RESUMO
BACKGROUND: Risk-based quality management is a regulatory-recommended approach to manage risk in a clinical trial. A key element of this strategy is to conduct risk-based monitoring to detect potential risks to critical data and processes earlier. However, there are limited publicly available tools to perform the analytics required for this purpose. Good Statistical Monitoring is a new open-source solution developed to help address this need. METHODS: A team of statisticians, data scientists, clinicians, data managers, clinical operations, regulatory, and quality compliance staff collaborated to design Good Statistical Monitoring, an R package, to flexibly and efficiently implement end-to-end analyses of key risks. The package currently supports the mapping of clinical trial data from a variety of formats, evaluation of 12 key risk indicators, interactive visualization of analysis results, and creation of standardized reports. RESULTS: The Good Statistical Monitoring package is freely available on GitHub and empowers clinical study teams to proactively monitor key risks. It employs a modular workflow to perform risk assessments that can be customized by replacing any workflow component with a study-specific alternative. Results can be exported to other clinical systems or can be viewed as an interactive report to facilitate follow-up risk mitigation. Rigorous testing and qualification are performed as part of each release to ensure package quality. CONCLUSIONS: Good Statistical Monitoring is an open-source solution designed to enable clinical study teams to implement statistical monitoring of critical risks, as part of a comprehensive risk-based quality management strategy.
RESUMO
While emotion coherence has long been theorized to be a core feature of emotion, to date, studies examining response coherence have been conducted in laboratory settings. The present study used a combined approach of ambulatory physiology measures and ecological momentary assessment conducted over a 4-week period to examine the extent to which emotional experience and physiology show coherence in daily life within-persons; and whether individual differences in response coherence are associated with between-person differences in well-being, negative emotionality, and gender. Results revealed that, on average, individuals exhibited coherence between subjective experience and physiology of emotion, but that there was substantial between-person variation in coherence in daily life. Exploratory analyses revealed no credible link between levels of response coherence and well-being, negative emotionality, or gender. Findings contribute to the literature by demonstrating a novel methodological approach to measuring coherence in daily life and supporting the generalizability of coherence to ecologically valid contexts.
