DDT COA #000092: PROMIS® Pediatric Crohn’s Disease Short Form - Fatigue 10
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
| Qualification Submission | Date | FDA Submission Decision & Recommendations | Date |
|---|---|---|---|
| Letter of Intent | 1/31/17 | FDA Response (Accepted) | 7/11/2017 |