DDT COA #000036: Impact of Weight on Quality of Life- Lite (IWQOL-Lite) Clinical Trials Version
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN)
Division of Diabetes, Lipid Disorders, and Obesity (DDLO)
DDT COA Number
DDT COA #000036
Instrument Name
Impact of Weight on Quality of Life- Lite (IWQOL-Lite) Clinical Trials Version
Disease/Condition
Obesity
Concept of Interest
weight-related quality of life concepts
Context of Use
- Obese adults with no weight-related comorbidities and
- Overweight and obese adults with >1 weight-related comorbidity
COA Type
PRO
Qualification Stage
Letter of Intent-Accepted
Requestor(s)
Quality of Life Consulting & Duke University Medical Center
Contact(s)
Ronette Kolotkin
Date Accepted into CDER’s COA Qualification Program
April 19, 2013
Submission and Regulatory Correspondence History
|
Qualification Submission |
Date |
FDA Submission Decision & Recommendations |
Date |
|---|---|---|---|
|
9/5/19 |