Case Study
ERT ELECTRONIC RATER TRAINING
ELECTRONIC SYSTEMS FOR =50% OF ALL DRUG APPROVALS SINCE 2013 106 LANGUAGES SUPPORTED IMPROVE THE QUALITY OF YOUR CLINICAL TRIAL DATA Uniform administration of assessments or completion of patient health status reports in clinical trials is required to reduce rater variability and minimize data risk with clinical outcome assessment implementations as well as to meet recommendations. Furthermore, effective assessment training remains a key determinant of whether a therapy attains efficacy and/or safety. The Food and Drug Administration (FDA), European Medicines Agency (EMA), and International Society for Pharmacoeconomics and Outcomes Research (ISPOR) recommend that site raters, patients and caregivers capturing assessment data receive training in the correct use of the instrum