protocol deviation
[ˈprɒtəkɒl ˌdiːviˈeɪʃən]
nounpl: protocol deviations
desvio de protocolo
1. Any departure from the established procedures, guidelines, or predetermined plan in a clinical trial, research study, or formal procedure
The investigator documented the protocol deviation when the patient missed the scheduled follow-up appointment.
O investigador documentou o desvio de protocolo quando o paciente não compareceu à consulta agendada.
2. In clinical research, any unplanned change to the study design or procedure that occurs during the execution of a research study
Protocol deviations must be reported to the ethics committee within 48 hours.
Os desvios de protocolo devem ser reportados ao comitê de ética dentro de 48 horas.
3. Non-compliance with the predetermined rules or procedures established in a formal protocol
The hospital implemented stricter controls to minimize protocol deviations in surgical procedures.
O hospital implementou controles mais rigorosos para minimizar desvios de protocolo nos procedimentos cirúrgicos.
Protocol deviations are a critical concern in both Brazilian and North American clinical research and healthcare settings. In the USA, the FDA requires detailed documentation of all deviations. In Brazil, ANVISA (Agência Nacional de Vigilância Sanitária) maintains similar strict requirements. These deviations must be recorded and can impact the validity of clinical trial results and regulatory approval of new treatments.
Related Idioms & Phrases
to report a protocol deviation
to document a protocol deviation
to justify a protocol deviation
minor/major protocol deviation
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