‘Real Time’ Psychometric Rating Review
A ‘Master Rater’ with an average of 20 years of clinical research experience in the neuropsychiatry therapeutic area supervised and reviewed psychometric scale administrations of all site raters (MK or IRS). Each Master Rater listened to digital audio recordings of the Site Rater’s interviews and provided an independent assessment without knowing the site rater’s assigned score. The Rating Review Plan calls for 100% review of all MINI, MADRS, and C-SSRS data at Screening, for all new Sites and new Raters—with a 24- to 48-hour review time. The initial plan was to randomly review 50% of MADRS site ratings between midpoint and endpoints; however, NRx Rater Program Managers increased the review rate to 100% to ensure data reliability across all assessments. This process of continuous monitoring and review of concordance rates is intended to produce valid and reliable assessments, and reduce rater inflation, drift, or fatigue over time.12