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STATUS REPORT, BEGIN TO DEVELOP COMPLETE OPERATIONS MANUALS FOR THE COHORT: PREPARE TO IMPLEMENT A COHORT STUDY OF CHILDREN'S ENVIRONMENTAL HEALTH
MENDOLA, P. AND S. MYERS. STATUS REPORT, BEGIN TO DEVELOP COMPLETE OPERATIONS MANUALS FOR THE COHORT: PREPARE TO IMPLEMENT A COHORT STUDY OF CHILDREN'S ENVIRONMENTAL HEALTH. U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-05/016, 2005.
To provide an update on the development of an operations manual for the North Carolina Cohort Study, a precursor to the National Children's Study
As a precursor to the National Children's Study (NCS), the North Carolina Cohort Study (NC Cohort Study) will provide the opportunity to field test procedures to better inform the implementation of the NCS. In order to test some of the study hypotheses, it will be important to obtain both pre- and postconception measures of exposure. The NC Cohort Study will enroll 5,000 women who are either
pregnant or planning to become pregnant, and follow the children born to them. This demonstration cohort will allow for testing both traditional and emerging technologies to recruit and survey these women and their families, as well as utilizing various methods to ensure high retention rates throughout< the study. The experiences gained in the recruitment and data and biological specimen collection of the NC Cohort will inform these procedures for the NCS. In order to be able to successfully plan, coordinate, and implement such a complex study, RTI staff will work closely with U.S. EPA to identify any supplemental materials and identify any gaps that need further development before specific study materials can be developed. The purpose of this task is to
begin to assemble materials from the Program Office and other NCS reports that will be useful in the development of the OMB and IRB applications and operations manuals, and to identify the specific types of manuals that are likely to be required first for the NC Cohort Study, then for the NCS. This document identifies the current status of the preparations for materials to be developed.