DDT COA #000095: PROMIS® Pediatric Chronic Kidney Disease Short Form- Fatigue

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN)
Division of Cardiovascular and Nephrology (DCN)

DDT COA Number
DDT COA #000095

Instrument Name
PROMIS® Pediatric Chronic Kidney Disease Short Form- Fatigue

Disease/Condition
Chronic Kidney Disease (CKD)

Concept of Interest
Fatigue

Context of Use
Children (8-17 years) with CKD

COA Type
PRO

Qualification Stage
Letter of Intent- Accepted

Requestor(s)
Pediatric Patient Reported Outcomes in Chronic Diseases (PEPR) Consortium

Contact(s)
Julia Schuchard

Date Accepted into CDER’s COA Qualification Program
February 5, 2020

Submission and Regulatory Correspondence History

Qualification Submission	Date	FDA Submission Decision & Recommendations	Date
Letter of Intent	9/26/19	FDA Response (Accepted)	2/5/20