ArticleBritish journal of clinical pharmacology2019
Impact of a targeted monitoring on data-quality and data-management workload of randomized controlled trials: A prospective comparative study.
Article in British journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.
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Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Monitoring strategies for clinical intervention studies.The Cochrane database of systematic reviews · 2021Pooled it
- PROSPECT-LUNG: A National Clinical Trials Network Trial Advancing Pragmatic Innovation in Cancer Clinical Trials.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2026Trial
- Systematic data capture reduces the need for source data verification: exploratory analysis from a phase 2 multicenter randomized controlled platform trial.Communications medicine · 2025Article
- A risk-based monitoring approach to source data monitoring and documenting monitoring findings.Contemporary clinical trials · 2024Article
- Source Data Verification (SDV) quality in clinical research: A scoping review.Journal of clinical and translational science · 2024Article
- Monitoring metrics over time: Why clinical trialists need to systematically collect site performance metrics.Research methods in medicine & health sciences · 2023Article
- Article
- Using systematic data categorisation to quantify the types of data collected in clinical trials: the DataCat project.Trials · 2020Article
- Impact of a targeted monitoring on data-quality and data-management workload of randomized controlled trials: A prospective comparative study.British journal of clinical pharmacology · 2019Article
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsMonitoring risk-based approaches in clinical trials are encouraged by regulatory guidance. However, the impact of a targeted source data verification (SDV) on data-management (DM) workload and on final data quality needs to be addressed.
methodsMONITORING was a prospective study aiming at comparing full SDV (100% of data verified for all patients) and targeted SDV (only key data verified for all patients) followed by the same DM program (detecting missing data and checking consistency) on final data quality, global workload and staffing costs.
resultsIn all, 137 008 data including 18 124 key data were collected for 126 patients from 6 clinical trials. Compared to the final database obtained using the full SDV monitoring process, the final database obtained using the targeted SDV monitoring process had a residual error rate of 1.47% (95% confidence interval, 1.41-1.53%) on overall data and 0.78% (95% confidence interval, 0.65-0.91%) on key data. There were nearly 4 times more queries per study with targeted SDV than with full SDV (mean ± standard deviation: 132 ± 101 vs 34 ± 26; P = .03). For a handling time of 15 minutes per query, the global workload of the targeted SDV monitoring strategy remained below that of the full SDV monitoring strategy. From 25 minutes per query it was above, increasing progressively to represent a 50% increase for 45 minutes per query.
conclusionTargeted SDV monitoring is accompanied by increased workload for DM, which allows to obtain a small proportion of remaining errors on key data (<1%), but may substantially increase trial costs.
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