clinical outcome assessment qualification
- Guideline or reference source
- FDACOA Clinical outcome assessment glossary
- Definition
- COA qualification represents a conclusion that within the stated context of use (COU), the results of the COA measurement can be relied upon to have a specific interpretation and application as long as there are no serious study flaws and there are no new and conflicting scientific facts not known at the time the qualification was determined. COAs traditionally used may still be acceptable even though they have not been qualified, however, the use of such COAs will continue to be reviewed on a case-by-case basis. For qualified COAs, drug developers will be able to use the COA in the qualified context in IND and NDA/BLA submissions without requesting that the relevant CDER review group reconsider and reconfirm the suitability of the COA.
- Related Term
- clinical outcome assessment
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