DDT COA #000093: PROMIS® Pediatric Crohn’s Disease Short Form- Pain Interference
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Gastroenterology (DG)
DDT COA Number
DDT COA #000093
Instrument Name
PROMIS® Pediatric Crohn’s Disease Short Form- Pain Interference
Disease/Condition
Crohn’s Disease (CD)
Concept of Interest
Pain Interference
Context of Use
Children (8-17 years) with CD
COA Type
PRO
Qualification Stage
Letter of Intent- Not Accepted
Requestor(s)
Pediatric Patient Reported Outcomes in Chronic Diseases (PEPR) Consortium
Contact(s)
Carole Tucker
Christopher Forrest
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 | 8/5/19 | FDA Response (Not Accepted) | 9/26/19 |