Evaluation Definitions
ACCEPTABLE – PER PROTOCOL:
The radiation therapy treatment was delivered to the patient according to the protocol specifications and meets the acceptable – per protocol criteria as defined by the protocol.
ACCEPTABLE VARIATION:
The radiation therapy treatment was delivered to the patient not according to all of the protocol specifications, but no major clinical impact is expected due to the deviation(s) that would affect the trial outcome. The observed protocol deviations did not exceed the protocol criteria defined for an acceptable variation.
UNACCEPTABLE VARIATION:
At patient level: The patient has been planned/treated not according to the protocol and this deviation could have a clinical impact on him/her.
The radiation therapy treatment delivered to the patient did not meet all of the protocol specifications, and the variation(s) were great enough possibly to have clinical impact that would affect the trial outcome. The variation(s) exceed the protocol’s defined unacceptable variation criteria. The consequence of the deviation(s) is deemed significant enough by the trial Principal Investigator to increase the trial’s uncertainty and thus might increase the probability that the true trial outcome is obscured if the patient’s data were included in the trial’s final analysis.
UNACCEPTABLE VARIATION WITH TREATMENT MODIFICATION:
The radiation therapy treatment delivered to the patient did not meet all of the protocol specifications, and the variation(s) exceed the protocol’s defined unacceptable variation criteria. The unacceptable variation radiation therapy treatment is delivered due to clinical necessity as perceived by the treating physician. The consequence of the deviation(s) is deemed significant enough by the trial Principal Investigator to increase the trial’s uncertainty and thus might increase the probability that the true trial outcome is obscured if the patient’s data were included in the trial’s final analyses . The institution is not penalized for this treatment variation.