As global, multi-center medical device studies become increasingly common, trial monitoring is growing more complex. Regulators require that sponsors perform site monitoring to ensure that investigators are compliant with federal regulations, sponsor agreements, investigational plans, and the requirements set forth by the study’s institutional review board.
Additionally, sponsors are responsible for selecting qualified monitors to oversee the safety of trial participants. They may appoint other individuals and groups, such as a data monitoring committees (DMCs) or clinical endpoint committees (CECs), to ensure compliance and proper clinical trial monitoring.
In this webcast, we’ll describe what these committees do and discuss how sponsors can best determine what type of study oversight is appropriate. Working with a CRO partner who understands when and how to leverage these oversight groups can help sponsors manage and operate these committees in an efficient manner that is customized to the nuances of their trials.
Key Learning Objectives:
- The key differences and responsibilities of DMCs and CECs
- How to determine which committee to use on your study, if not both
- How a CRO can help navigate the complexity of appointing a committee