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DDT COA #000007: The Cystic Fibrosis Respiratory Symptom Diary – Chronic Respiratory Infection Symptom Score (CFRSD-CRISS)

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Antimicrobial Products (OAP)
Division of Anti-Infective Products (DAIP)

DDT COA Number
DDT COA #000007

Instrument Name
The Cystic Fibrosis Respiratory Symptom Diary – Chronic Respiratory Infection Symptom Score (CFRSD-CRISS)

Disease/Condition
Cystic Fibrosis (CF)

Concept of Interest
CF symptom severity

Context of Use
Adolescents (≥12 years) and adults with a chronic respiratory infection in stable patients and patients with an acute exacerbation

COA Type
PRO

Qualification Stage
In legacy process*

Requestor(s)
Evidera
The Cystic Fibrosis Foundation

Contact(s)
Robin Pokrzywinski

Date Accepted into CDER’s COA Qualification Program
October 30, 2013

*Under review prior to the passage of the 21st Century Cures Act

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