DDT COA #000005: Diary for Irritable Bowel Syndrome Symptoms – Constipation (DIBSS-C)

Qualified Clinical Outcome Assessments (COA)
Office of Immunology and Inflammation (OII)
Division of Gastroenterology

DDT COA Number
DDT COA #000005

Instrument Name
Diary for Irritable Bowel Syndrome Symptoms – Constipation (DIBSS-C)

Disease/Condition
Irritable Bowel Syndrome (IBS)

Concept of Interest
Aspects of symptom experience associated with irritable bowel syndrome with constipation

Context of Use
Patients 18 years and older with a diagnosis of IBS-C as defined by the Rome Criteria and the final FDA IBS Guidance

COA Type
PRO

Requestor(s)
Critical Path Institute: Patient-Reported Outcome (PRO) Consortium

Contact(s)
Sonya Eremenco

Date Accepted into CDER’s COA Qualification Program
May 14, 2015

Qualification Date
December 18, 2020
Qualification Statement

Submission and Regulatory Correspondence History

Qualification Submission	Date	FDA Submission Decision & Recommendations	Date
Full Qualification Package	12/20/2018	FDA Response (Qualified)	12/18/20