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GUIDANCE DOCUMENT

Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory November 2023

Download the Final Guidance Document
Final Level 2 Guidance
Docket Number:
FDA-2018-D-1216
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-1216.

 
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