DDT COA #000102: Physical Activity Accelerometry Assessment for Analgesic Clinical Trials (PAACT)

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Neuroscience (ON)
Division of Anesthesia, Addiction Medicine, and Pain Medicine (DAAP)

DDT COA Number
DDT COA #000102

Instrument Name
Physical Activity Accelerometry Assessment for Analgesic Clinical Trials (PAACT)

Disease/Condition
Musculoskeletal pain

Concept of Interest
Physical activity

Context of Use
Non-cognitively impaired adults with a diagnosis of osteoarthritis of the knee

COA Type
DHT- Passive Monitoring COA

Qualification Stage
Letter of Intent - Accepted

Requestor(s)
Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION)

Contact(s)
Jennifer Gewandter

Date Accepted into CDER’s COA Qualification Program
May 31, 2018

Submission and Regulatory Correspondence History

Qualification Submission	Date	FDA Submission Decision & Recommendations	Date
Letter of Intent	12/14/17	FDA Response (Accepted)	5/10/18