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 affected 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 specific 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 certifica‑
tion process was developed to ensure that standardized, scientifically accurate clinical definitions are used consist‑
ently across sites. Staff complete a web‑based training module that reviews the MNHR study protocol, study forms
and clinical definitions developed by MNHR investigators and are certified through a multiple choice examination
prior to initiating study activities and every six months thereafter. A standardized procedure for supervision and evalu‑
ation of field staff 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, certification 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.