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.
References in periodicals archive ?
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.
Protocol violations most commonly result from errors in the screening process, including incomplete and inaccurate medical records.
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.
When considering the problem of study protocol violations related to the use of prohibited medications, which would confound the response analysis, the data reveal that the highest dose of Synavive demonstrated statistically significant differences, which are likely to be clinically important, compared to placebo effects, and numeric superiority compared to the low dose prednisolone arm.
8, Sonics' SoC development tool, includes the JEDA OCPchecker, a SystemC based OCP compliance checker to pinpoints protocol violations under virtual platform simulation environments.
4% in the Viread/Emtriva/SUSTIVA group) and other reasons including lost to follow-up, patient withdrawal, non-compliance and protocol violation (14% vs.
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.
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.
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.