SIREN Clinical Center Awards (blue)
- Duke University
- Johns Hopkins Medicine
- Medical College of Wisconsin
- Oregon Health and Science University
- Temple University
- University of California, Davis
- University of California, Los Angeles
- University of Chicago
- University of Cincinnati
- University of Minnesota
- University of Pittsburgh
- University of Washington
- Virginia Commonwealth University
- Wayne State University
- Yale University
Coordinating Centers (red)
Clinical Coordinating Center (CCC)
University of Michigan
The CCC creates the SIREN Network infrastructure to promote and conduct clinical trials for patients with neurologic, cardiac, respiratory and hematologic emergencies by identifying effective treatments given in the earliest stages of care by:
- Developing the Network architecture and organizational structure including bylaws and procedures.
- Establishing processes to design and implement trials that will encourage the clinical translation of findings into routine practice.
- Managing clinical trials (establish rigorous criteria for monitoring recruitment, adhere to established deadlines and develop criteria for monitoring Hub effectiveness and compliance).
- Providing clinical trial operational resources (electronic data entry, automated screening and notification, access to telemedicine resources, advanced outcomes assessment, and human subjects protection tools).
- Creating an information technology infrastructure that will enhance the efficiency, speed, and accuracy of site, trial, and data management in the Network.
- Establishing trial development structures (recruit future trials and investigators, define internal review and publication procedures).
The CCC engages clinicians in the clinical research mission and provides the training and professional development to ensure effective clinical trial participation by:
- Recruiting and maintaining study sites and participants.
- Educating and training investigators, study coordinators and other research staff.
- Ensuring ongoing quality improvement of research processes.
- Organizing and conducting Phase III clinical trials that address important therapeutic questions and demonstrate the capabilities of the Network.
Multiple PIs:
Bill Barsan (University of Michigan)
Clifton Callaway (University of Pittsburgh)
Robert Silbergleit (University of Michigan)
Data Coordinating Center (DCC)
Medical University of South Carolina
The Data Coordination Unit (DCU) at the Medical University of South Carolina serves as the SIREN DCC and is well-poised to successfully collaborate with the SIREN infrastructure and provide high-quality, reliable and innovative support for the multicenter trials conducted in SIREN. The DCC provides a comprehensive data management and statistical infrastructure to support the Network’s goal of conducting high quality clinical trials that will improve outcomes for patients with neurologic, cardiac, respiratory, hematologic, and trauma emergency events. Key activities include:
- Close collaboration with the CCC, federal partners and Hubs
- Develop and maintain the Clinical Trials Management System (CTMS) that is used by the Network (referred to as WebDCU™).
- Contribute to the rapid and reliable dissemination of trial-specific information needed by the various stakeholders.
- Oversee all data management activities, including system user training, CRF development, data verification, quality assurance, and quality control.
- Collaborate with individual study teams on the development and maintenance of study-related documents, WebDCU™ modules, and a comprehensive risk-based monitoring plan.
- Provide statistical resources for the design and analysis of trials.
- Provide statistical reporting for Data and Safety Monitoring Boards.
The DCC engages clinicians and their research teams in the clinical research mission and provides the training and professional development to ensure effective clinical trial participation by:
- Educating and training investigators, study coordinators and other research staff.
- Ensuring ongoing quality improvement of research processes.
- Organizing and conducting clinical trials that address important therapeutic questions and demonstrate the capabilities of the Network.
Multiple PIs: Valerie Durkalski-Mauldin and Sharon Yeatts
Co-Is: Wenle Zhao and Catherine Dillon
Operations Lead: Sara Butler
Information Systems Lead: Keith Pauls