Deployed widely in both clinical practice and clinical research, the C-SSRS is a powerful screening tool that assesses the full range of evidence-based suicidal ideation and behavior items, and provides criteria for next steps. This valuable tool is recommended by numerous international agencies and is available in 100+ languages. The C-SSRS is currently the only approved scale that meets the FDA Draft Guidance for Prospective Assessment of Suicidal Ideation and Behavior. It is a semi-structured assessment intended for administration by clinicians or study staff during scheduled study visits. It explores suicidal ideation and intensity, as well as behaviors and lethality. The FDA guidance specifically cites the (C-SSRS) as an acceptable instrument for prospectively assessing SIB in clinical trials. The C-SSRS directly maps to and populates the 11 SIB (formerly C-CASA) categories.
C-SSRS Deployment Options
There are multiple options available for the deployment of the C-SSRS in clinical trials. These include:
- Traditional paper-based, interview-style assessment performed by site personnel or designated mental health professional.
- Digital C-SSRS. Also conducted by site personnel or designated mental health professionals, this electronic version removes the manual processes and double-data entry associated with the paper C-SSRS. This is implemented on tablet technology using ERT’s AVERT™ platform.
- eC-SSRS. An electronic, fully structured, patient self-reported version of the C-SSRS. Available in tablet, IVR and web versions and deployed via ERT’s AVERT platform.