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Managing a Multicenter RCT: Lessons Learned – Post Quiz

  1. At the site level, who is ultimately responsible for acceptable conduct of research?

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  2. 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. 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.

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