Titlebook: Data Monitoring Committees (DMCs); Past, Present, and F Nand Kishore Rawat,David Kerr Book 2023 The Editor(s) (if applicable) and The Autho

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What About In-Between DMC Meetings?,This chapter mentions materials that might be sent to the DMC outside of the normal DMC meetings. These primarily are deaths, SUSARs, and/or SAEs. The pros and cons of these are weighed and what the process could be to help the DMC keep informed between DMC meetings without burdening them.

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Physiogenic Hearing Impairment in Adults, and setting the stage for the value of a Data Monitoring Committee (DMC) in such a study. The DMC provides value by reviewing safety and efficacy data, and then making recommendations. These recommendations are made to help ensure study integrity and to protect the patients – ultimately up to reco

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Ralph Tench,Dejan Ver?i?,Piet Verhoevenactivities to help the DMC. Regulatory guidance is provided for when DMC should be considered. The DMC has a special place in review of study oversight. However, many other groups also play roles. This chapter will distinguish the roles of those groups and how they are different from what the DMC do

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https://doi.org/10.1007/978-3-031-79281-6 leading up to having a fully contracted DMC member are discussed. Indemnification is reviewed to ensure DMC members are indemnified by the sponsor, and not the reverse. A detailed review of the different types of conflict of interest (not just financial) is provided. Approaches on DMC member paymen

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https://doi.org/10.1007/978-3-031-79281-6onsibilities and interactions for each of the six directed pathways of these three groups are provided in detail. The concept of the Sponsor Liaison is introduced, with more about the specifics of how DMC recommendations are communicated and with follow-up discussion if needed. The reporting statist

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https://doi.org/10.1007/978-3-031-79281-6Data for DMC purposes typically needs to balance currentness vs. cleanliness. The underlying programming of the DMC outputs can be done by the sponsor or its CRO, or the SDAC supporting the DMC. The advantages and disadvantages of these different approaches are listed – noting the importance that in

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https://doi.org/10.1007/978-3-031-79281-6xpected to be very different from what would be generated at the end of the study for regulatory review. An overview of the safety data (e.g., adverse events, laboratory data), efficacy data (primary endpoint, or at least a proxy for it), and other data (e.g., demographics, disposition, exposure) is