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Further, there were no significant differences between enrollment centers in regards to protocol deviations, time to delivery of trial drug, or duration of participation in the trial.
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With regard to protocol amendment, we did not consider statistical correction.
Because of this lack of information, it is unclear whether the results of the study would be applicable to other studies in regard to protocol or scaffold manufacturing.
The practical aspects of the study were discussed including recruitment and screening strategies, management of any adverse events, technical considerations relating to data collection and recording, as well as responsibilities with regard to protocol adherence, quality assurance and logistical support.
(Perhaps that is why he forged such a close relationship with our own monarch, whom he called "Elizabeth" without any regard to protocol).
Vector construct was identical for both preparations that only differed in regard to protocols employed for their purification (Additional file 1: Figure S1).
Adherence to protocol regarding immunogenicity was met if volunteer had blood samples before vaccination and 30 (21–100 d) days after.
The studies that form the basis of these reviews differ greatly in regards to design, protocol, application technique and length of follow-up.
There is no consensus with regards to the protocol (dynamic versus quasistatic) and magnitude of the load applied; however, both preload and torque/displacement patterns and magnitudes should be specified, even when their magnitude is zero.
The role of clinical research associates (CRAs) or study monitors is principally to train the study sites with regards to the study protocol, rather than to ensure the oversight of laboratory methods or to consider the implementation and management of quality systems in the laboratory.
More than 60% of the patients had an immediate inclusion in the study with regard to the protocol (24 hours after admission to the intensive care unit).
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