a U34 first?

    It depends. Please speak to your Program Director for guidance. If adequate written documentation can demonstrate that the appropriate planning milestones have been achieved, a planning grant may not be needed.

  4. My trial is for a single site. How do I apply?

    Through the U01 mechanism. The NIAMS Clinical Trial Implementation Cooperative Agreement (U01) mechanism is appropriate for either a multi-site or a single site clinical trial application.

  5. My trial has multiple sites that will be enrolling research participants. How do I apply?

    Through the NIAMS Clinical Trial Implementation Cooperative Agreement (U01) mechanism.

  6. Do I have to submit both a Letter of Intent (LOI) and a Letter of Request (LOR) when applying to one of these mechanisms?

    No. A Letter of Intent (LOI) is not required, but it is encouraged for U34 applications and U01 applications that have budgets under $500,000 in direct costs per year. A Letter of Request (LOR) is only required for U01 applications that will have budgets of $500,000 or greater in direct costs in any given year.

    An LOR requires substantially more detail and must be submitted for the NIAMSís consideration at least 10 weeks in advance of the application due date. You will be notified by the NIAMS if your LOR is accepted and you may submit a U01 application (Note: permission is only needed if the application has a budget requesting direct costs equal to or greater than $500,000 in direct costs in any given year).

  7. What are the due dates for the Letter of Request (applications with budgets of $500,000 or greater in direct costs in any given year) for a U01 Clinical Trial Application?

    Application Due Date Letter of Request Due Date (required 10 weeks prior to the application due date)
    July 1, 2015 April 22, 2015
    November 2, 2015 August 24, 2015
    March 1, 2016 December 22, 2015
  8. What are the due dates for the Letter of Intent (U01 applications with budgets of less than $500,000 in direct costs in any given year and all U34 applications)?

    The Letter of Intent is requested 30 days prior to the application due date.

  9. Should I complete a one-page specific aims section of the U34 application? If so, should I include the aims of the planning activities and the clinical trial?

    It is not required to include the specific aims of the clinical trial in the one-page specific aims section, but it is not discouraged. If you choose to include both, please make sure the planning project specific aims are clearly delineated from the clinical trial specific aims. A key reference from the FOA for you to consider when including or excluding details about the clinical trial is:

    "Sufficient details of the clinical trial (such as overall study design, primary objective, inclusion and exclusion criteria, proposed study population, proposed study agent(s), sample size, study end points and duration of recruitment and follow-up) should be included to permit assessment of the scientific importance and feasibility of the trial. In instances where basic protocol development can only be completed with U34 funding, the application should indicate why this is the case and indicate how the support will be used to complete the design of the study. The application must describe and address the availability of the requisite patient/subject population and plans for recruitment outreach and follow-up. In addition, plans for addressing issues and challenges regarding adherence to the proposed intervention protocol should be included."

  10. The U34 FOA states that individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. What does this mean?

    For the U34, a resource sharing plan is not required.

  11. Should the modular budget form be used for the U34, since direct costs should be $250,000 per year or less?

    The NIAMS Clinical Trial Planning Cooperative Agreement (U34) (PAR-15-166) must use the modular grant application (Source of information: https://grants.nih.gov/grants/funding/modular/modular.htm)

  12. How should appendices be submitted?

    All components of the application, including appendices, must be submitted electronically at the time of submission of the application through grants.gov. Please note that applications that lack the documents required in the appendix will be considered incomplete and will not be reviewed.

  13. A PI who previously submitted an R34 did not get funded. Can he or she apply for a new U34?


  14. Does the F&A for consortiums count against the direct cost limitation?

    No. In calculating direct cost level, the applicant should not include the F&A costs associated with any consortium/contractual arrangements. Those costs may be requested above the direct cost limit. Fields are provided to separately capture consortium F&A costs for each budget year.

  15. What is the page limit for my application?

    Please follow the page limitations described for each PAR. Refer to https://grants.nih.gov/grants/guide/url_redirect.htm?id=11132

  16. If I have already completed an R34, how should I seek permission to apply for a U01 without applying for a U34?

    Please speak directly to a NIAMS Clinical Research Manager or a NIAMS Program Director regarding the accomplishments of your R34 and how documentation should be submitted.

  17. Can I submit an R01 clinical trial application?

    See NOT-AR-14-021. NIAMS will not accept investigator-initiated R01 applications and subsequent revisions containing clinical trials submitted to PA-13-302 "Research Project Grant (Parent R01)". Applicants submitting investigator-initiated applications to NIAMS that contain a clinical trial must respond to one of the NIAMS funding opportunity announcements (FOAs) specifically designed for clinical trials, the descriptions of which may be found at the following link: https://www.niams.nih.gov/Funding/Clinical_Research/clinical_main.asp. Please speak to a Program Director regarding the revised application and how to submit.

  18. I have a funded R01, multi-site, pilot and feasibility trial. I would like to conduct a larger, definitive trial and would like to know if I should apply for a competing continuation or a Clinical Trial Implementation (U01) grant. Also, since I have completed some planning activities under the R01, am I exempt from the U34 planning requirements?

    Please speak to your Program Director to determine the appropriate options to apply for a clinical trial. The planning milestones achieved under the pilot and feasibility trial must be discussed with the Program Director. You must submit a written justification for requesting an exemption from the U34 planning requirement.

  19. Would the NIAMS accept an investigator-initiated study for a clinical trial if the necessary materials for the planning phase were demonstrably complete through funding resulting from a foundation grant or other private source of funding?

    If certain required elements of the planning phase have been completed using another funding source, the NIAMS will take this into consideration when making a decision about whether the applicant is ready to submit directly to the U01. However, you are strongly advised to engage in a discussion with a NIAMS Program Director and the Clinical Research Managers to discuss the planning milestones that have already been accomplished and how you should provide documentation and justification to demonstrate this.

  20. The NIAMS Investigator-Initiated Clinical Trials Policies found at: https://www.niams.nih.gov/funding/clinical_research/clinical_policy.asp indicates that when the planning and administrative tasks are already in place, for example by current R34 awardees, an investigator may request an exemption from the planning phase (i.e., U34 planning grant) and apply directly for U01. What is the process for applying for a U01 without a preceding U34?

    Please speak to a NIAMS Clinical Research Manager and a NIAMS Program Director first. You must be able to document that the planning and administrative tasks are already completed, or justify why they are not needed. In general, the elements found at https://www.niams.nih.gov/funding/clinical_research/clinical_milestones.asp need to be in place before a complete U01 clinical trial application can be submitted, although different circumstances for different types of trials may be allowed. This document is separate from the Letter of Intent (LOI) or Letter of Request (LOR).