ACRO member companies have compiled a series of case studies that demonstrate how centralized monitoring identifies critical issues more quickly and effectively than traditional on-site monitoring methods. This is the fourth post in a series highlighting centralized monitoring at work. Check back for more examples of how centralized monitoring has benefited ACRO member companies and their sponsor partners.
Case Study 4: Analysis Reveals Duplicate Participants
The data integrity analysis was conducted across all study sites and participants as part of centralized monitoring deliverables for a mega-sized Phase III women’s health trial (approximately 3,500 patients were enrolled). The analysis included a comparison of demographic details, vitals, medical history, concomitant medications, and electronic clinical outcome assessment (eCOA) device IDs across all participants in the study. Additionally, the analysis included a review of distance between the locations of sites to identify potential duplicate participants.
Roughly 60 participants were identified as potential duplicates. These participants were then further assessed, and the duplication was confirmed with input from the site and by the relevant clinical research associate (CRA). As a result of this review, any duplicate participants were discontinued and/or screen failed from the study.
This analysis was run on a regular cadence to support the CRAs in ongoing identification of potential duplicate participants. Without this in-depth centralized monitoring analysis, there is a strong likelihood that the CRA and others on the study team might not have been able to identify this duplication issue, potentially resulting in a serious data integrity issue. Centralized monitoring helped flag this issue quickly and was continually analyzed to mitigate it as the study enrollment continued.
Read the additional case studies in the Centralized Monitoring at Work series: