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U01 Frequently Asked Questions

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

Introduction

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.


Application

What should I do if I want to submit a U01 Cooperative Agreement?

Applicants are strongly encouraged to contact the appropriate NIDDK Program Director to discuss their proposed application and to do so as soon as possible, preferably at least 12 weeks before the submission date. Program staff will help the investigator understand whether the proposed full clinical study addresses a high priority research area and meets programmatic needs including balance across research areas, whether it is appropriate to conduct using this mechanism, and whether funds might be available for the subsequent, full clinical study. See the NIDDK Research Areas to identify the correct program director for your application. If you are not sure of the appropriate program director, you can contact one of the program directors designated as contacts for information in the PAR (PAR-14-XXX) and you will be directed to the appropriate individual.


How far in advance of the U01 Cooperative Agreement application receipt date should I contact NIDDK?

​You should contact the appropriate Program Director at least 12 weeks before the desired receipt date. Since this is a cooperative agreement, NIDDK will ultimately have substantive scientific involvement with the proposed project. NIDDK will need sufficient time to thoroughly consider the proposed study. It is the Institute’s experience that applications for multi-center clinical studies may be scientifically meritorious but often need further work before they are ready for submission.  Allowing as much time as possible for the consultation process will allow time for revisions, should they need to be made.

Please remember that the consultation process is distinct from the NIH requirement that investigators requesting $500,000 or greater direct costs in any year (exclusive of consortium F&A) are required to have pre-approval to submit the application at least 6 weeks prior to the receipt date.
 


What information should be included in a letter requesting consultation about applying for a U01 Multi-Center Cooperative Agreement?

The details included in your letter may vary depending on the type of study planned (e.g., epidemiology study, drug trial, behavior intervention). Generally, the letter should include all of the following items:

  • Date of Proposed Submission
  • Study title
  • Study PI, and other key investigators (attach biosketch(es)) 
  • Primary institution 
  • Specific aims 
  • Significance 
  • Summary of study protocol, including flow diagram depicting study 
  • Summary of safety/risk issues 
  • Proposed start date, duration, and timeline of the clinical trial 
  • Proposed sample size including power calculation 
  • General statistical assumptions for the proposed study design and analysis 
  • Confirmed collaborating sites, including the demographics and availability of the study population at those sites. Include identification and a brief description of the Data Coordinating Center
  • Discussion of product/intervention to be evaluated and how it will be obtained, if applicable, including industry partner(s) and regulatory issues that have/need to be resolved
  • Detailed budget by year
  • Evidence that the U34 planning components have been completed


Who should I contact for prior consultation?

​You should contact the appropriate program director for the subject matter of the application. See the NIDDK Research Areas to identify the correct program director for your application.  If you are not sure of the appropriate program director, you can contact one of the program directors designated as contacts for information in the PAR and you will be directed to the appropriate individual (PAR-14-XXX).


U01 Peer Review

If the U34 is appropriately productive (e.g., protocol finalization, manual of operations development), will a U01 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-14-XXX NIDDK Multi-Center Clinical Study Cooperative Agreement (U01).


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 Cooperative Agreement?

​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 Cooperative Agreement, 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.