Evidence map›Paper›PMID 42173140›Full record

ArticleApplied clinical informatics2026

Enhancing Data Quality and Remote Accessibility in Clinical Trials: A SeroSelectTB Case Study in Ethiopia, Tanzania, and South Africa.

Sasho Najdov, Jordancho Arsov, Jovan Davchev, Tamirat Assefa, Jemrath Bikombo, Debora Kajeguka, Anna Okunola, Welile Nwamba, Aleksandar Josifoski, Carol Holm-Hansen

Erratum issuedAbstract read
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Article in Applied clinical informatics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Sasho NajdovAether Dynamics GmbH, Vienna, Austria.ORCID 0009-0007-5931-4687
Jordancho ArsovAether Dynamics GmbH, Vienna, Austria.
Jovan DavchevAether Dynamics GmbH, Vienna, Austria.
Tamirat AssefaArmauer Hansen Research Institute, Addis Ababa, Addis Ababa, Ethiopia.
Jemrath BikomboKilimanjaro Christian Medical Centre, Moshi Urban, Kilimanjaro Region, Tanzania, United Republic of.
Debora KajegukaKilimanjaro Christian Medical Centre, Moshi Urban, Kilimanjaro Region, Tanzania, United Republic of.
Anna OkunolaStellenbosch University Faculty of Medicine and Health Sciences, Cape Town, WC, South Africa.
Welile NwambaStellenbosch University Faculty of Medicine and Health Sciences, Cape Town, WC, South Africa.
Aleksandar JosifoskiAether Dynamics GmbH, Vienna, Austria.
Carol Holm-HansenNorwegian Institute of Public Health, Oslo, Oslo, Norway.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Ensuring data quality and maintaining remote accessibility remain key challenges in clinical trials conducted in low-resource settings. Although several software platforms and digital tools attempt to address these challenges, no single, comprehensive solution adequately meets the complex demands of decentralized and intermittently connected trial environments. Consequently, context-specific tools must be developed and adapted to ensure reliable performance under such constraints. Objective: The aim of this study was to enhance data quality and enable uninterrupted participant randomization in settings with limited internet and electricity through the implementation of an automated Quality Control (QC) reporting system and an online and offline participant randomization application. Methods: A centralized automated QC reporting system was developed using a Python-based script, which was integrated with the Research Electronic Data Capture system to extract and process data, and generate a web-based monitoring dashboard, which displayed data summaries, recruitment charts, and flags on missing or inconsistent records. Thereafter, a mobile randomization application built with React Native was developed for online and offline participant randomization, employing block randomization to ensure balanced allocation between study arms and enrollment continuity. Results: The automated QC system reduced data verification time from months to 1 hour, enabling real-time oversight and early error correction. The randomization application maintained balanced study arms and allowed uninterrupted participant enrollment during internet outages. These digital tools improved data completeness, reduced bias and human error, and increased trial efficiency across all study sites. Conclusion: Automation and offline functionality can significantly enhance data quality, efficiency, and integrity in clinical trials conducted in resource-constrained environments. The experience from this study demonstrates the value of combining automated QC and offline randomization tools to ensure robust and continuous study operations.

Indexed as

Clinical Trials as TopicData AccuracyDashboard SystemsEthiopiaHumansInternetQuality ControlSouth AfricaTanzania

Identifiers

PMID42173140
PMCPMC13287932

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.