protocol deviation

protocol deviation

A variation from the processes or procedures defined in a (clinical study) protocol that usually do not preclude overall evaluability of subject/patient data for efficacy or safety, and are often acknowledged and accepted in advance by the sponsor.

Good clinical practice recommends that deviations be summarised by site and by category as part of the report of study results so that the possible importance of the deviations to the findings of the study can be assessed.
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References in periodicals archive ?
Of the 157 patients who were randomized, 18 patients (11.5%) had discontinued treatment by week 24, with 3 patients stopping for adverse events, 3 for protocol deviation or noncompliance, and 10 withdrawals.
"We are developing a method that we hope to roll out in the latter part of this year that will enable us to identify participants who are at high risk for drop-off or protocol deviation. It's like identifying a readiness or willingness to change.
One significant adverse event was a protocol deviation in which 1 patient received an incorrect dose of IV sodium fluorescein (500 mg) instead of the recommended 25-mg dose.
Eighty-five patients (including the six patients excluded from the ITT population) presented at least one major protocol deviation and were thus excluded from the PP population.
In total 164 patients were enrolled and randomly allocated to receive berberine or placebo, of which 12 subjects in the berberine arm and 20 from the placebo arm were subsequently excluded because of voluntary withdrawal or protocol deviation. Thus 70 patients in the berberine and 62 in the placebo group completed the study with available data for analysis.
If the use of electrocautery was required in patients allocated to the nonintervention group, this protocol deviation was to be annotated; however, no such situation occurred during the study period.
In fact, protocol deviation was so significant that it invalidated the primary outcome of the study and the results looked too good to be true--they were.
This protocol deviation did not affect the laboratories' abilities to detect weight increases in response to TP but was a source of a significant laboratory-to-laboratory variability when all laboratories were pooled ([R.sup.2] = 36%).
Reasons for attrition included withdrawal of consent, protocol deviation, unavailability, and adverse experiences.
The entire team met for an hour each week to review each instance where a clinician deviated from protocol to (1) change the protocol (2) agree that the protocol was correct, or (3) decide that the protocol deviation was justified but represented a rare event.
Other reasons for discontinuation were pregnancy, protocol deviation, and physician or patient decision.

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