1. Medical treatment administered outside the established clinical guidelines, approved protocols, or standard procedures for a particular condition
The patient requested off-protocol treatment after conventional therapies failed.
O paciente solicitou um tratamento fora do protocolo após o fracasso das terapias convencionais.
2. Therapeutic intervention that deviates from evidence-based medical standards or clinical trial parameters
Off-protocol treatment requires special informed consent from the patient.
O tratamento fora do protocolo requer consentimento informado especial do paciente.