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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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.
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.
Difference between a A protocol deviation is any change, "protocol divergence, or departure from the study deviation," an design or procedures defined in the "important protocol protocol.
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.
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.
Perhaps we want to know if a protocol deviation or query is not resolved in a timely manner.
Reducing trial costs and protocol deviation, Firecrest is proven to enhance compliance, consistency, and the quality of execution for all study-related procedures and activities.
Reducing trial costs and protocol deviation, Firecrest Clinical is proven to enhance compliance, consistency, and the quality of execution for all study-related procedures and activities.
Pink Sheets:CYDY), as the study sponsor, has been advised of a protocol deviation that occurred in a murine study of dosing and immunogenicity for DNA-based bird flu vaccines.

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