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U01 Research Project Cooperative Agreement

The information on this page is for applicants seeking support for multi-center clinical studies as described in PAR-15-067.  All other applicants should refer to the NIH U01 guidelines.  

The NIDDK supports investigator-initiated, multi-center clinical studies through a two part process:

  1. an implementation planning phase (U34), 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 centers. 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 but all interventions and/or outcomes assessments are performed by a single study team.

U01 Frequently Asked Questions
Overview of Human Subjects Research at the NIDDK

U01 at the NIDDK

Proposed studies should be hypothesis-driven and focus on a disease relevant to the mission of NIDDK. Proposals are expected to improve understanding, diagnosis, prevention or treatment of the disease being studied.

How to Apply

Only Apply for a U01 if Your Planning Phase is Complete

Most applicants will have had a U34 before applying for a U01. Planning activities are not permitted as part of the U01 application. Investigators who require a planning phase should first apply for an implementation cooperative agreement (U34). Applicants who feel they have completed all the planning elements without a U34 may apply directly for the U01.

Read the Program Announcement

More detailed instructions regarding the U01 application process are contained in the following program announcement: PAR-15-067

Contact Program Staff At Least 12 Weeks Prior to Submission

All applicants, regardless of whether you hold a U34, are strongly encouraged to contact NIDDK program staff at least 12 weeks before submitting a U01 application. Program staff will 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.

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. Allowing as much time as possible for the consultation process will allow time for revisions, should they need to be made. 

Include Appropriate Details in Your Letter

Your written request for prior consultation 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 partners and regulatory issues that have/need to be resolved
  • Detailed budget by year.
  • Evidence that the U34 planning components have been completed.

Seek Pre-approval for Requests of $500,000 or More

Applicants are reminded that NIH requires pre-approval of applications requesting $500,000 or more in direct costs (excluding consortium facilities and administrative costs (F&A)) in any year. This preapproval process is distinct from prior consultation.

Consider Other Funding Mechanisms: R01 and R21

The 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-16-034: 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 that specifically invite multi-center clinical studies. 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 open R21 FOAs from NIDDK.