Key Findings • Improper or lack of association among Adverse Events (AEs), Concomitant Medications and Medical History pose a risk to obtaining a clear study endpoint. • Sponsors should review how the associations are designed, managed and enforce in the study. Recommendations Use an EDC system that allows for linkage between AEs and Concomitant medications. What You Need To Know When dealing with complex and multiple data associations between AEs and Concomitant Medicat

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