ERT C-SSRS SUICIDE RISK ASSESSMENT
ERT C-SSRS SUICIDE RISK ASSESSMENT
2 PagesGOLD-STANDARD SIB ASSESSMENT ELECTRONIC SYSTEMS FOR =50% OF ALL DRUG APPROVALS SINCE 2013 ENSURE PATIENT SAFETY WITH EFFECTIVE EVALUATION OF SUICIDAL IDEATION AND BEHAVIORS Treatment-emergent suicidal ideation and behaviors (SIB) threaten efficacy and patient safety. The FDA’s latest guidance on SIB in clinical trials recommends prospective assessment for a wide variety of indications, especially psychiatric and central nervous system drug trials. 1 The Columbia-Suicide Severity Rating Scale (C-SSRS) is the gold standard for assessing SIB, and the FDA considers the instrument and electronic C-SSRS implementation as a suitable instrument to deliver the expected level of data quality. Electronic data collection of SIB presents many benefits over paper collection, including impr
