U34 Multi-Center Clinical Study Cooperative Agreement
NIDDK Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34)
NIDDK supports investigator-initiated, multi-center (three or more sites) clinical studies exclusively through a two-part process that includes an implementation planning cooperative agreement (U34). The U34 is designed to: (1) permit early peer review of the rationale for the proposed clinical study; (2) permit assessment of the design and protocol of the proposed study; (3) provide support for the development of documents needed for the conduct of the study, including a manual of operations; and (4) support the development of other essential elements required for the conduct of a clinical study. Completion of the required products of a U34 is a prerequisite for submission of a multi-center clinical study cooperative agreement (U01) application, which will support the actual conduct of the study. Consultation with NIDDK staff is strongly encouraged prior to the submission of the U34 application.
|Notice(s) for this Opportunity|
August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
|Letter of Intent Due Date|
30 days before the application due date
|Application Due Date|
April 15, 2014; February 19, 2015; June 17, 2015; April 18, 2016; February 14, 2017, by 5:00 PM local time of applicant organization.