RELEASE DATE:  August 8, 2003

NOTICE:  NOT-HL-03-012

National Heart, Lung and Blood Institute (NHLBI)
National Institute of Neurological Disorders and Stroke (NINDS)
Institute of Circulatory and Respiratory Health (ICRH), 
Canadian Institutes of Health Research (CIHR)

This Notice contains supplemental instructions for preparing the Research Plan 
as part of a Regional Clinical Center Application for RFA HL-04-001, Clinical 
Research Consortium to Improve Resuscitation Outcomes 

Each Regional Clinical Center applicant should propose a research plan that 
includes two protocols.  One protocol must focus on cardiopulmonary arrest, and 
the other on trauma.  These protocols must be short-term (12-18 months) clinical 
trials and must also involve sufficient subjects to require the use of a 
network with multicenter participation.  The research plan should follow the 
instructions in the PHS 398 application form (revised 5/2001;, and should 
include: a one page overview of the proposed investigations that presents the 
key research objective of each investigation and a diagram depicting the 
initiation and duration of the two investigations; a description of each of the 
protocols that includes the rationale, research aims, outcome measures, and 
study design (including a statistical plan and sample size calculations); a 
description of the patient populations with an estimate of the expected 
distribution of minority and female patients; and assurances of the applicant's 
access to the patient populations.
The applicant should indicate for each of the two protocols how many patients 
are available in the applicant's center and how many will be required for the 
entire Consortium. In the discussion of outcome measures, it will be important 
to indicate appropriate objective measures of primary and secondary outcomes. 
Items a-d of the Research Plan, including protocols, must not exceed 25 pages as 
specified in the PHS 398 instructions.

In addition, the potential role of key personnel in specific protocols should be 
identified.  The applications are encourage to explore, in the context of the 
proposed protocols, new technologies that could lead to improved treatments, 
monitoring, predicting or evaluating response to therapy.  The protocol should 
include strategies to assure adherence to therapy. 

Additional guidance on Frequently Asked Questions may be found at:

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