SUPPLEMENTAL INSTRUCTIONS FOR RFA HL-04-001, CLINICAL RESEARCH CONSORTIUM TO IMPROVE RESUSCITATION OUTCOMES RELEASE DATE: August 8, 2003 NOTICE: NOT-HL-03-012 National Heart, Lung and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/) Institute of Circulatory and Respiratory Health (ICRH), Canadian Institutes of Health Research (CIHR) (http://www.cihr-irsc.gc.ca) 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 (https://grants.nih.gov/grants/guide/rfa-files/RFA-HL-04-001.html). 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; https://grants.nih.gov/grants/forms.htm), 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: http://www.nhlbi.nih.gov/funding/inits/resus_faq.htm.
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