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In this section: Clinical Outcome Assessment (COA) Qualification Program

DDT COA #000079: PROMIS® Physical Function in Oncology

Office of Oncologic Diseases (OOD)

DDT COA Number
DDT COA #000079

Instrument Name
PROMIS® Physical Function in Oncology

Disease/Condition
Cancer

Concept of Interest
Physical functioning

Context of Use
Adult patients (> 18 years) with solid tumors or hematologic malignancies with a performance status range 0-3 and receiving active anti-cancer therapy

COA Type
PRO

Qualification Stage
Qualification Plan- Accepted

Requestor(s)
David Cella

Contact(s)
David Cella

Date Accepted into CDER’s COA Qualification Program
November 3, 2015

Submission and Regulatory Correspondence History

Qualification Submission	Date	FDA Submission Decision & Recommendations	Date
Qualification Plan	10/11/19	FDA Response (Accepted)	2/10/20

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