The FDA has issued two technical specifications guidance documents titled, Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory and Submitting Patient-Reported Outcome Data in Cancer Clinical Trials. The documents provide recommendations to support the submission of complex data types: clinical outcome assessments that use item response theory and patient-reported outcome data collected in cancer clinical trials. Both guidance documents supplement the Patient-Focused Drug Development (PFDD) Guidance Series.
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