eCOA SCIENCE BRIEF: 2017 GLOBAL REGULATORY & ISPOR GUIDANCE RATER TRAINING UPDATE 

Issues with patient, caregiver and/or site staff variability in reporting the COA/eCOA are a leading cause of data disparities. What’s the solution? The FDA, EMA and leading scientific authorities recommend assessment training for patients, caregivers and site staff

Download this 2017 update of current recommendations and guidelines for training within clinical trials. This Brief examines:

  • FDA & EMA PRO and eSource Guidances and Reflection Papers, and what steps you should take for improving data quality
  • Dedicated ISPOR Tasks Force reports that explain the criticality of training on both the trial and each assessment
  • 14 Therapeutic-specific Guidances on Rater Training issued within the last 2 years!