Discovery of Inadvertent mixture IP from other lot/study
Discovery:
9 mos months after FPI, Maieutics discovered that the pharmacy had mixed vials from this study with vials from two other trials using the same Investigational Product (IP). Eight pts were affected, with over 20 treatment cycles impacted.
Solution:
The issue was escalated to the Sponsor and traced back to a misstructured risk-based monitoring strategy. We recommended restructuring the risk matrix to ensure proper oversight. Additional site visits were immediately scheduled to conduct an in-depth review of the study until the new monitoring structure was approved and implemented.
Learning lesson and conclusion:
Using risk-based trials, oversight visits are essential to identify structural flaws that could compromise: Patient safety, Data integrity, Overall study viability. Our timely intervention prevented broader study errors caused by inadequate monitoring—preserving the trial’s integrity and continuity. Maieutics, in your future project, will conduct real-time assessments, including pharmacy oversight, to proactively prevent GCP noncompliance.