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DDT COA #000034: Crohn’s Disease Patient-Reported Outcomes Signs and Symptoms (CD-PRO/SS)

DDT COA #000034: Crohn’s Disease Patient-Reported Outcomes Signs and Symptoms (CD-PRO/SS)

Office of Drug Evaluation (ODE) III
Division of Gastroenterology and Inborn Error Products (DGIEP)

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
In transition to 507 process 

Requestor(s)
IBD PRO Consortium

Contact(s)
Gale Harding

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

Back to Clinical Outcome Assessments (COA) Qualification Submission