# Data Coord Ctr-NICHD Cooperative Multicenter Maternal Medicine Units Research Net

> **NIH NIH U10** · GEORGE WASHINGTON UNIVERSITY · 2020 · $3,065,048

## Abstract

The Eunice Kennedy Srtr/Ver National Institute of Ciiiid Healtii and Hunnan Development Maternal-Fetal
Medicine Units (MFMU) Networl< was created in 1986 to conduct clinical researcti studies in obstetrics and
perinatal medicine. Tiie Networl< consists of a number of major academic clinical centers, a data
coordinating center, and tlie Institute itself. Tlie research) studies, principally randomized trials but also
observational studies, are aimed at reducing maternal, fetal and infant morbidity related to preterm birtti, fetal
growtli abnormalities and maternal complications and to provide ttie rationale for evidence-based, cost-
effective, obstetric practice.
Ttie data coordinating center is a critically important part of this collaborative effort. The overall purpose of
the coordinating center is to mal<e sure that the studies are designed to minimize bias, are conducted with
integrity, and the results analyzed and interpreted appropriately to ensure the validity of the conclusions. The
coordinating center is responsible for assisting the clinical investigators with developing the protocol, making
sure that regulations regarding protection of human subjects are followed, creating data forms and a manual
of procedures so that the data are collected accurately and training the clinical center staff to follow the
procedures. The coordinating center provides a data entry and management system and monitors the data,
as well as adherence to the protocol and retention of the study subjects. For randomized trials, the
coordinating center creates the randomization system, prepares interim reports for the independent Data and
Safety Monitoring Committee that is responsible for the safety of the patients on the trial, and reports for the
FDA, if that agency is overseeing a trial. The coordinating center conducts the final analysis of the data and
assists the clinical center investigators with the preparation of publications, and coordinates sharing of
datasets and resources per NIH policy. The coordinating center facilitates communication among the
centers and NIH, and provides a secure internal website for sharing information, in addition to arranging
meetings, conference calls and videoconferencing. Finally the coordinating center is in charge of obtaining
supplies and services, such as study drug and screening laboratories, necessary for the conduct of the
studies, and for making payments to the centers associated with recruitment and follow-up of the study
subjects.
RELEVANCE (See instructions):
The relevance ofthe proposed research to public health is clear and direct. The results ofthe MFMU
Network's studies can benefit potentially pregnant women and their children worldwide, by finding methods
to screen for problems in pregnancy, treatments that for pregnant women that improve their and their
children's health, and especially finding treatments that can help lessen the problem of babies being born too
early.

## Key facts

- **NIH application ID:** 10261684
- **Project number:** 3U10HD036801-22S1
- **Recipient organization:** GEORGE WASHINGTON UNIVERSITY
- **Principal Investigator:** Rebecca Gersnoviez Clifton
- **Activity code:** U10 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $3,065,048
- **Award type:** 3
- **Project period:** 1998-04-15 → 2021-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10261684

## Citation

> US National Institutes of Health, RePORTER application 10261684, Data Coord Ctr-NICHD Cooperative Multicenter Maternal Medicine Units Research Net (3U10HD036801-22S1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10261684. Licensed CC0.

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