Coordinating Center for Organ Transplant Clinical Trials

Document Type:	Grants Notice
Funding Opportunity Number:	RFA-AI-04-046
Posted Date:	Oct 05, 2004
Original Due Date for Applications:	Jan 11, 2005
Current Due Date for Applications:	Jan 11, 2005
Archive Date:	Feb 10, 2005
Funding Instrument Type:	Cooperative Agreement
Category of Funding Activity:	Health
Expected Number of Awards:	1
Estimated Total Program Funding:	$3,000,000.00
Award Ceiling:	none
Award Floor:	none
CFDA Number:	93.856 -- Microbiology and Infectious Diseases Research 93.855 -- Allergy, Immunology and Transplantation Research
Cost Sharing or Matching Requirement:	No

Eligible Applicants

Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education

Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education

For profit organizations other than small businesses

Small businesses

Public and State controlled institutions of higher education

Private institutions of higher education

State governments

County governments

City or township governments

Special district governments

Independent school districts

Native American tribal governments (Federally recognized)

Public housing authorities/Indian housing authorities

Native American tribal organizations (other than Federally recognized tribal governments)

Others (see text field entitled "Additional Information on Eligibility" for clarification)

Additional Information on Eligibility:

Eligible agencies of the Federal Government are eligible to apply.
Foreign institutions are not eligible to apply as the primary institution, but may enter into a consortium or subcontract with a domestic institution as the primary applicant.

Agency Name

Description

This initiative will establish a Statistical and Clinical Coordinating Center (SACCC) to support clinical studies in organ transplantation to be conducted by two NIAID-sponsored clinical consortia, the Clinical Trials in Organ Transplantation (CTOT) Consortium and the Cooperative Clinical Trials in Pediatric Transplantation (CCTPT) Consortium. NIAID intends to commit approximately $3 million in FY 2005 to fund one new grant in response to this RFA. This RFA will use the NIH cooperative agreement (U01) funding mechanism. Eligible organizations include for-profit or non-profit organizations; public or private institutions, such as universities, colleges, hospitals, and laboratories; units of State and local governments; and eligible agencies of the Federal government. Foreign institutions are not eligible to apply. The applicant organization must have special expertise in clinical trial design, including approaches to the study of small and/or heterogene!
ous patient populations; organ or tissue transplantation; implementation of multi-center clinical trials; clinical research involving vulnerable populations; and established procedures for monitoring of clinical research sites. In addition, it must have the facilities necessary for electronic data submission and data management; tracking and distribution of study medications and samples; and secure storage of regulatory and clinical documents. Eligible principal investigators include any individual with the skills, knowledge, and resources necessary to carry out the proposed research. The Principal Investigator must have appropriate expertise and capability in biostatistics, data management, data analysis, and project management, and must possess a doctoral degree in an appropriate field. Submit one application per applicant. Application materials available at http://grants.nih.gov/grants/forms.htm

Link to Full Announcement

http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-04-046.html

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