ADDENDUM: TYPE 1 DIABETES TRIALNET: CLINICAL CENTERS (RFA-DK-01-003) Release Date: February 2, 2001 NOTICE: NOT-DK-01-006 National Institute of Diabetes, and Digestive and Kidney Diseases The purpose of this addendum is to inform potential applicants of changes to RFA-DK-01-003, Type 1 Diabetes TrialNet: Clinical Centers. This RFA appeared in the October 5, 2000 issue of the NIH Guide for Grants and Contracts and can be accessed at the following URL: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-01-003.html. All changes to the RFA text are related to an additional allowable investigator position that can be requested at up to 10% effort to supplement the expertise of the Principal Investigator. The addition of this position is commensurate with the multi-disciplinary approach of these projects, which will bring together researchers with expertise in immunology, endocrinology, and clinical trial design and implementation. The Principal Investigator for a clinical center application may not have expertise in all of these areas and may wish to include another investigator in the application who can provide complementary expertise. The following sections of the RFA are modified to allow for the addition of an additional investigator, at up to 10% effort: 1. FUNDS AVAILABLE Approximately $4.8 million in total costs per year will be committed to provide personnel and supplies to the Clinical Centers in order to complete DPT-1 and initiate planning for future studies conducted within the Type 1 Diabetes TrialNet, with a cap of approximately $242,000 per clinical center per year in total costs. 2. APPLICATION PROCEDURES: Additional Materials to Include in the Application, Qualifications and experience It is important to establish the Principal Investigator’s and any additional investigator’s ability to contribute to the scientific agenda and describe an adequate time commitment of the Principal Investigator (5-20%), additional investigator (up to 10%), Trial Coordinator (100%), and Recruitment Coordinator (50%). 3. Budget Information For the Clinical center component, applicants should request support for a Principal Investigator at 0.5-0.20 FTE, an additional investigator (if needed) up to 0.10 FTE, a Trial Coordinator at 1 FTE (preferably a nurse or certified diabetes educator), and a Recruitment Coordinator at 0.5 FTE. Other Sections of the RFA Throughout the RFA, there is reference to the staff of each Clinical Center consisting of the Principal Investigator, a Trial Coordinator, and a Recruitment Coordinator. The staff can now include the Principal Investigator, another investigator up to 10% effort, a Trial Coordinator, and a Recruitment Coordinator. The additional investigator may serve on the Steering Committee and take part in other Study Committees as necessary. All other sections of the RFA remain unchanged. INQUIRIES Inquiries are encouraged, and the opportunity to clarify issues and answer questions is welcome. Inquiries may be directed to: Catherine C. Cowie, PhD Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd, Rm 691, MSC 5460 Bethesda, MD 20892-5460 Telephone: (301) 594-8804 FAX: (301) 480-3503


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