[PDF] Data And Safety Monitoring Committees In Clinical Trials Ebook
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Guidance for Clinical Trial Sponsors Guidance for Clinical Trial Sponsors . Establishment and Operation of Clinical Trial Data Monitoring Committees . For questions on the content of this guidance, contact the Office of Communication ... Data Monitoring Committees (DMCs) Clinical Trials ... Randomized clinical trials are increasingly overseen by independent data monitoring committees (DMCs) that monitor trial conduct and safety and make recommendations for trial changes or closure. With the growing use of DMCs, several issues have emerged: 1. Data and Safety Monitoring Committees in Clinical Trials ... Maintaining all the material from the first edition and adding substantial new material, Data and Safety Monitoring Committees in Clinical Trials, Second Edition is ideal for training professionals to serve on their first DMC as well as for experienced clinical and biostatistical DMC members, sponsor and regulatory agency staff.
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