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NINDS Clinical Trial Planning Grant (R34)
Release Date: June 14, 2006
Announcement Number: PAR-06-460
Application Receipt Date:
August 18, 2006
December 18, 2006
April 18, 2007
August 20, 2007
December 18, 2007
April 18, 2008
August 18, 2008
December 18, 2008
April 20, 2009
Funding Contact: Scott Janis, Ph.D.
Program Area: Office of Clinical Research
Brief Description:
The NINDS seeks to fund high quality clinical trials to evaluate treatments for neurological disorders. This Funding Opportunity
Announcement (FOA) invites applications under the NINDS Clinical Trial Planning Grant Program, the purpose of which is to
provide support for the organization of activities critical for the successful implementation of high-risk, complex, or large-scale
clinical trials. The planning grant is intended to (a) allow for early peer review for the rationale and design of the proposed
clinical trial; (b) provide support for the development of a detailed manual of operations and procedures; and (c) provide
support to develop essential elements of a clinical trial, such as the development of tools for data management and oversight
of the research, the definition of recruitment strategies, the finalization of the protocol, analytical techniques, facilities,
administrative procedures, obtaining IND/IDE, and the establishment of collaborative arrangements. The purpose of the NINDS
planning grant is not to obtain preliminary data or to conduct pilot studies to support the rationale or the clinical trial.
The expected product of the planning grant is a detailed clinical trial research plan including a complete manual of operations
and procedures. Included in the planning grant application must be a completed study protocol and projected direct costs
for the future phase III trial.
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