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

Ana Garces, Emily MacGuire, Holly L. Franklin, Norma Alfaro, Gustavo Arroyo, Lester Figueroa, Shivaprasad S. Goudar, Sarah Saleem, Fabian Esamai, Archana Patel, Elwyn Chomba, Antoinette Tshefu, Rashidul Haque, Jacquelyn K. Patterson, Edward A. Liechty, Richard J. Derman, Waldemar A. Carlo, William Petri, Marion Elizabeth M. Koso-ThomasMcClure, Robert L. GoldenbergPatricia Hibberd, Nancy F. Krebs

Research output: Contribution to journalArticlepeer-review

6 Citations (Scopus)


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.

Original languageEnglish
Article number159
JournalReproductive Health
Publication statusPublished - Nov 2020


  • Adult learning
  • Global network
  • Public health training
  • Quality assurance
  • Quality control
  • Training for research studies


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