J Korean Med Sci.  2015 Oct;30(Suppl 1):S19-S24. 10.3346/jkms.2015.30.S1.S19.

Data Management and Site-Visit Monitoring of the Multi-Center Registry in the Korean Neonatal Network

• Choi CW
• Park MS

• KMID: 2351132
• DOI: http://doi.org/10.3346/jkms.2015.30.S1.S19

Abstract

The Korean Neonatal Network (KNN), a nationwide prospective registry of very-low-birth-weight (VLBW, < 1,500 g at birth) infants, was launched in April 2013. Data management (DM) and site-visit monitoring (SVM) were crucial in ensuring the quality of the data collected from 55 participating hospitals across the country on 116 clinical variables. We describe the processes and results of DM and SVM performed during the establishment stage of the registry. The DM procedure included automated proof checks, electronic data validation, query creation, query resolution, and revalidation of the corrected data. SVM included SVM team organization, identification of unregistered cases, source document verification, and post-visit report production. By March 31, 2015, 4,063 VLBW infants were registered and 1,693 queries were produced. Of these, 1,629 queries were resolved and 64 queries remain unresolved. By November 28, 2014, 52 participating hospitals were visited, with 136 site-visits completed since April 2013. Each participating hospital was visited biannually. DM and SVM were performed to ensure the quality of the data collected for the KNN registry. Our experience with DM and SVM can be applied for similar multi-center registries with large numbers of participating centers.

Keyword

Clinical Data Management; Site-Visit Monitoring; Prospective Registry; Multi-Center Study

MeSH Terms

Data Collection
Hospitals
Humans
Infant, Newborn
Infant, Very Low Birth Weight
*Registries
Republic of Korea
Societies, Medical/*organization & administration
Support Vector Machine

Figure

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  Fig. 1 A schematic outline of the Korean Neonatal Network data management process. PI, principal investigator; CRC, clinical research coordinator; DM, data management team.

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  Fig. 2 The regional distribution of the participating hospitals. Fifty-two hospitals were visited since April 2013. The 61.5% of the hospitals were located in the Seoul metropolitan area. The numbers in the parentheses indicate the population of each province. M, millions.

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  Fig. 3 The cumulative numbers of very-low-birth infants registered in each year since April 2013.

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  Fig. 4 The result of query management of the Korean Neonatal Network as of March 31, 2015. A reconfirm error occurs when a query was created but the data was confirmed as correct.

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  Fig. 5 Site-visit monitoring performed in the fifty two participating hospitals across the country. By November 28, 2014, 52 participating hospitals had been visited. A total of 42 personnel, including three clinical research associates at the headquarters hospital and 39 principal investigators at the participating hospitals contributed to site-visit monitoring since April 2013.

Reference

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