Quality Assurance Assessment of the National Children's Study (NCS) Vanguard Study

The scientific accuracy and rigor of the National Children’s Study (NCS) Vanguard study (VS) was of paramount importance to protecting human participants and their data, and for achieving the overarching scientific goals of the NCS.  A quality assurance assessment (QAA) was developed and implemented to support this objective.  The overall objective of the QAA was to ensure the standardization of data collection procedures and the consistency of VS data, from original observations through reporting of results.  The QAA was implemented across the NCS Regional Operations Centers (ROC), which conducted data collection for the study, and their associated study locations. 

 While there is sufficient literature on quality improvement models for clinical trials, there is a lack of information on quality improvement models for longitudinal studies. This poster has two objectives.  First, it explains the conceptual framework and the design of the NCS VS QAA as it related to quality improvement. This framework is built on the Total Quality Management (TQM) philosophy and consists of two essential components, quality assurance (QA) and quality control (QC).  Based on this framework, quality assessment indicators and measures were developed to determine the extent to which policies, procedures, and requirements on quality were fulfilled by the ROCs and the study locations. Secondly, the successes and challenges associated with implementation of the QAA and the lessons learned are described. These lessons are useful to other longitudinal studies in maternal and child health, especially in assessing quality of biometric and physical measures data collection.