Notice Number: NOT-DK-07-015
Update: The following update relating to this announcement has been issued:
- December 11, 2014 - See Notice NOT-DK-14-025. Clarification of NIDDK Policy: Investigator-Initiated Multi-Center Clinical Studies.
- July 3, 2013 - See Notice NOT-DK-13-013. Clarification of NIDDK Policy: Investigator-Initiated Multi-Center Clinical Studies.
- May 18, 2010 - See Notice NOT-DK-10-003 Clarification of NIDDK Policy.
Key Dates
Release Date: October 18, 2007
Issued by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/)
This notice informs potential applicants of changes in NIDDK policies and procedures for the acceptance, peer review, and funding of investigator-initiated, multi-center clinical studies.
NIDDK will support 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.
Multi-Center Clinical Study Implementation Planning (U34) Grant
Beginning with the March 19, 2008 application receipt date, NIDDK will support implementation planning (U34) grants for multi-center clinical studies. The U34 is a cooperative agreement award mechanism, with the NIH staff being substantially involved as a partner with the Principal Investigator. The U34 is designed to provide early peer review of the rationale and design of the proposed clinical study and to support all administrative study group activities that are required in order to begin recruitment of subjects. These activities include, but are not limited to: establishing the research team, developing the tools for data management and oversight of the research, defining the recruitment strategies, finalizing the protocol and investigators brochure, writing the Manual of Operations, establishing a data and safety monitoring plan and initiating the IRB approval process. The U34 is not designed for the collection of preliminary data, for the conduct of pilot studies to support the rationale for a clinical study, or for the design of the study. The U34 application will include the proposed study design.
All multi-center clinical studies must complete this two-part process. The U34 grant will provide up to two years of support. Pre-approval from NIDDK will be required for submission of an U34 application. U34 applications will be peer reviewed by special emphasis panels set up by the NIDDK Review Branch.
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.
Multi-Center Clinical Study Grant (U01)
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. An exemption may be requested by investigators who believe that they completed all the steps which would normally be conducted during the U34. 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.
More detailed instructions regarding the multi-center clinical study application process will be contained in two PARs, one for the Multi-Center Clinical Study Implementation planning (U34) Grant and one for the Multi-Center Clinical Study Grant (U01), which will be published in the Guide in the future.
Inquiries
Inquiries concerning investigator-initiated, multi-center clinical studies should be sent to:
Barbara Linder, M.D., Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 699
6707 Democracy Boulevard
Bethesda , MD 20892-5460
Telephone: (301) 594-0021
Fax: (301) 480-3503
Email: [email protected]
Catherine Meyers, M.D.
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 641
6707 Democracy Boulevard
Bethesda , MD 20892-5458
Telephone: (301) 451-4901
Fax: (301) 480-3510
Email: [email protected]
Patricia Robuck, Ph.D.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 659
6707 Democracy Boulevard
Bethesda , MD 20892-5450
Telephone: (301) 594-8872
Fax: (301) 480-8300
Email: [email protected]
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