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DDT COA #000005: Diary of Irritable Bowel Syndrome Symptoms- Constipation/ Diarrhea/ Mixed (DIBSS-C/D/M)

DDT COA #000005: Diary of Irritable Bowel Syndrome Symptoms- Constipation/ Diarrhea/ Mixed (DIBSS-C/D/M)

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 #000005

Instrument Name
Diary of Irritable Bowel Syndrome Symptoms- Constipation/ Diarrhea/ Mixed (DIBSS-C/D/M)

Disease/Condition
Irritable Bowel Syndrome (IBS)

Concept of Interest
IBS signs and symptoms

Context of Use
Adult patients with IBS-C, IBS-D, or IBS-M

COA Type
PRO

Qualification Stage
In transition to 507 process 

Requestor(s)
Critical Path Institute: Patient-Reported Outcome (PRO) Consortium
Irritable Bowel Syndrome (IBS) Working Group

Contact(s)
Stephen Coons

Date Accepted into CDER’s COA Qualification Program
April 29, 2010

Back to Clinical Outcome Assessments (COA) Qualification Submission