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U01 Frequently Asked Questions

Some of the most common questions about the U01 are answered below.

U01 Introduction

Why is NIDDK requiring a U34 Multi-Center Clinical Study Implementation Planning Grant before they will fund a U01 Multi-Center Clinical Study Cooperative Agreement?

​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. The U34 Multi-Center Clinical Study Implementation Planning Grant mechanism will provide sufficient time and funds to complete detailed clinical study activities/documents necessary to comply with NIDDK standards and regulatory requirements. The product of an awarded U34 Multi-Center Clinical Study Implementation Planning Grant will be an application (U01 Multi-Center Clinical Study Cooperative Agreement) to conduct the clinical study.
 
After successfully completing the administrative implementation activities of the U34 Multi-Center Clinical Study Implementation Planning Grant, investigators can apply for a U01 Multi-Center Clinical Study Cooperative Agreement grant and request up to 5 years to conduct the clinical study.


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-11-157.


What role will NIDDK play in U01 Multi-Center Clinical Study Cooperative Agreement grant?

​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-11-157.


U01 Peer Review

If the U34 grant is appropriately productive (e.g., protocol finalization, manual of operations development), will a U01 grant application still require peer-review?

​Yes. The U01 Multi-Center Clinical Study Cooperative Agreement application will undergo NIH peer-review. Specific review criteria used to evaluate U01 applications may be found within PAR-11-157 NIDDK Multi-Center Clinical Study Cooperative Agreement (U01) PAR-11-157


Why will U01 applications undergo peer-review if the multi-center clinical study has already been peer-reviewed as a part of the U34 Multi-Center Clinical Study Implementation Planning Grant?

​The peer-review of the U01 Multi-Center Clinical Study Cooperative Agreement will evaluate whether the proposed study remains scientifically important and feasible. During the multi-center clinical study planning of the U34 Multi-Center Clinical Study Implementation Planning Grant, changes in the study protocol may be necessary to accommodate advances in the scientific field. Furthermore, the rationale and/or significance of the proposed study may become obsolete. Therefore, peer-reviewers will be asked to re-evaluate the significance, innovation, approach, investigator and environment criteria as described above.


How long after submission of the U01 Multi-Center Clinical Study Cooperative Agreement will NIDDK take to review and make a funding decision?

​In order not to delay the initiation of the study, the peer review and award of a U01 grant will be completed within four months of the receipt of the U01 Multi-Center Clinical Study Cooperative Agreement application, when possible.