Human Subjects Research Seminar: Current Regulations under FDA and HIPAA 2014

Key Topics

• Current Federal Regulations and Agencies involved in Human Research
• The Evolution of Human Experimentation Regulation and Overview of Clinical Research and Ethics in Human Research
• Informed Consent in Clinical Trials
• Selection and Recruitment of Research Subjects
• The Investigator
• Confidentiality of Clinical Trial Information
• The Institutional Review Board
• Research Protocols Lecture 8: Multisite, Community and Collaborative Studies
• Research Under the Food, Drug & Cosmetic Act
• Patient Safety in Clinical Trials Research
• Compliance and Human Research
• International Research
• Accreditation and Risk Management in Clinical Trials

Who should Attend

• Clinical Research Scientists (PKs, Biostatisticians,)
• Principal Investigators / Sub-investigators
• Clinical Research Associates (CRAs) and Coordinators (CRCs)
• Safety Nurses
• QA / QC auditors and staff
• Recruiting staff
• Human Research Protection professionals
• Clinical Research Data managers