Determining the extent and frequency of on-site monitoring: a bayesian risk-based approach.

ABSTRACT:

Background

On-site monitoring is a crucial component of quality control in clinical trials. However, many cast doubt on its cost-effectiveness due to various issues, such as a lack of monitoring focus that could assist in prioritizing limited resources during a site visit. Consequently, an increasing number of trial sponsors are implementing a hybrid monitoring strategy that combines on-site monitoring with centralised monitoring. One of the primary objectives of centralised monitoring, as stated in the clinical trial guidelines, is to guide and adjust the extent and frequency of on-site monitoring. Quality tolerance limits (QTLs) introduced in ICH E6(R2) and thresholds proposed by TransCelerate Biopharma are two existing approaches for achieving this objective at the trial- and si

SUBMITTER: Xie L 

PROVIDER: S-EPMC11212185 | biostudies-literature | 2024 Jun

REPOSITORIES: biostudies-literature