DEADLINE IS FRIDAY, MAY 19 AT NOON
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) invites applications from institutions willing to participate as the Data Coordinating Center (DCC) for the NICHD Neonatal Research Network (NRN) under a cooperative agreement in an ongoing multicenter clinical research program designed to perform interventional and observational clinical studies in newborn infants, particularly low birth weight infants. The objective of this program is to facilitate the advancement of neonatal care by establishing a network of academic centers that, by rigorous patient evaluation using common protocols, can study the required numbers of patients and provide answers more rapidly than individual centers acting alone.
The NRN infrastructure is set up for carefully designed randomized double-blinded placebo controlled as well as management trials with the ability to follow both short-term (clinical effect) and long-term (neurodevelopmental outcome) measures. The infrastructure is also set up for observational, longitudinal studies in the neonatal intensive care unit setting. Many randomized clinical trials involve the need for baseline information regarding disease incidence and outcome, which is available from the generic database of neonates <29 weeks gestation in the current NRN.
The NICHD NRN's mission is to investigate the safety and efficacy of treatment and management strategies for newborn infants. The clinical centers for the network were re-competed in 2015, and 15 clinical centers were awarded for the 2016-2021 cycle. The DCC plays a pivotal role in data management and analysis, statistical expertise, and logistical services required for the NRN. In support of the activities of the NRN, the DCC will:
(1) Collaborate in the development, implementation, and monitoring of common Network protocols;
(2) Provide data management and quality control with respect to data, preparation of data and safety reports for the Data and Safety Monitoring Committee (DSMC), and preparation of data reports for Network subcommittees, centers, and public data repositories. These include preparation of agenda, setting up meeting dates and times, inviting members, setting up call lines, taking minutes, preparing the minutes of the meetings, summarizing the details of the meetings and decisions made, maintaining and saving such official records as appropriate, and related activities.
(3) Collaborate in data analysis and publication of results of NRN trials and studies;
(4) Provide the logistical support necessary to run an efficient and productive network, including managing capitation funding to the clinical centers for infants enrolled in the Network studies; the DCC may coordinate external services, including procuring study drugs, equipment, and other supplies, implementing masking and randomization methods, and executing subcontracts, such as for conducting diagnostic tests for specific studies and consultancy agreements with outside experts.
(5) Collect and document all Institutional Review Board (IRB) reports and communications.
A responsive application must provide strong evidence of the applicant’s ability to cooperate with multiple sites involved in clinical trials in design, execution, data collection, and data analysis resulting in publication for multicenter randomized and observational clinical trials, particularly in the area of neonatal-perinatal medicine. The DCC must provide logistical support for meetings, teleconferences, and the steering committee. These include preparation of agenda, setting up meeting dates and times, inviting members, setting up call lines, taking minutes, preparing the minutes of the meetings, summarizing the details of the meetings and decisions made, maintaining and saving such official records as appropriate, and related activities.
University is limited to one proposal.
|UIC Letter of Intent||
May 19, 2017
|UIC Internal Competition||
|Sponsor Letter of Intent||
June 30, 2017
Letter of Intent
DUE TO THE QUICKLY APPROACHING DEADLINE, IN ADDITION TO THE ONLINE LOI PLEASE ATTACH A BRIEF OVERVIEW OF THE FOLLOWING (ONE PAGE LIMIT). DEADLINE IS NOON, FRIDAY MAY 19
- Aims and objectives
- Staffing Plan
- Management Plan
- Evidence of successful past performance
- Special strengths and expertise
Please contact Natalia Glubisz at RDS@uic.edu or 312-996-8348 with any questions.
If an authorized principal investigator is not listed above, please consider the limited competition still open. Contact RDS@uic.edu for further information.