What is ClinSafe Monitor?

ClinSafe Monitor is an enterprise-level R Shiny application for clinical trial adverse event (AE) analysis and pharmacovigilance signal detection. It reads CDISC-standard ADaM datasets (ADSL and ADAE) and provides interactive safety dashboards for clinical teams, biostatisticians, and safety reviewers.

Built with: R Shiny, bslib, plotly, reactable, DT, survival, dplyr, openxlsx. Deployed on managed infrastructure with systemd + nginx.

Overview Tab

The Overview tab shows headline safety metrics: total subjects, total AEs, SAEs, fatalities, and AEs by treatment arm. Use the sidebar filters to narrow by arm, grade, or seriousness. The SOC bar chart shows incidence rates side by side. The grade pie shows distribution.

AE Explorer

Interactive table of all ADAE records. Filter by System Organ Class (SOC) and relatedness. Grade is colour-coded (green=1, yellow=2, orange=3, red=4). Download as CSV using the button.

Signal Detection (Pharmacovigilance)

• PRR (Proportional Reporting Ratio): Ratio of the AE rate in the drug arm to the AE rate in the control arm. PRR >= 2 with n >= 3 and Chi-squared >= 4 is a regulatory signal threshold (Evans 2001).
• ROR (Reporting Odds Ratio): Similar to OR from a 2x2 table. More stable than PRR for rare events.
• Chi-squared: Tests statistical independence. >= 4 (p~0.05) supports a signal.
• SIGNAL: All three thresholds met — requires immediate review.
• WATCH: PRR >= 1.5 — elevated, monitoring recommended.

Time Trends

AE onset by week for both arms, Kaplan-Meier time-to-first-AE curve (survival analysis), and a stacked SOC/grade breakdown.

Subject View

Select any subject to see their full AE narrative as a Gantt-style timeline. Each bar shows the AE duration, coloured by grade. The table below shows full ADAE detail.

Data Disclaimer

DUMMY DATA ONLY. All subjects and events are synthetically generated following CDISC ADaM standards. No real patient data is used. This application is a demonstration of R Shiny capabilities.