BOSTON & GENEVA--(BUSINESS WIRE)--PHT Corporation announced the availability of the clinical version of the C-SSRS on the SitePad tablet, enabling clinicians and study staff to electronically assess suicidal ideation and behavior in clinical trial participants. PHT is the leading provider of technologies used to collect patient-driven eData for clinical research.
The rater version of the C-SSRS assessment is a semi-structured interview intended for administration by clinicians or study staff during clinical visits. It assesses suicidality. The digital version of the rater version of the C-SSRS on the SitePad tablet was developed in collaboration with the scale’s lead author Kelly Posner, PhD and ERT, the license holder of all digital versions of the C-SSRS including the self-reported eC-SSRS. PHT President and CEO Philip Lee said, “Having this instrument available for sponsors will facilitate their compliance with regulatory requirements for assessment of suicidal ideation and behavior.”
According to the FDA Guidance for Industry on Suicidal Ideation and Behavior, prospectively assessing suicidal ideation and behavior in clinical trials is to ensure that patients in clinical trials are properly recognized and adequately treated; and to ensure the collection of more timely and more complete data for pooled analyses. Suicide.org claims that almost 2% of worldwide deaths are suicides, and that global suicide rates have increased 60% in the past 45 years.
Dr. Susan M. Dallabrida explained, “Use of the rater version of the C-SSRS digitally on a SitePad tablet is advantageous over completion on paper which has demonstrated to be prone to transcription errors, data discrepancies and delayed analysis. Electronic programming provides raters with extensive edit checks, applies edge conditions and configures sub- and aggregate-scoring and calculations which bring discordant data capture to the attention of the rater in real time to enable error correction. Clinical research is facilitated with the rater version of the C-SSRS on the PHT SitePad tablet.”
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