Human Subjects Protection

Human Subjects Protection is a seminar that covers topics such as:

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

Human Subjects Protection is intended for:

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

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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