Firstcall/ERT has announced an electronic self-rated version of the Columbia Suicide Severity Rating Scale (C-SSRS) to facilitate compliance with regulatory requirements for suicidal monitoring.
The eC-SSRS uses interactive voice-response technology that has been validated against the C-SSRS.
It is a fully structured C-SSRS interview comprised of standardised questions, appropriate follow-up questions, error-handling routines and scoring conventions.
Similar to the C-SSRS, the eC-SSRS assesses lifetime suicidality during an initial baseline evaluation and then monitors ideations and behaviours at subsequent study visits.
This solution allows for timely identification of potential risks and provides prompt feedback to study sites for follow-up and evaluation.
The C-SSRS has been identified by the FDA as the only acceptable assessment instrument currently available for monitoring suicidal ideations and behaviours in clinical trials.
The eC-SSRS has been used in a validation study sponsored by a major pharmaceutical company, using psychiatric in-patients and healthy control volunteers.
The results demonstrated convergent validity of the eC-SSRS with the Beck Suicide Scale.
In addition, inter-rater reliability between the eC-SSRS and human C-SSRS raters was comparable to reliabilities found between the human raters.
The study also demonstrated good criterion validity of the eC-SSRS for discriminating known-groups differences between the study samples.
Overall, the eC-SSRS displayed its feasibility, reliability and validity for assessing suicidality prospectively.
The eC-SSRS is now supporting several ongoing clinical trials in large and mid-sized pharmaceutical companies.
