Journal of Korean Medical Science, 2015, 01, S19─S24

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

최창원, 박문성

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.

• ISBN or ISSN: 1011-8934

• 본 연구는 질병관리본부 연구개발과제(과제번호 2013-E63008-01) 연구비를 지원받아 수행되었습니다.
• This research was supported by a fund(code 2013-E63008-01) by Research of Korea Centers for Disease Control and Prevention.