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Assessing the impact of risk-based data monitoring on outcomes for a paediatric multicentre randomised controlled trial.

Renate Le MarsneyKerry JohnsonJenipher Chumbes FloresShelley CoetzerJennifer DarvasCarmel DelzoppoArielle JollyKate MastersonClaire SherringHannah ThomsonEndrias ErgetuPatricia GilholmKristen S Gibbons
Published in: Clinical trials (London, England) (2024)
Targeted source data verification of data critical to trial outcomes, which carried with it a substantial time investment, did not have an impact on study outcomes in this trial. This evaluation of the cost-effectiveness of targeted source data verification contributes to the evidence-base regarding the context where reduced emphasis should be placed on source data verification as the foremost monitoring activity.
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