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Performed Protocol Deviation Date Range
The date and time span specifying when the protocol deviation began and ended. (NCI Thesaurus)
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A coded value specifying a classification of protocol deviation.
A variation from process or procedures defined in a study protocol.
A completed activity of transporting a product between a point of origin and a point of destination. EXAMPLE(S):Delivery of drugs from the…
Based on FDA CDRH Conclusion Codes.
A coded value specifying the relevant fact within the context of the evaluation final results for a reported suspect medical device. …
A coded value specifying the defect or malfunction that occurred during use of the suspect device whether or not the problem is…
