protocol violation


Also found in: Acronyms.

protocol violation

A term of art used in clinical trials for a significant departure from processes or procedures delineated in the protocol. Violations often result in data deemed inevaluable for protocol analysis, and may require that the patient(s)/subject(s) who violate the protocol be discontinued from the study.
Segen's Medical Dictionary. © 2012 Farlex, Inc. All rights reserved.
References in periodicals archive ?
As we noted earlier, the number of patients with protocol violations was too high due to the lack of experience in early phases of the study.
2, which does not include the unknown readings, shows the number of glucose readings obtained for each patient and the proportion of protocol violations per patient.
All of the patients had minor violations of American Heart Association guidelines for thrombolytic therapy for acute stroke; 52% "had major protocol violations," including giving rTPA after the recommended 3-hour therapeutic window or giving the drug before confirming an ischemic stroke diagnosis.
While recalling the incidents leading to the blockade, HE Sheikh Abdulrahman said it had its beginning before the US-Islamic Forum meeting in the US where there were protocol violations and editors and journalists were not invited for the mandatory press conference at the end of the conference.
Taking to Twitter, Singh said, "Shri Rahul Gandhi undertook 121 tours in the last 2 years, out of which there were 100 security protocol violations of not using BR Car."
In this issue of SAJCC, we publish a study by Maharaj et al., [3] showing that protocol violations in blood glucose control in a cardiothoracic ICU are very common and results in wide swings in glucose levels.
The study involved 137 subjects who received at least one dose of the study drug (the ITT population); of this number, 124 subjects completed the trial without any significant protocol violations that could impact the primary efficacy endpoint result.
Ultimately, progress and the competition to stay on top of the competition are at fault for e-mail protocol violations. The adoption of technology has far outpaced the ability of organizations to keep up with the implications of using it.
A multi-site, multi-national Phase III trial did not achieve its desired endpoint, an outcome the company believes is attributable to protocol violations at a number of sites in Eastern Europe and elsewhere.
A total of 194 patients were excluded because of protocol violations, study withdrawal, or failing to meet inclusion criteria, leaving 7,220 patients in the aspirin group and 7,244 in the no-aspirin group for the modified intention-to-treat population.
Among 574 telepsychiatry sessions, there were 29 protocol violations, which usually involved changing the algorithm order or combining medications.
The Sofia Court of Appealas distraint upon the City hallas account is a result of numerous contract and protocol violations concerning a company providing services for the new Rila mountain park.