Issue Date: November 6, 2023
Issued by: Center for Drug Evaluation and Research
Topic(s):
Status: Final
Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory
This document provides technical specifications for the submission of clinical outcome assessment (COA) data that use Item Response Theory (IRT) and supplements the FDA Center for Drug Evaluation and Research (CDER) Patient-Focused Drug Development (PFDD) Methodological Guidance Series. As described in the Biomarkers, EndpointS, and other Tools (BEST) Resource glossary, a COA refers to the assessment of a clinical outcome made through a report by a clinician, a patient, a non-clinician observer, or through a performance-based assessment; thus, there are four types of COAs: clinician-reported outcome (ClinRO), patientreported outcome (PRO), observer-reported outcome (ObsRO), and performance outcome (PerfO) measures.
Download the Guidance Document
