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DDT COA #000080: PROMIS® Fatigue Item Bank

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Drug Evaluation (ODE) II
Division of Pulmonary, Allergy, and Rheumatology Products (DPARP)

DDT COA Number
DDT COA #000080

Instrument Name
PROMIS® Fatigue Item Bank

Disease/Condition
Chronic Fatigue Syndrome (CFS)
Myalgic Encephalomyelitis (ME)
Systemic Exertion Intolerance Disease (SEID)

Concept of Interest
Fatigue

Context of Use
Patients with CFS, ME, or SEID

COA Type
PRO

Qualification Stage
In transition to 507 process 

Requestor(s)
San Keller

Contact(s)
San Keller

Date Accepted into CDER’s COA Qualification Program
October 8, 2015

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