DDT COA #000005: Diary of Irritable Bowel Syndrome Symptoms- Constipation/ Diarrhea/ Mixed (DIBSS-C/D/M)
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Gastroenterology (DG)
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