1. Submitting clinical trial datasets and documentation for clinical outcome assessments using Item Response Theory: guidance for industry : technical specifications document Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, November 2023 Subject(s): Clinical Trials as TopicDrug DevelopmentDrug IndustryGovernment RegulationOutcome Assessment, Health CareUnited States
2. Submitting patient-reported outcome data in cancer clinical trials: guidance for industry : technical specifications document Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, November 2023 Subject(s): Clinical Trials as TopicDrug DevelopmentDrug IndustryGovernment RegulationNeoplasms -- drug therapyPatient Reported Outcome MeasuresUnited States