ERT's eC-SSRS is a cost-effective electronic version of the Columbia Suicide Severity Rating Scale, which assesses the occurence of treatment-related suicidal tendency in clinical trial participants.
The Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) facilitates compliance with the newly introduced Food and Drug Administration (FDA) guidance document entitled 'Suicidality: Prospective assessment of occurrence in clinical trials'.
The FDA guidance document is intended to assist sponsors in assessing the occurrence of treatment-related suicidality in clinical trials of drug and biological products.
It highlights the increasingly recognised importance of suicidality assessment in psychiatric and non-psychiatric drug trials and provides general principles for how best to achieve effective assessment during the drug development process.
The guidance intends to serve as a focus for continued discussions among the FDA, pharmaceutical sponsors, the academic community and the public.
ERT's electronic self-rated version of the C-SSRS was developed in collaboration with the scale authors and provides a cost-effective method of proactively monitoring suicidality for trial sponsors.
Using interactive voice-response technology validated against the C-SSRS, the eC-SSRS is a fully structured interview providing standardised questions, relevant follow-up questions, error-handling routines and scoring conventions.
Helping to facilitate the FDA requirements, the eC-SSRS enables timely identification of possible risks and supplies rapid feedback to study sites for evaluation and follow-up.
