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- Published online September 27, 2021.
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- previous version (February 19, 2021 - 05:13).
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© PDA, Inc. 2021
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- Article
- Abstract
- Introduction
- Determination of Action and Alert Levels Based on Historical Data
- Rationale for Using Percentile Method to Determine Action and Alert Levels
- Definition of Adverse Trends
- Determination of Adverse Trends in Quarterly and Annual Trend Analyses
- Determination of Adverse Trends at the Onset of an Excursion Result
- Type I and Type II Errors
- Trend Rules Based on Binomial Probability
- Ongoing Processes
- Mature Processes
- Intermediate Processes
- New Processes
- Handling of Adverse Trends
- Case Study
- Recommendations for Implementation
- Sample Trend Charts
- Discussion
- Conclusion
- Conflict of Interest Declaration
- References
- Figures & Data
- References
- Info & Metrics
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