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  4. Drug Development Tool (DDT) Qualification Programs
  5. Clinical Outcome Assessment (COA) Qualification Program
  6. DDT COA #000148: Diary for Irritable Bowel Syndrome Symptoms- Diarrhea (DIBSS-D)
  1. Clinical Outcome Assessment (COA) Qualification Program

DDT COA #000148: Diary for Irritable Bowel Syndrome Symptoms- Diarrhea (DIBSS-D)

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Gastroenterology (DG)

DDT COA Number
DDT COA #000148

Instrument Name
Diary for Irritable Bowel Syndrome Symptoms- Diarrhea (DIBSS-D)

Disease/Condition
Irritable Bowel Syndrome (IBS)

Concept of Interest
Symptom severity

Context of Use
Adults who meet Rome diagnostic criteria (Rome III or IV) and have active symptoms

COA Type
PRO

Qualification Stage
Letter of Intent- Accepted

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

Submission and Regulatory Correspondence History

Qualification Submission

Date

FDA Submission Decision & Recommendations

Date

Transition Summary

4/20/21

FDA Response

4/26/21

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