Sentence examples for serious protocol deviation from inspiring English sources

In case of a serious protocol deviation, the research team will assess the possibility of withdrawing the patient from the study.

In addition a per-protocol analysis will be performed, analysing only those patients with no serious protocol deviations.

This means that most patients, also those who did not have a sufficient intensity or showed serious protocol deviations, were included in the analyses.

No serious adverse events, one minor protocol deviation and one pharmacy protocol violation were reported.

Withdrawal criteria included serious adverse events, pregnancy, the necessity of stopping study treatment, and major protocol deviation as judged by a study committee.

Significant protocol deviation or violation.

One Japanese subject was withdrawn due to a protocol deviation.

Protocol deviation or protocol non-adherence by patients, GPs or researchers is common.

The per protocol (PP) population excluded those in the ITT population with a major protocol deviation.

The principal investigator (PI) considers that there has been a serious protocol violation.

Treatment/sham insonation was initiated according to trial requirements of 30 min after t-PA bolus and no serious adverse events or major protocol deviations occurred.