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U01 Multi-center Clinical Studies

Research Project Cooperative Agreements

The information on this page applies specifically to applicants applying for support for multi-center clinical studies as described in PAR-11-157.  All other applicants should refer to the NIH U01 guidelines
 
NIDDK supports 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

This policy applies to all clinical studies, interventional trials as well as observational studies, conducted at three or more sites.

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.
 
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.
 

How to Apply

Most applicants will have had a U34 before applying for a U01.  If you are seeking an exemption from the U34 requirement and wish to submit a multi-center clinical study cooperative agreement (U01) application (PAR-11-157​), you should send a written request for permission to submit to the appropriate program director. Program staff will determine whether all the components of the U34 planning period have been accomplished and whether an exemption from the U34 is appropriate. Staff will also help the investigator understand whether the proposed 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 full clinical study.
 
You should contact the appropriate Program Director at least 6 weeks before the desired receipt date. However, to take the best advantage of the prior consultation process, contact should be initiated as soon as possible. Since this is a cooperative agreement, NIDDK will 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. Allotting more than 6 weeks for the consultation process will allow time for revisions, should they need to be made.
 
Your written request for approval should be as succinct as possible. 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.
More detailed instructions regarding the U01 application process are contained in the following program announcement: PAR-11-157
 

The U01 at the NIDDK

NIDDK will not accept applications for multi-center clinical studies that are submitted as R01s, with the exception of ancillary studies to existing cooperative agreements, which can be submitted as R01s to PAR-12-265, Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01), or applications submitted in response to other future FOAs. This policy does not apply to pilot studies. Investigators who are interested in obtaining support for pilot studies may use the R21 mechanism, through the appropriate program announcement:

View U01 and other Current Funding Opportunities