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  5. DDT COA #000121: EORTC Quality of Life Core Questionnaire Physical Functioning (EORTC QLQ-C30)
  1. Drug Development Tool (DDT) Qualification Programs

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