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ClinicalTrials.gov: Oversight and Compliance at a Diverse Academic Research Center
Melanie Chladny, Research Compliance Specialist, University of Michigan Medical School. Linda Mendelson, Research Compliance Specialist, University of Michigan Rogel Cancer Center.
June 11, 2019
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Speakers will describe the oversight processes, management tools, and structural challenges of a diverse university and large cancer research center. We’ll explain how different administrative roles intersect to achieve effective oversight and compliance
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Presenters will share lessons learned, best practices, and tips to pro-actively manage ClinicalTrials.gov records at a large institution
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We’ll demonstrate how institutions can adapt to ongoing regulatory and policy change using ClinicalTrials.gov: uploading informed consent documents for the Common Rule, meeting the ICMJE’s new data sharing policy, and monitoring NIH funded clinical trials
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