Is the U01 Multi-center Clinical Study Cooperative Agreement limited to multi-center clinical trials?
No. The U01 Multi-Center Study Cooperative Agreement will support all types of multi-center clinical studies including epidemiologic studies, observational studies, and interventional clinical trials.
What is the definition of a multi-center study?
A multi-center study is one which is conducted at three or more sites. A study is considered to be "multi-center" if three or more sites are involved in the actual conduct of the study. A study will not be considered to involve multiple centers if participant recruitment occurs at three or more locations in a geographic area but all interventions and/or outcomes assessments are performed by a single study team.
Does NIDDK require a U34 before they will fund a U01 Multi-Center Clinical Study Cooperative Agreement?
No. NIDDK does not require a U34 if all the planning activities can be completed through some other mechanism. If you believe you have accomplished all the necessary planning required to conduct the clinical study, you may apply for the U01. However, the U01 application requires that you document that all necessary planning has been completed before you submit the U01 application. The recruitment of participants should be ready to begin as soon as a U01 award is made. No planning activities are allowed under the U01. It is the experience of NIDDK that clinical studies require extensive administrative planning (e.g., protocol finalization, manual of operations development, case report form design, data management and study oversight, etc.) before participant recruitment may begin. These activities require significant resources and personnel; thus, the administrative planning process typically begins after the study has been peer-reviewed and funded, using valuable time that is needed for the conduct of the study. The U34 Multi-Center Clinical Study Implementation Planning Cooperative Agreement mechanism will provide sufficient time and funds to complete detailed clinical study activities/documents necessary to comply with NIDDK standards and regulatory requirements. This will allow recruitment to begin once the U01 is awarded.
What is a U01 Multi-Center Clinical Study Cooperative Agreement Award?
The cooperative agreement (U01) is an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of multi-center clinical study activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role. Thus, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as described in the following program announcement: PAR-14-XXX.
What role will NIDDK play in U01 Multi-Center Clinical Study Cooperative Agreement?
The U01 Multi-Center Clinical Study funding mechanism will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for directing and executing the proposed multi-center clinical study with NIH staff being substantially involved as a partner with the Principal Investigator, as described under Cooperative Agreement Terms and Conditions of Award in PAR-14-XXX.