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Yvonne Higgins, CIP
Quality Assurance Advisor, Compliance
Biography
Yvonne has contributed to the cause of ethics and responsibility in human research for more than 20 years. During that time, she has served as Vice President of Quality Management for Copernicus Group IRB, Executive Director of the human research protections program (HRPP) and Institutional Review Boards (IRBs) at the University of Pennsylvania, Co-Chair of the workshop and didactic planning committee for PRIM&R’s Advancing Ethical Research annual conference, and Public Health Analyst within the US Department of Health and Human Services Office for Human Research Protections (OHRP).
Latest insights by Yvonne
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Regulatory Compliance
Guidance on genomic research with deceased patients
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Clinical Trial Safety
What are the IRB Reporting Requirements for Adverse Events?
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Questions on regulations for process development and purchased human cells
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Regulatory Compliance
What training documentation is required for conducting clinical research studies?
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What are ethical considerations for a trial with a pre-study washout period?
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Regulatory Compliance
How to resolve irregularities in the documentation of informed consent?
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What are the requirements for submitting protocol deviations?
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Regulatory Compliance
Can we transfer patient data from our CTMS to our parent medical practice?
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What elements of Informed Consent must we include when pre-screening?
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Ethics in Clinical Research