DDT COA #000140: PROMIS Itch Questionnaire – Children Symptom (PIQ-C-Symptom)

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Dermatology and Dentistry (DDD)

DDT COA Number
DDT COA #000140

Instrument Name
PROMIS Itch Questionnaire – Children Symptom (PIQ-C Symptom)

Disease/Condition
Itch

Concept of Interest
Itch symptoms in children

Context of Use
PRO to be completed by children between ages 8-17 years
ObsRO to be completed by parents of children ages 5-17 years

COA Type
PRO and ObsRO

Qualification Stage
Letter of Intent-Not Accepted

Requestor(s)
Northwestern University

Contact(s)
Amy Paller
Jin-Shei Lai

Date Accepted into CDER’s COA Qualification Program
N/A

Submission and Regulatory Correspondence History

Qualification Submission	Date	FDA Submission Decision & Recommendations	Date
Letter of Intent	01/12/2021	FDA Response (Not Accepted)	3/26/21