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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