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1. Question
At the site level, who is ultimately responsible for acceptable conduct of research?
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2. Question
It’s recommended to submit the protocol to the study team and Data Safety Monitor Committee (DSMC) for review and approval many times before the final submission.
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3. Question
All of the following are helpful tips for projecting and mitigating risk: (1) when developing the protocol, be precise and stay broad where you can; (2) include best practices in the Manual of Operations (MOP); (3) pivot a necessary if it does not impact the quality of the science.