RTI International (RTI), a trade name for Research Triangle Institute, proposes to become the Data Coordinating and Analysis Center (DCAC) for NICHD's """"""""Research on the Scope and Causes of Stillbirth in the United States"""""""" network. RTrs twenty-nine years of experience serving as DCAC for a vadety of multisite clinical and behavioral studies, many in the field of maternal and child health, enable us to recognize the various responsibilities that must be undertaken by a DCAC to successfully meet the ever changing needs of a multisite study. These responsibilities include, but are not limited to: (1) participating in protocol development, (2) developing and implementing a study-wide communications network, (3) providing sophisticated data collection and management systems that are responsive to the emerging needs of the study, (4) supporting the logistics of the study as needed, (5) assisting in training site personnel in standard study procedures, (6) assisting in developing and implementing quality control and quality assurance procedures, (7) providing biostatistical and data management leadership, (8) producing both routine and ad hoc reports that meet the needs of the Clinical Sites, NICHD, the Steering Committee, the Advisory Committee and the Data Safety and Monitoring Committee, and (9) helping to disseminate the results of the study through publications and presentations. The key staff proposed for the project, Dr. Corette Parker, PI, and Dr. Matthew Koch, Co-PI, are both senior biostatisticians with supporting programs in epidemiology. They each have over 15 years experience managing DCAC activities and leading statistical tasks for multisite studies. Dr. Koch's medical degree provides an additional badge between the statistical and medical components of the network. As the demands of the network change, we will be able to supplement our base staff with needed expertise from our large staff with vaded backgrounds that address the anticipated needs of the study. RTI' office next door to NICHD in Rockville, MD provides meeting space as needed for interaction with NICHD staff. During the first year of the project, RTI will collaborate with NICHD and the Steering Committee to develop the study protocol with particular input into statistical design and analysis, data capture methods, data management and processing, quality control, and training of site data collection and data management staff.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01HD045954-05S1
Application #
7639067
Study Section
Special Emphasis Panel (ZHD1-MCHG-B (25))
Program Officer
Willinger, Marian
Project Start
2003-09-26
Project End
2014-01-31
Budget Start
2008-08-01
Budget End
2014-01-31
Support Year
5
Fiscal Year
2008
Total Cost
$1,393,438
Indirect Cost
Name
Research Triangle Institute
Department
Type
DUNS #
004868105
City
Research Triangle
State
NC
Country
United States
Zip Code
27709
Page, Jessica M; Thorsten, Vanessa; Reddy, Uma M et al. (2018) Potentially Preventable Stillbirth in a Diverse U.S. Cohort. Obstet Gynecol 131:336-343
Freedman, Alexa A; Kipling, Lauren M; Labgold, Katie et al. (2018) Comparison of diameter-based and image-based measures of surface area from gross placental pathology for use in epidemiologic studies. Placenta 69:82-85
Harrison, Margo S; Thorsten, Vanessa R; Dudley, Donald J et al. (2018) Stillbirth, Inflammatory Markers, and Obesity: Results from the Stillbirth Collaborative Research Network. Am J Perinatol 35:1071-1078
Angley, Meghan; Thorsten, Vanessa R; Drews-Botsch, Carolyn et al. (2018) Association of participation in a supplemental nutrition program with stillbirth by race, ethnicity, and maternal characteristics. BMC Pregnancy Childbirth 18:306
Gibbins, Karen J; Gibson-Corley, Katherine N; Brown, Ashley S et al. (2018) Effects of excess thromboxane A2 on placental development and nutrient transporters in a Mus musculus model of fetal growth restriction. Biol Reprod 98:695-704
Gibbins, Karen J; Reddy, Uma M; Saade, George R et al. (2018) Smith-Lemli-Opitz Mutations in Unexplained Stillbirths. Am J Perinatol 35:936-939
Freedman, Alexa A; Cammack, Alison L; Temple, Jeff R et al. (2017) Maternal exposure to childhood maltreatment and risk of stillbirth. Ann Epidemiol 27:459-465.e2
Page, Jessica M; Christiansen-Lindquist, Lauren; Thorsten, Vanessa et al. (2017) Diagnostic Tests for Evaluation of Stillbirth: Results From the Stillbirth Collaborative Research Network. Obstet Gynecol 129:699-706
Boyle, Annelee; Preslar, Jessica P; Hogue, Carol J R et al. (2017) Route of Delivery in Women With Stillbirth: Results From the Stillbirth Collaborative Research Network. Obstet Gynecol 129:693-698
Christiansen-Lindquist, Lauren; Silver, Robert M; Parker, Corette B et al. (2017) Fetal death certificate data quality: a tale of two U.S. counties. Ann Epidemiol 27:466-471.e2

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