RFA-HD-14-020 – Data Coordinating Center for the Collaborative Pediatric Critical Care Research
Nomination per School: One
Proposals may not be submitted directly by the PI; nominations are submitted by the School’s Research Dean’s Office.
LOI: May 2, 2014
Internal Deadline: Contact the Office of Research if interested
External Deadline: June 2, 2014
Award Information: Type: New; Renewal
Estimated Number of Awards: NICHD intends to commit $2,500,000 in FY 2015 to fund one award.
Anticipated Amount: An applicant for the DCC may request a budget for direct costs up to $800,000 per year. In addition, the DCC should request not more than $1,300,000 total costs per year in the patient and protocol cost category for distribution to the Clinical Sites, and support for required monitoring and Data and Safety Monitoring Board (DSMB) visits, and Advisory Board support. An applicant for the DCC may request a project period of five years.
Materials to Office of Research: Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt.).
CV – (4 pages maximum)
The purpose of this FOA is to solicit applications for a centralized Data Coordinating Center (DCC) to support the activities of the Collaborative Pediatric Critical Care Research Network (CPCCRN). The funded DCC will cooperate with the NICHD CPCCRN Program Directors/Principal Investigators (PDs/PIs) and the NICHD Project Scientist in identifying research topics of high priority and in designing protocols appropriate to the evaluation of optimal management in these areas. The DCC will have primary responsibility for data management and analysis for Network research, in collaboration with the CPCCRN Steering Committee.
Objectives and Scope
In the third, presently competed cycle in this FOA, the DCC will support up to seven core Clinical Sites in clinical, translational, and descriptive research to investigate the safety and efficacy of treatment and management strategies in the care of critically ill children, and to carry out research in the pathophysiology and consequences of childhood critical illness and injury.
Applicants for the DCC should be familiar with RFA-HD-14-022 announcing the re-competition of the Collaborative Pediatric Critical Care Research Network Clinical Sites to learn more about the scope, structure, and functions of the CPCCRN.
The functions of the DCC will include developing protocol data management aspects, devising novel comparative study designs, providing sample size calculations and statistical advice, developing data forms and protocol tools, performing data analyses, administering scientific protocol funds for sites with NICHD approval/concurrence, coordinating and providing logistical support for the activities and meetings of the Steering Committee (four times a year, mostly in the Washington, DC area), Data and Safety Monitoring Board (as needed), Advisory Board (annually) and overall study coordination and quality assurance. While the DCC is not firmly required to have offices in the Washington, DC area, applications without such a resource should provide detailed documentation of how logistical support for the CPCCRN and its activities will be provided without an office in the Washington, DC area. Because of the nature of the Network, it is anticipated that a minimum PD/PI time commitment of 70% (8.4 person months) will be needed. Applications with differing leadership effort commitment plans should document in detail how Network needs will be met.
The Data Coordinating Center will:
- Provide expertise in the design, conduct, data analyses and data management of collaborative clinical and descriptive research projects.
- Coordinate multisite IRB submissions and documentation of approvals of CPCCRN studies.
- Use informatics and electronic data technologies to design and produce data collection systems; modify and re-design such systems as appropriate for new study protocols.
- Provide appropriate and capable leadership and expertise in biostatistics, developmental study design, data management, data analysis and project management. These activities should include, but are not limited to, staff and site training and quality assurance procedures.
- Provide research support activities in designing data collection modules, operational procedure manuals, quality control systems, and an internet-based communications system for Clinical Site PD/PIs, Research Coordinators, and other Network staff.
- Manage and distribute patient and protocol funds, after NICHD approval, to participating Clinical Sites on a per protocol capitation basis.
- Provide meeting and conference support for the activities of the Steering Committee, Advisory Board and DSMB through provision of materials and documentation, meeting planning and logistics, and conference call coordination.
- Organize and conduct multi-site monitoring activities in conjunction with the NICHD Project Scientist.
- Provide regular reports to NICHD on enrollment, diversity, and the allocation of resources.
- Respond appropriately to changing work needs, Network prioritization and re-prioritization, and changes in staffing.
- Provide administrative and scientific assistance in the preparation of manuscripts for publication to the Steering Committee of the CPCCRN, under the supervision of the NICHD Project Scientist.
- Provide exploration, technical expertise and management of novel resources to enhance network research. Examples might include (but are not limited to) establishment of a CPCCRN biorepository, if feasible within present resources, and establishment of semantic interoperability in electronic health records (EHRs) across the Network.
- Prepare and provide publicly utilizable data sets in accordance with NIH data sharing and open access policies.
- Establish a process for preparing and managing Investigational New Drugs (IND) and Investigational Device Exemption (IDE) reports and other regulatory requirements.
- Provide arrangements for data collection and reimbursement of study-related data collection costs at non-Network sites participating in Network studies.