DDT COA #000116: PROMIS Itch Questionnaire – Children Impact (PIQ-C-Impact)
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Dermatology and Dentistry (DDD)
DDT COA Number
DDT COA #000116
Instrument Name
PROMIS Itch Questionnaire – Children Impact (PIQ-C Impact)
Disease/Condition
Itch
Concept of Interest
Itch impacts on children’s daily living
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 |