FDA-adopted Columbia-Suicide Severity Rating Scale (C-SSRS) Categories for Prospective Assessment Improving Precision of Identification and S
Product Details
The FDA is concerned about suicidal thoughts and behaviors arising from — or compounded by — the use of investigational new drugs in clinical trials. In August, the agency issued a draft guidance with updated recommendations, including using the Columbia-Suicide Severity Rating Scale (C-SSRS). These improved data collection methods are of critical importance, as debunking false notions of risk and accurately identifying true risk are equally crucial from a public health perspective.
In this special encore presentation, the development team for the C-SSRS discusses their research, the FDA’s draft guidance and its implication and how to use the C-SSRS in multiple research settings.
Join Dr. Kelly Posner, Dr. John Greist, and Mike Federico in this 90-minute encore presentation. This is an expert panel you do not want to miss.
The FDA recommends proactive assessments of suicidal thought and behavior for any drug being developed for a psychiatric condition, for antiepileptic drugs and for other neurologic drugs with central nervous system activity. The new draft guidance states that C-SSRS screening questions should be posed to patients at the start of a study and repeated at every visit either by phone or electronically.
In this session, Dr. Posner, Dr. Greist and Mr. Federico will discuss:
- The FDA’s revision and rationale for the 2012 draft guidance and best implementation practices
- Clarify the Columbia-Suicide Severity Rating Scale (C-SSRS) 11 categories required by the guidance
- How a self-rated approach is part of an optimal response to draft guidance requirements
- How use of the C-SSRS reduces site and sponsor burden while providing predictive capability, and protecting compounds against the potential of false signals
- Optimal models of sponsor and study implementation guidance and policies will be reviewed
FDA-adopted Columbia-Suicide Severity Rating Scale (C-SSRS) Categories for Prospective Assessment is convenient to attend. All that’s required is that you be in front of a screen, whether you’re at the office or telecommuting from your office-at-home.
So spread the word. Learn how to manage this wild-card risk with these newly-developed best practices.