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. 2023 Mar:126:107110.
doi: 10.1016/j.cct.2023.107110. Epub 2023 Feb 3.

Informatics infrastructure in a rural pediatric clinical trials network: Matching specific clinical research needs with best practices and industry guidelines

Melody Greer  1 , Maryam Y Garza  1 , Jeannette Lee  2 , Fred Prior  1 , Lawrence Tarbox  1 , Jeff Tobler  1 , Anita Walden  3 , Meredith Nahm Zozus  4 , Jessica Snowden  5
Affiliations

Informatics infrastructure in a rural pediatric clinical trials network: Matching specific clinical research needs with best practices and industry guidelines

Melody Greer et al. Contemp Clin Trials. 2023 Mar.

Abstract

Children have historically been underrepresented in randomized controlled trials and multi-center studies. This is particularly true for children who reside in rural and underserved areas. Conducting multi-center trials in rural areas presents unique informatics challenges. These challenges call for increased attention towards informatics infrastructure and the need for development and application of sound informatics approaches to the collection, processing, and management of data for clinical studies. By modifying existing local infrastructure and utilizing open source tools, we have been able to successfully deploy a multi-site data coordinating and operations center. We report our implementation decisions for data collection and management for the IDeA States Pediatric Clinical Trial Network (ISPCTN) based on the functionality needed for the ISPCTN, our synthesis of the extant literature in data collection and management methodology, and Good Clinical Data Management Practices.

Keywords: Clinical research networks; Clinical trials; Data quality; Informatics; Information use.

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Conflict of interest statement

Declaration of Competing Interest The authors have no competing interests to declare.

Figures

Figure 1.
Figure 1.
DCOC multisite clinical trial support system architecture
Figure 1.
Figure 1.
DCOC multisite clinical trial support system architecture
Figure 2.
Figure 2.
The ISPCTN Web Portal Researcher Dashboard with access points for individual study EDCs and research support information.
See this image and copyright information in PMC

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