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 ?
Protocol violations most commonly result from errors in the screening process, including incomplete and inaccurate medical records.
It automatically captures real-time compliance protocol violations, detects post-process protocol violations on captured traces, takes performance measurements, and creates physical address triggers.
In such instances, the primary purpose of the interaction is for the researchers to articulate the means by which risk to the organisation and patients, and protocol violations will be minimised.
After exclusion of 49 patients because of severe protocol violations, the 28-day mortality rate was 42.
All the seizures occurred at one institution where blood pressure control protocol violations were subsequently documented, Dr.
Switches provide some natural fault isolation of misbehaving nodes because they do not route packets through any node other than the one being addressed, but they can also log the detection of improper packets or bus protocol violations for later examination by the EMU.
Over 50 timing and protocol violations are continuously monitored across two (2) DIMMs per channel, four (4) ranks per DIMM and eight (8) banks per rank for DDR3 or four (4) bank groups per rank and four (4) banks per bank group for DDR4.
Sixteen percent of subjects withdrew because of adverse events, roughly the same number as for protocol violations.
Collaborative effort creates Protocol Violations module for eCaseLink[TM] Electronic Data Capture --
The MCA4000 memory compliance analyzer features a dual architecture that enables the detection of protocol violations coupled with the ability to acquire and analyze violations and determine bus performance.
However, larger companies with bigger overall staffs manage greater risk as each new employee represents the potential for protocol violations, for SOP non-adherence, or for off-label conversations with physicians.