As you did all the thinking already, it should be feasible to copy/paste from the trial protocol. The basics of calculating sample size are covered in substantial detail in the PREPARE Trial guide.1 ...
The guide contains directions, examples and sample text for filling out HRP-503, the protocol template. It correlates with the IRB template to be released in January 2016. It will be updated to ...
Real world data (RWD), which is data from actual patient treatments, provides valuable information on safety and effectiveness of innovative ...
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