Regulatory Expectations Regarding KRIs
Regulatory Expectations Regarding KRIs What Do Regulatory Authorities Expect from Your KRI Framework? Introduction: KRIs in the Eyes of Regulators As Risk-Based Monitoring (RBM) becomes standard practice in clinical trials, the use of Key Risk Indicators (KRIs) has drawn the attention of regulators worldwide. Whether it’s the FDA, EMA, or PMDA, authorities want assurance that…