DDT COA #000007: The Cystic Fibrosis Respiratory Symptom Diary – Chronic Respiratory Infection Symptom Score (CFRSD-CRISS)
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Infectious Diseases (OID)
Division of Anti-Infectives (DAI)
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