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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SSRIS

What Are the Legal and Financial Aspects of a DMC?, 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 payment are also shown.

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What Does a DMC Meeting Look Like?,ings. This includes DMC kick-off meeting, data review meeting (as well as interim analysis meetings), top-line meetings, and ad hoc meetings. The sessions within a meeting are covered: standard open and closed sessions, recap sessions, and executive sessions. Considerations for meeting format, length, and frequency are provided.

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What Do the Final DMC Outputs Look Like and How Is It Delivered?,the DMC package are provided, so that the DMC can easily but securely receive and – once received – easily review materials. An Executive Summary might be part of this DMC package. Pros and cons about going beyond static outputs are discussed.

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极力证明