Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Hepatology and Nutrition (DHN)

DDT COA Number
DDT COA #000075

Instrument Name
Polycystic Liver Disease Questionnaire (PLD-Q)

Disease/Condition
Polycystic Liver Disease (PLD)

Concept of Interest
PLD symptoms

Context of Use
Adult patients with Gigot stage II or III PLD

COA Type
PRO

Qualification Stage
Letter of Intent-Accepted

Requestor(s)
Marie Hogan
Jeff Sloan

Contact(s)
Marie Hogan

Date Accepted into CDER’s COA Qualification Program
February 8, 2016

Submission and Regulatory Correspondence History