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.