United States Food and Drug Administration Qualified Clinical Outcome Assessment (FDA-COA)
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A United States Food and Drug Administration Qualified Clinical Outcome Assessment (FDA-COA) is a Clinical Outcome Assessment that has passed the FDA's COA qualification project.
- Example(s):
- Counter-Example(s):
- See: IRB Approval, Adverse Event Measure, Clinical Procedure, Therapeutic Treatment Event, Observation About a Human, Clinical Trial, Case Report Form (CRF), Clinical Research Instrument, Clinical Trial Validate Instrument.
References
2021a
- (FDA, 2021) ⇒ https://www.fda.gov/about-fda/clinical-outcome-assessment-coa-frequently-asked-questions#COADefinition
- QUOTE: A clinical outcome assessment is a measure that describes or reflects how a patient feels, functions, or survives. Types of COAs include:
2021b
- (FDA, 2021) ⇒ https://www.fda.gov/drugs/clinical-outcome-assessment-coa-qualification-program/qualified-clinical-outcome-assessments-coa Retrieved:2021-12-30.
- QUOTE: The table below lists qualified Clinical Outcome Assessments (COA). The tables include legacy projects (those submitted prior to passage of the 21st Century Cures Act), as well as those submitted as part of the newer section 507 process (referring to section 507 of the Federal Food, Drug and Cosmetic Act (FD&C Act)), which was created by Section 3011 of the 21st Century Cures Act). The tables are updated on a biannual basis and provide information on the COA qualification project, qualification statement, and supporting information. Additionally, the table includes documents from requestors that were received after the passage of the 21st Century Cures Act.