Looking beyond the numbers: quality assurance procedures in the Global Network for Women’s and Children’s Health Research Maternal Newborn Health Registry

Abstract

Background: Quality assurance (QA) is a process that should be an integral part of research to protect the rights and safety of study participants and to reduce the likelihood that the results are afected by bias in data collection. Most QA plans include processes related to study preparation and regulatory compliance, data collection, data analysis and publication of study results. However, little detailed information is available on the specifc procedures associated with QA processes to ensure high-quality data in multi-site studies. Methods: The Global Network for Women’s and Children’s Health Maternal Newborn Health Registy (MNHR) is a prospective population-based registry of pregnancies and deliveries that is carried out in 8 international sites. Since its inception, QA procedures have been utilized to ensure the quality of the data. More recently, a training and certifca‑ tion process was developed to ensure that standardized, scientifcally accurate clinical defnitions are used consist‑ ently across sites. Staf complete a web-based training module that reviews the MNHR study protocol, study forms and clinical defnitions developed by MNHR investigators and are certifed through a multiple choice examination prior to initiating study activities and every six months thereafter. A standardized procedure for supervision and evalu‑ ation of feld staf is carried out to ensure that research activites are conducted according to the protocol across all the MNHR sites. Conclusions: We developed standardized QA processes for training, certifcation and supervision of the MNHR, a multisite research registry. It is expected that these activities, together with ongoing QA processes, will help to further optimize data quality for this protocol.