Risk-based monitoring focuses on adapting the frequency and intensity of on-site visits based on data quality and site performance. If the data is consistently accurate and reliable, the monitoring frequency may be reduced. Conversely, if issues are identified, more frequent monitoring may be necessary.
GCP guidelines emphasize a flexible approach to monitoring, allowing adjustments based on the risk profile and quality of data collected.
"Risk-based monitoring involves adapting the frequency of on-site visits according to the quality of the data and the site's compliance level."
Objectives:
Implement a dynamic monitoring strategy.
Enhance efficiency while maintaining data integrity.
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