# Submitting Patient-Reported Outcome Data in Cancer Clinical Trials - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/submitting-patient-reported-outcome-data-in-cancer-clinical-trials/cdd19350-5c19-44b6-9812-51398fa0fc71

> FDA guidance document: Submitting Patient-Reported Outcome Data in Cancer Clinical Trials. Issue date: November 06, 2023. Get complete insights and analysis.

---

## Details

- Title: Submitting Patient-Reported Outcome Data in Cancer Clinical Trials
- Communication Type: Guidance Document
- Product Type: drugs
- 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: 2023-11-03
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2018-D-1216">FDA-2018-D-1216</a>

## Related Documents

- [Submitting Continuous Glucose Monitoring Data in Clinical Trials](https://www.globalkeysolutions.net/guidances/guidance-document/submitting-continuous-glucose-monitoring-data-in-clinical-trials/242cfeef-dde5-46f4-b50e-9669a5a75ca9)
- [Technical Specifications for Submitting Clinical Trial Data Sets for Response Assessments for Treatments of Acute Leukemias:  Guidance for Industry Technical Specifications Document](https://www.globalkeysolutions.net/guidances/guidance-document/technical-specifications-for-submitting-clinical-trial-data-sets-for-response-assessments-for-treatments-of-acute-leukemias-guidance-for-industry-technical-specifications-document/fcae5d52-07e3-4b70-a7d3-d72bbe4ba316)
- [Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory](https://www.globalkeysolutions.net/guidances/guidance-document/submitting-clinical-trial-datasets-and-documentation-for-clinical-outcome-assessments-using-item-response-theory/9895a301-585a-4b74-83a1-3b526f3ec3d3)