Managing a Multicenter RCT: Lessons Learned – Post Quiz

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

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.

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.