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

Choi CW, Park MS - J. Korean Med. Sci. (2015)

Bottom Line: We describe the processes and results of DM and SVM performed during the establishment stage of the registry.Each participating hospital was visited biannually.Our experience with DM and SVM can be applied for similar multi-center registries with large numbers of participating centers.

View Article: PubMed Central - PubMed

Affiliation: Department of Pediatrics, Seoul National University College of Medicine, Seoul, Korea. ; Department of Pediatrics, Seoul National University Bundang Hospital, Seongnam, Korea.

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.

No MeSH data available.


Related in: MedlinePlus

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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Figure 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.

Mentions: SVM included visit site selection, SVM team organization, confirmation of research-related documents, identification of unregistered cases, source document verification, and post-visit report production. A total of 55 hospitals had participated in the KNN registry across the country by March 31, 2015. Participating hospitals with more than five registered VLBW infants were subject to SVM. For SVM, an SVM team was organized by dividing the country into the Seoul metropolitan area and six provinces (Fig. 2). In the first half of the registry period, the SVM team consisted of CRAs at headquarters hospital and PIs at participating hospitals located in the Seoul metropolitan area. However, for the second half of the registry period, PIs at participating hospitals in each province joined the SVM team and participated in SVM in their province. All participating hospitals were visited biannually. One or two PIs and one CRA visited one or two hospitals at a time. During SVM, institutional review board (IRB) approval status, informed consents, investigator files, and the e-CRF were checked. The most crucial parts of SVM were the identification of unregistered cases and source document verification. Unregistered cases were identified by comparing the number of VLBW infants admitted to the hospital with the number of created IDs in the e-CRF during a certain period of time. If unregistered cases were found, the reasons for omission were documented. Source documents were electronic medical records at most of the participating hospitals. Five to ten percent of the registered cases (at least five cases) were randomly selected and verified for any differences in 23 predetermined clinical variables between the medical records and e-CRF. After SVM, follow-up letters reporting the results of the site-visit and a corrective action request form were sent to the PI of the hospital by the CRA who conducted the SVM. The requested corrective action was to be completed and the corrective action request form signed and answered by the PI at the hospital within one month after the SVM. The CRA who performed the site-visit confirmed the receipt of the corrective action request form and provided feedback to the PI at the hospital visited.


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

Choi CW, Park MS - J. Korean Med. Sci. (2015)

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.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4641058&req=5

Figure 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.
Mentions: SVM included visit site selection, SVM team organization, confirmation of research-related documents, identification of unregistered cases, source document verification, and post-visit report production. A total of 55 hospitals had participated in the KNN registry across the country by March 31, 2015. Participating hospitals with more than five registered VLBW infants were subject to SVM. For SVM, an SVM team was organized by dividing the country into the Seoul metropolitan area and six provinces (Fig. 2). In the first half of the registry period, the SVM team consisted of CRAs at headquarters hospital and PIs at participating hospitals located in the Seoul metropolitan area. However, for the second half of the registry period, PIs at participating hospitals in each province joined the SVM team and participated in SVM in their province. All participating hospitals were visited biannually. One or two PIs and one CRA visited one or two hospitals at a time. During SVM, institutional review board (IRB) approval status, informed consents, investigator files, and the e-CRF were checked. The most crucial parts of SVM were the identification of unregistered cases and source document verification. Unregistered cases were identified by comparing the number of VLBW infants admitted to the hospital with the number of created IDs in the e-CRF during a certain period of time. If unregistered cases were found, the reasons for omission were documented. Source documents were electronic medical records at most of the participating hospitals. Five to ten percent of the registered cases (at least five cases) were randomly selected and verified for any differences in 23 predetermined clinical variables between the medical records and e-CRF. After SVM, follow-up letters reporting the results of the site-visit and a corrective action request form were sent to the PI of the hospital by the CRA who conducted the SVM. The requested corrective action was to be completed and the corrective action request form signed and answered by the PI at the hospital within one month after the SVM. The CRA who performed the site-visit confirmed the receipt of the corrective action request form and provided feedback to the PI at the hospital visited.

Bottom Line: We describe the processes and results of DM and SVM performed during the establishment stage of the registry.Each participating hospital was visited biannually.Our experience with DM and SVM can be applied for similar multi-center registries with large numbers of participating centers.

View Article: PubMed Central - PubMed

Affiliation: Department of Pediatrics, Seoul National University College of Medicine, Seoul, Korea. ; Department of Pediatrics, Seoul National University Bundang Hospital, Seongnam, Korea.

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.

No MeSH data available.


Related in: MedlinePlus