Policies and Guidelines for Investigator-Initiated Clinical Trials

Reviewed March 21, 2012

What are the application due dates for the U34 and UM1/U01?

2011	2012	2013	2014
July 1	March 1	March 1	March 1
November 1	July 1	July 1
	November 1	November 1

2011	2012	2013	2014
July 1	March 1	March 1	March 1
November 1	July 1	July 1
	November 1	November 1

2011	2012	2013	2014
August 1	March 1	March 1	March 3
November 1	July 2	July 1
	November 1	November 1

What if I’ve 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 be provided that the appropriate planning milestones have been achieved, a planning grant may not be needed.

The UM1 appears to be for multi-site trials – what does this mean?

The NIAMS is using the UM1 mechanism to solicit applications for multi-site clinical trials.

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

Through the U01 mechanism. For purposes of this PAR, this will include a data coordinating site and one clinical site.

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 encouraged for U34 applications and UM1/U01 applications that have budgets under $500K/year. A Letter of Request (LOR) is only required for UM1/U01 applications that will have budgets of $500K/year or greater.

An LOR requires substantially more detail and is required to be submitted for the NIAMS’ consideration at least 6 weeks (10 weeks is preferred) in advance of the application due date. You will be notified by the NIAMS if your LOR is accepted and you may submit a UM1/U01 application (Note: permission is only needed if the application has a budget requesting direct costs equal to or greater than $500K in any given year).

What are the due dates for the Letter of Intent and for the Letter of Request?

2011	2012	2013
April 18, July 1*	April 15	April 15
August 15	August 15	August 15
December 15	December 15	December 15

2011	2012	2013	2014
April 22, May 23*	December 22, 2011	December 22, 2012	December 22, 2013
August 23	April 22	April 22
	August 23	August 23

* applies to UM1 and U34
** applies to U01

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?

While it is not required to include the specific aims of the clinical trial in the one- page specific aims section, 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:

“The study design and protocol for the proposed trial should be presented in the U34 application in sufficient detail so that a review group can judge the feasibility of the proposed approach and the potential significance of the trial. In instances where basic protocol development can best be completed with U34 funding, the application should indicate why this is the case and indicate how the funding will be used to complete the design of the study.”

The U34 FOA states that a resource sharing plan is generally expected, but not applicable for this FOA. Will you please clarify if NIAMS would like to receive a resource sharing plan?

No, a resource sharing plan is not applicable for this funding opportunity announcement.

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

The NIAMS Clinical Trial Planning Cooperative Agreement (U34) (PAR-11-169) must use the modular grant application (Source of information: http://grants.nih.gov/grants/funding/modular/modular.htm)

The UM1 FOA instructions for the required appendix materials state 5 CDs are to be sent to Charles Rafferty. I wanted to make sure that I am to send CDs for the appendices and not hard copies.
CDs are fine. If the PI has color images and detailed figures in the Research Plan, it would be a good idea to include a pdf file for the core application on the CDs as well.
A PI who previously submitted an R34 did not get funded. Can he come in as a new U34?

Yes

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.

What is the page limit for my application?

Please follow the page limitations described for each PAR.

For the U34, all page limitations described in the SF424 Application Guide and the Table of Page Limits http://grants.nih.gov/grants/guide/url_redirect.htm?id=11132 must be followed.

Research Strategy is limited to 12 pages.

For the U01, all page limitations described in the SF424 Application Guide and the Table of Page Limits http://grants.nih.gov/grants/guide/url_redirect.htm?id=11132 must be followed, with the following exceptions or additional requirements:

Research Strategy section is limited to 30 pages.
It is recommended that the Milestone section of the Research Strategy not exceed three (3) pages.
It is recommended that the clinical protocol synopsis part of the Protection of Human Subjects not exceed five (5) pages.

For the UM1, all page limitations described in the PHS398 Application Guide and the Table of Page Limits http://grants.nih.gov/grants/guide/url_redirect.htm?id=11132 must be followed with the following requirement:

Research Strategy section is limited to 30 pages.

If I have already completed an R34, how should I seek permission to apply for a UM1 or a U01 without applying for a U34?

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

I want to submit a revised R01 clinical trial application (A1). If I submit an R01 clinical trial application, will it be rejected? Or should I apply through a UM1/U01?

Please speak to a Program Director regarding the revised application and how to submit. The application for the revised R01 application will not be rejected, but clinical trials are encouraged to come in through the UM1 or U01 mechanisms and Investigators have an advantage for applying through these rather than the R01.

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 come in as a competing continuation or a UM1 application? 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. An application for a UM1 is encouraged. The planning milestones achieved under the pilot and feasibility trial must be discussed with the Program Director and written justification for requesting an exemption from the U34 planning requirement must be submitted.

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 UM1/U01. However, you are strongly advised to engage in a discussion with a NIAMS Program Director and the Clinical Coordinators to discuss the planning milestones that have already been accomplished and how documentation and justification to demonstrate this should be provided.

The NIAMS Investigator-Initiated Clinical Trials Policies found at: http://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 a UM1/U01. What is the process for applying for a UM1/U01 without a preceding U34?

Please speak to a NIAMS Clinical Coordinator and a NIAMS Program Director first. The investigator must be able to document that the planning and administrative tasks are already completed or provide a justification as to why they are not needed. In general, these are the same elements found at http://www.niams.nih.gov/funding/clinical_research/clinical_milestones.asp, the principle being that these are the elements that need to be in place before a complete UM1/U01 application could be submitted, although allowing for different circumstances for different types of trials. This document is separate from the Letter of Intent (LOI) or Letter of Request (LOR).