Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Gastroenterology (DG)

DDT COA Number
DDT COA #000092

Instrument Name
PROMIS® Pediatric Crohn’s Disease Short Form – Fatigue 10

Disease/Condition
Crohn’s disease (CD)

Concept of Interest
Fatigue (frequency, duration and intensity)

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

COA Type
PRO

Qualification Stage
Letter of Intent – Accepted

Requestor(s)
Anthony Otley

Contact(s)
Carole Tucker
Christopher Forrest

Date Accepted into CDER’s COA Qualification Program
July 11, 2017

Submission and Regulatory Correspondence History