‘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