Standardized study performance, quality assurance, and quality control in a cluster-randomized trial: the Pneumococcal Vaccine Schedules trial.

ABSTRACT: Randomized controlled trials are considered the "gold standard" for evaluating the effectiveness of an intervention. However, large-scale, cluster-randomized trials are complex and costly to implement. The generation of accurate, reliable, and high-quality data is essential to ensure the validity and generalizability of findings. Robust quality assurance and quality control procedures are important to optimize and validate the quality, accuracy, and reliability of trial data. To date, few studies have reported on study procedures to assess and optimize data integrity during the implementation of large cluster-randomized trials. The dearth of literature on these methods of trial implementation may contribute to questions about the quality of data collected in clinical trials. Trial protocol

SUBMITTER: Osei I 

PROVIDER: S-EPMC11654193 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature