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Submission of study protocols to RECs constitutes one of the earliest stages at which planned trials are documented in detail.
Submission of study protocols to research ethics committees (RECs) constitutes one of the earliest stages at which planned trials are documented in detail.
Centralized Institutional Review Boards (New England Institutional Review Board in 2007 and Copernicus Group Independent Review Board from 2008 to 2011) approved the studies and iterative submission of study documents (study protocol, interview guides, patient information and informed consent form, and health information and demographic form).
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The submission of studies with statistically negative results needs to be encouraged, especially in basic science.
CERA therefore encourages submission of studies that advance the broader field of priority-setting, in terms of methodological or conceptual contributions, as well as empirical case studies.
Finally, CERA recognizes that cost and cost-effectiveness analysis alone may not provide sufficient information to decision makers to guide their choices on the allocation of resources, and therefore encourages submission of studies that advance the broader field of priority-setting.
A recent German observational study on VKA-OAC (n = 1,176), published after the submission of our study, suggested that rapid reversal of INR is associated with less ICH expansion and lower in-hospital mortality, but was not powered to compare reversal therapies due to a uniform national practice of using PCC.
We can suppose that there is a reward, R(Y), and a cost C(Y) of submission of a study with outcome Y where Y = 0,1 according to whether the study is negative or positive.
Yet this was known at the time of submission of our study.
At the time of submission of this study protocol participants were still being recruited.
HS-G participated essentially in establishment of laboratory analyses, their evaluation and statistics, but unfortunately died before submission of this study.
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