Investigator-Initiated Multi-Center Clinical Studies
NIDDK will support investigator-initiated, multi-center clinical studies exclusively through a two part grant process: (1) an implementation planning (U34) grant followed by (2) a cooperative agreement (U01) to conduct the study.
Multi-Center Clinical Study Implementation Planning (U34) Grant
Beginning with the March 19, 2008 application receipt date, NIDDK will support implementation planning (U34) grants for multi-center clinical studies. These grants are intended to support all administrative study group activities that are required in order to begin recruitment of subjects. These activities include, but are not limited to: establishing the research team, developing the tools for data management and oversight of the research, defining the recruitment strategies, finalizing the protocol and investigators brochure, writing the Manual of Operations, establishing a data and safety monitoring plan and initiating the IRB approval process. The U34 is not designed for the collection of preliminary data, for the conduct of pilot studies to support the rationale for a clinical study, or for the design of the study. The U34 application will include the proposed study design.
All multi-center clinical studies must complete this two-part process, unless an exemption from this requirement is obtained. The U34 grant will provide up to two years of support. Pre-approval from NIDDK will be required for submission of an U34 application. U34 applications will be peer reviewed by special emphasis panels set up by the NIDDK Review Branch.
The product of an awarded U34 will be an application (U01) to conduct the clinical study. It is expected that receipt of a U34 grant will lead to the timely submission of an application for support of the full-scale study, incorporating the elements developed under the planning grant. Prospective applicants should note that funding of a U34 does not guarantee or imply funding for a subsequent application.
Multi-Center Clinical Study Grant (U01)
NIDDK will accept, peer review, and consider for funding applications for multi-center clinical studies only from U34 awardees, except in cases where an exemption from this requirement has been provided by NIDDK. In order not to delay the initiation of the multi-center clinical study (U01), the peer review and award of grant will be completed within four months of the receipt of the application when possible.
More detailed instructions regarding the multi-center clinical study application process are contained in two program announcements, see below. The instructions under each PA give the details pertaining to the preparation and submission of the approval request letter.
PA: NIDDK
Multi-Center
Clinical Study Implementation Planning Grants (U34)
Instructions for preparing and submitting a U34 Approval Request Letter
PA: NIDDK Multi-Center Clinical Study Cooperative Agreement (U01)
Instructions for preparing and submitting a U01 Approval Request Letter
Page last updated: December 19, 2007
