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On the basis of a pretest of the selected instrument, however, we made one modification to the study theory.
Although there does seem to be a likely relation between a long travel and the development of an episode of VTED, such an association must be of such a magnitude that a small bias or modification to the study could increase or decrease the strength of the association recorded.
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Results validated that the intervention, methods and outcomes for the planned study were important, but modifications to the study protocol resulted.
LBD, WN, and JHT held weekly meetings to discuss the interviews/coding and make appropriate modifications to the study guide.
During a 16-week period in 2003 we conducted a pilot study, which tested the intervention and data collection procedures, and led to modifications to the study design.
The core NCS hypotheses are dynamic, and as the study is implemented, new questions will emerge and result in modifications to the study protocol.
The DSMC makes recommendations to the Principal Investigator and the Office of Clinical and Regulatory Affairs at the National Center for Complementary and Alternative Medicine regarding continuation, termination, or other modifications to the study.
A Data Safety Monitoring Board analysed data during the course of the study to advise the clinical study team of any potential modifications to the study conduct necessary to minimize potential risks to subjects.
Soon after recruitment of individuals was initiated and study research staff met with service teams on site, there were a few practical and feasibility issues identified that led to the following modifications to the study protocol.
Following this phase of the study, the parents/guardians of participants were invited to attend a focus group to provide feedback on their experiences and to suggest modifications to the study.
A steering committee oversees the conduct of the trial and an independent data monitoring committee receives unblinded data and has the power to recommend to the steering committee modifications to the study conduct, including early discontinuation of the study, based on a risk/benefit assessment of the study data.
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