# Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory – FDA Guidance

Source: https://www.keypedia.com/guidances/guidance-document/submitting-clinical-trial-datasets-and-documentation-for-clinical-outcome-assessments-using-item-response-theory/9895a301-585a-4b74-83a1-3b526f3ec3d3

> FDA guidance document: Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory. Issue date: November 06, 2023. Get complete insights and analysis.

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## Details

- Title: Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory
- Communication Type: Guidance Document
- Product Type: other
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2023-11-06
- Last Changed: 2023-11-06
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2018-D-1216">FDA-2018-D-1216</a>

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