Sentence examples for serious protocol violation from inspiring English sources
There was one serious protocol violation: during May June 200707 one porridge ran out but staff continued to recruit to the other treatment; the children who were thus not appropriately randomised were followed for ethical reasons but are not included in the present analyses.
The principal investigator (PI) considers that there has been a serious protocol violation.
A further three patients were removed from the analysis due to missing documentation or serious protocol violation (radiotherapy to the only site of disease), leaving 108 cases for the baseline and safety analyses.
Adaptive designs deal with issues that may arise during a trial, such as poor recruitment, serious protocol violations, and unanticipated rates of adverse events [ 8].
However, patients with serious study protocol violations (i.e., informed consent not obtained or serious violations of the study procedures) will be excluded.
The investigator also has the right to withdraw patients from the study in the event of inter-current illness, adverse events or serious adverse events, protocol violations, administrative reasons or other reasons.
The Chief Investigator will also have the right to withdraw participants from the study in the event of adverse events, serious adverse events, suspected unexpected serious adverse reactions or protocol violations.
Discontinuation criteria included voluntary retraction of consent, serious clinical abnormality, unsuitability for evaluation, inability to present for evaluation, protocol violation, or investigator's decision due to medical or nonmedical reasons.
Criteria for withdrawals and expected analysis of withdrawals and dropouts: Serious adverse event Unsatisfactory therapeutic effect Patient clinical conditions prevent compliance with the protocol Protocol violation Informed consent withdrawal Patients can choose to interrupt the medication any time during the course of the study.
Significant protocol violation or non-compliance.
