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

DDT COA Number
DDT COA #000034

Instrument Name
Crohn’s Disease Patient-Reported Outcomes Signs and Symptoms (CD-PRO/SS)

Disease/Condition
Crohn’s disease (CD)

Concept of Interest
Signs and symptoms of CD

Context of Use
Adult patients (>18 years) with moderate to severe clinically active CD treated in the outpatient setting

COA Type
PRO

Qualification Stage
Letter of Intent-Accepted

Requestor(s)
IBD PRO Consortium

Contact(s)
Gale Harding

Date Accepted into CDER’s COA Qualification Program
April 1, 2013

Submission and Regulatory Correspondence History