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The Informed Consent Process from the Monitor's Perspective: Expectations, Best Practices, and Site Corrective and Preventative Actions

Friday, November 08, 2013 — Poster Session III

10:00 a.m. – 12:00 p.m.

FAES Academic Center (Upper-Level Terrace)




  • E Annum
  • R Cox
  • K Watkins


Clinical Research Associates (CRAs)/monitors in the Regulatory Compliance and Human Subjects Protection Program (RCHSPP) Clinical Trials Management (CTM) team are tasked with helping to ensure the rights, safety, and well-being of human subjects participating in research studies. A significant component of human subjects protection is ensuring adequate informed consent prior to study participation. Here, we aim to present an overview of the informed consent process from a monitor’s perspective, focusing on expectations based on regulations and guidelines as well as challenges observed. Informed consent is an ongoing process that must be obtained from all participants prior to completing any study procedures and must be in compliance with applicable federal/local regulations, Good Clinical Practices and Institutional Policies.

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