C164349Level 6

Study Agent Deviation

**Semantic type:** Conceptual Entity

**Definition:** An indication that a protocol deviation involved a study agent.

**Synonyms:** - Study agent/medication

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C209823Non-Study Agent/Medication Modality: Other

C209840Incorrect Imaging Agent/Dose Administered

C209855Study-Supplied Agent/Medication Substituted With Non-Study-Supplied Agent/Medication, Including Commercial Agent/Medication

C209856Study Agent/Medication Administered to Wrong Patient/Study Participant

C209857Study Agent/Medication Prepared Incorrectly

C209858Study Agent/Medication Prescribed by Unauthorized Prescriber

C209859Treatment/Dose Modifications/Intervention Not Per Protocol

C209861Study Agent/Medication Stored Incorrectly

C209862Study Agent/Medication: Other

C209863Study Agent/Medication Incorrect, Not Administered Correctly, or Not Adequately Documented

C209864Timing and Sequencing of Study Agent/Medication Not Per Protocol

C209866Non-Study Agent/Medication Treatment Modality

C225562Incorrect Dosage Regimen for the Background Medication/Rescue Medication

C225563Incorrect Dosage Regimen For the Study Intervention

C225564Incorrect Treatment Kit Used

C225565Incorrect Route of Administration for the Background Medication/Rescue Medication

C225566Incorrect Route of Administration for the Study Intervention

C225567Incorrect Study Intervention

C225574Study Intervention Administered Outside the Protocol-Defined Window

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