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DDT COA #000040: Ulcerative Colitis Patient-Reported Outcomes Signs and Symptoms (UC-PRO/SS)

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Drug Evaluation (ODE) III
Division of Gastroenterology and Inborn Error Products (DGIEP)

DDT COA Number
DDT COA #000040

Instrument Name
Ulcerative Colitis Patient-Reported Outcomes Signs and Symptoms (UC-PRO/SS)

Disease/Condition
Ulcerative colitis (UC)

Concept of Interest
Signs and symptoms of UC

Context of Use
Adult patients (≥18 years of age) with moderate to severe UC

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
March 14, 2013

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