Clinical Outcome Assessments (COA) Qualification Submissions
Office of Neuroscience (ON)
Division of Neurology I (DN I)

DDT COA Number
DDT COA #000032

Instrument Name
Abilities Captured through Interactive Video Evaluation (ACTIVE)-seated

Disease/Condition
Dystrophinopathy

Concept of Interest
Functional reaching volume (FRV) intended to encompass upper extremity and trunk movement

Context of Use
Children (>4-12 years) and adolescents (12-17 years) and adults with Duchenne muscular dystrophy (DMD) or Becker muscular dystrophy (BMD)

COA Type
PerfO

Qualification Stage
Letter of Intent-Accepted

Requestor(s)
The Research Institute at Nationwide Children’s Hospital

Contact(s)
Linda Lowes

Date Accepted into CDER’s COA Qualification Program
May 30, 2013

Submission and Regulatory Correspondence History