Human Subjects Research Seminar: Current Regulations under FDA and HIPAA 2017 is a seminar that covers topics such as:
- Office for Human Research Protections Guidance
- Department of Health and Human Services regulations, 45 CFR 46
- HIPAA and HI-Tech
- The FDA regulations, 21 CFR 50, 56, 312, 314, 812, 814
- Coercion vs. undue influence
- ICH E6 Good Clinical Practices
- Vulnerable populations
- Recruitment of Research Subjects
- Inclusion of Women and Minorities
- Non-English speaking populations
- Waivers of consent vs. waivers of authorization
- Waivers of consent
- Wards of the State
- Assent vs. consent
- Levels of de-identification what they are and how they affect consent
- Certificates of confidentiality
- Study responsibilities: ICH vs. NIH
- Privacy vs. confidentiality
- Codes of Conduct
- Drug/Device Accountability
- Reporting responsibilities
- Conflicts of Interest
- Investigator-sponsor responsibilities
- Monitoring
- Special concern studies
- Study types
- Common compliance issues
- Standard operating procedures vs. protocol vs. IRB submission
- Adverse event monitoring and reporting including Serious adverse events and unanticipated problems
- Data safety monitoring
- Assurances and Agreements (e.g. MOU)
- Investigational Drug and Device use in clinical trials
- International Ethical Guidelines
- Site Responsibilities
- Applying ICH to international sites
Human Subjects Research Seminar: Current Regulations under FDA and HIPAA 2017 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