Suicidal Ideation And Behavior (SIB) Monitoring

The emergence of suicidal thoughts and behavior during treatment can jeopardize the effectiveness of the treatment and the safety of the patient. In clinical trials, the FDA recommends that SIB be prospectively evaluated for a wide range of indications, particularly those involving the central nervous system and psychiatric drugs.

To assess SIB, the Columbia-Suicide Severity Rating Scale (C-SSRS) is considered the gold standard, and the FDA approves both the instrument and electronic versions of the C-SSRS as suitable for obtaining high-quality data.

The use of electronic data collection for SIB offers several advantages over paper-based methods, such as better signal detection and data quality, reduced data noise due to missing or illegible entries, and access to real-time reporting and safety alerts. Learn how patient self-rated and clinician interview options for electronically implementing the C-SSRS can facilitate trial workflow, improve data quality, and increase patient safety.