DDT COA #000121: EORTC Quality of Life Core Questionnaire Physical Functioning (EORTC QLQ-C30)
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Oncologic Diseases (OOD)
DDT COA Number
DDT COA #000121
Instrument Name
EORTC Quality of Life Core Questionnaire Physical Functioning (EORTC QLQ-C30)
Disease/Condition
Cancer
Concept of Interest
Physical Functioning
Context of Use
Adult patients (>18 years) with cancer- all tumor types, locations, and stage of disease
COA Type
PRO
Qualification Stage
Letter of Intent- Not Accepted
Requestor(s)
EORTC QLQ-C30 Working Group
Contact(s)
Dennis Revicki
Date Accepted into CDER’s COA Qualification Program
N/A
Submission and Regulatory Correspondence History
| Qualification Submission | Date | FDA Submission Decision & Recommendations | Date |
|---|---|---|---|
| Letter of Intent | 1/15/20 | FDA Response (Not Accepted) | 3/25/20 |