Performed Protocol Deviation Subcategory Code

A coded value specifying a subdivision within a larger category of a protocol deviation. EXAMPLE(S): prohibited medication, missed dose of study medication, missed recording data in diary, late visit (for minor deviations). (NCI Thesaurus/BRIDG)

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Performed Protocol Deviation Date Range

The date and time span specifying when the protocol deviation began and ended.

Performed Protocol Deviation Category Code

A coded value specifying a classification of protocol deviation.

Performed Protocol Deviation

A variation from process or procedures defined in a study protocol.

Performed Product Transport

A completed activity of transporting a product between a point of origin and a point of destination. EXAMPLE(S):Delivery of drugs from the…

Performed Product Problem Discovery

Based on FDA CDRH Conclusion Codes.

Performed Product Investigation Result Evaluation Conclusion Code

A coded value specifying the relevant fact within the context of the evaluation final results for a reported suspect medical device. …