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DDT COA #000032: Abilities Captured through Interactive Video Evaluation (ACTIVE)-seated

DDT COA #000032: Abilities Captured through Interactive Video Evaluation (ACTIVE)-seated

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Drug Evaluation (ODE) I
Division of Neurology Products (DNP)

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
In transition to 507 process 

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

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