Rater Training
The Sponsor required all clinical trial sites to ensure all raters were qualified with a minimum of 5 years of psychometric assessment experience. Additionally, all Raters must be certified in MADRS administration specifically for this trial prior to performing clinical trial assessments. Rater training and certification is a multi-step process consisting of reviewing professional qualifications, years of clinical experience, bipolar disorder clinical trial diagnostic experience, and protocol-specific scale administration, including the total number of MADRS administrations and administrations within the past year.
Standardized training was provided for all ratings used in the trial, including MADRS, MINI, C-SSRS, which are used as key primary or secondary trial endpoints. Protocol-specific MINI training was administered via video by Dr. David Sheehan, the author and publisher of the MINI. MADRS training consisted of reviewing and scoring one (or more) test cases and achieving a minimum inter-rater or intra-class reliability correlation coefficient (or ‘IRR score’) of 0.80 or greater. IRR scores quantify the degree of Rater agreement on bipolar disorder ‘gold standard’ training case(s). Further, all Raters were certified in the administration of the C-SSRS by completing online training via the BlueCloud® system.