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TECHNICAL SUPPORT FOR THE NATIONAL CHILDREN'S STUDY (NCS): DEVELOPMENT OF A QUALITY MANAGEMENT PLAN
Impact/Purpose:
The objective of this task is to provide the National Children's Study Program Office with a quality management plan that will delineate a systematic planning process for the implementation of the National Children's Study. The QMP is to state the goals and objectives of the NCS, the management structure, project schedules, resources, milestones, and requirements. The QMP is to identify the type of data and information the study requires, how and where this information will be obtained, the study's design, boundaries and constraints. The QMP is to describe the multidisciplinary effort for the NCS and identify all QA documents needed for its implementation. The QMP will identify the organizations and persons responsible for the development, implementation, oversight, and monitoring of the NCS quality assurance requirements.
Description:
The Children's Health Act of 2000 (PL 106-310) mandated the National Institute of Child Health and Human Development, (NICHD), the Environmental Protection Agency (EPA), and the Centers for Disease Control and Prevention (CDC), to jointly plan, develop, and conduct a prospective cohort study of the environmental influence on children's health and development, now known as the National Children's Study (NCS). Primary responsibility for the NCS is to lie with NICHD, with the EPA, CDC, and NIEHS partnership being delineated as agreed to with NICHD as the study progresses. The goals of this study are to address important medical, environmental, and social hypotheses concerning the effects of environmental exposure on children's physiology, emotional development, and cognitive abilities. For this study, environment is broadly defined to include biological, chemical, physical, social, and behavioral influences on children with the hope of better understanding the roles of these factors, alone or in combination, on children's health, disease and development. By linking a range of environmental factors to multiple health and developmental outcome measures, the NCS will help to pinpoint the root causes of many of todays major childhood diseases and disorders. The NCS will be national in scope and will involve the study of approximately 100,000 children from a point in time before birth through age 21; the study over the course of its 21 year lifespan is expected to cost between 2.3 and 2.7 billion dollars. To implement this Congressional mandate, an IAG commits NERL's Human Exposure and Atmospheric Sciences Division (HEASD) and NICHD to a cooperative partnership in planning and conducting the NCS study and the delineation of the expected role NERL's HEASD will play. HEASD is to assist NICHD with the planning, development, and implementation of this prospective cohort study including quality assurance oversight, focusing on quality assurance/quality control aspects. EPA will supply technical expertise and contract oversight to develop a comprehensive Quality Management Plan (QMP) for the National Children's Study (NCS) which will serve as the "umbrella" quality assurance document under which individual specific Quality Management Plans, Quality Assurance Project Plans (QAPP) and Standard Operating Procedures (SOP) will be developed and implemented. This QMP will address how specific quality assurance (QA) and quality control (QC) activities will be coordinated, integrated, and monitored over the course of the 21+ year study. This QMP should identify: individual QA documents that need to be developed over the course of this study, the timeline for their development, who is responsible for what, who reports to whom, and what procedures will be in place to assure the successful implementation of this QMP and it subsequent component QMPs, QAPPs and SOPs. This QMP will be developed in accordance with EPA Requirements for Quality Management Plans (QA/R-2) which can be found on the web at http://www.epa.gov/quality/qs-docs/r2-final.pdf The QMP will delineate a systematic planning process for the implementation of the National Children's Study. The QMP will state the goals and objectives of the NCS, the management structure, project schedules, resources, milestones, and requirements. The QMP is to identify the type of data and information the study requires, how and where this information will be obtained, the study's design, boundaries and constraints. The QMP is to describe the multidisciplinary effort for the NCS and identify all QA documents needed for its implementation. The QMP will identify the organizations and persons responsible for the development, implementation, oversight, and monitoring for NCS quality assurance.