Human Subjects Research Seminar: Current Regulations under FDA and HIPAA 2017

  • 2017
  • United States

Description

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

Past Events

Important

Please, check "Human Subjects Research Seminar: Current Regulations under FDA and HIPAA" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Healthcare, Medical device, Medical laboratories, Pharma

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