National Institutes of Health

NINDS: Stroke Trials Network - National Data Management Center (U01)

Program Summary

The purpose of this funding opportunity announcement (FOA) is to invite applications to participate as a National Data Management Center for the NINDS Stroke Trials Network.  Separate FOAs have been issued to solicit applications for the Regional Coordinating Stroke Centers (RFA-NS-13-011) and the National Clinical Coordinating Center (RFA-NS-13-012).  The primary goal of this network is to maximize efficiencies to develop, promote and conduct high-quality, multi-site exploratory phase 1/2 and confirmatory phase 3 clinical trials focused on key interventions, as well as biomarker-validation studies that are immediately preparatory to trials, in stroke prevention, treatment, and recovery with the objective to have a balanced portfolio between all three approaches.  The network will include multiple regional coordinating stroke centers around the U.S. representing a larger number of community stroke centers all coordinated through separate National Clinical Coordinating and Data Management Centers. 
 
A number of efficiencies will be encouraged through the network, including the sharing of clinical data and other collected biomarkers, such as neuroimaging.  The National Data Center for the network will be responsible for centralizing, harmonizing and coordinating all aspects of data collection for studies conducted in the network.  Projects will be developed both from investigators within the network as well as from investigators or industry partners outside of the network; therefore the data center for the stroke network must be able to efficiently collaborate with all parties.  The Network will also be uniquely poised to rapidly collaborate with other existing networks, such as the NINDS Neurological Emergencies Treatment Trials Network (NETT) or international consortia to conduct larger, definitive trials of promising interventions for the treatment of stroke.
 
Eligibility
 
Only one DMC application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed. 
 
Awards for a DMC and a RCC may be made to the same institution.  However, it is expected that the DMC and the RCC grants at a given institution be led by separate PD(s)/PI(s) and preferably in different departments or distinctly separate locations within the institution.

Award Information

NIH intends to fund one (1) award under this FOA, corresponding to a total of $1,125,000, for fiscal year 2014.  The expected direct cost for individual awards is up to $750,000 per project year.  The project period is limited to 5 years. 

Internal Selection Procedure
 
The Office of the Vice President for Research and the Carver Collge of Medicine have established an internal review procedure to select the UI nominee. Applications will be reviewed according to the sponsor's selection criteria. Consideration will also be given to UI institutional strengths and strategic directions. Potential applicants must submit, using the preselection link below, the following information:
1. A two page CV
2. A description of the proposed project. It should have the following elements:
  1. Additional pages may be added for references
  2. Please be sure the project is identified on each page and number the pages.
The above materials must be submitted no later than 5:00 p.m. on Wednesday, June 19, 2013. The selected nominee will be asked to complete the full application package in accordance with the sponsor's deadline of Monday, July 1, 2013.

Proposal due for preselection06/19/2013 Not open for submission deadline passed
Date Due to Sponsor07/01/2013
Required LOI Due DateN/A
Non-Required LOI Due Date07/01/2013
Email:angie-robertson@uiowa.edu
Phone:319-353-3619
Sponsor URL:http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-13-016.html

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