Human Subjects Research Seminar: Current Regulations under FDA and HIPAA 2014 is a seminar that covers topics such as:
- 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
Human Subjects Research Seminar: Current Regulations under FDA and HIPAA 2014 brings together:
- 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