Author:
Garces Ana,MacGuire Emily,Franklin Holly L.,Alfaro Norma,Arroyo Gustavo,Figueroa Lester,Goudar Shivaprasad S.,Saleem Sarah,Esamai Fabian,Patel Archana,Chomba Elwyn,Tshefu Antoinette,Haque Rashidul,Patterson Jacquelyn K.,Liechty Edward A.,Derman Richard J.,Carlo Waldemar A.,Petri William,Koso-ThomasMcClure Marion Elizabeth M.,Goldenberg Robert L.,Hibberd Patricia,Krebs Nancy F.
Abstract
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 certification process was developed to ensure that standardized, scientifically accurate clinical definitions are used consistently 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 evaluation 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.
Funder
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Publisher
Springer Science and Business Media LLC
Subject
Obstetrics and Gynaecology,Reproductive Medicine
Cited by
6 articles.
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