This webinar will cover background information and history of clinical research and drug development, followed by review of the federal regulations, International Council for Harmonisation (ICH), and Good Clinical Practices (GCP) that apply to clinical research.
Individuals (healthcare professionals and support staff) involved in planning, conducting, or reporting human subject research must have documented training and working knowledge of the federal regulations, international regulations, and guidelines applied to clinical research.
This webinar is designed to provide an overall understanding and basic knowledge of the history and regulations/guidelines as applied to clinical research. This training will fulfill the requirement of healthcare professional and support staff involved in human subject research to have documented training on regulations and guidelines applied to clinical research.
Why Should You Attend:
In 1938, a newly enacted U.S. Food, Drug, and Cosmetic Act subjected new drugs to pre-market safety evaluation for the first time. The ethical advances in human protection include several milestones - Nuremberg Code, Declaration of Helsinki, Belmont Report, and 1996, International Council for Harmonization Good Clinical Practice (ICH-GCP) guidance, all influencing the regulations and guidelines that are applied to clinical research in the 21st century.Individuals (healthcare professionals and support staff) involved in planning, conducting, or reporting human subject research must have documented training and working knowledge of the federal regulations, international regulations, and guidelines applied to clinical research.
This webinar is designed to provide an overall understanding and basic knowledge of the history and regulations/guidelines as applied to clinical research. This training will fulfill the requirement of healthcare professional and support staff involved in human subject research to have documented training on regulations and guidelines applied to clinical research.
Areas Covered in the Webinar:
- History and outline of milestones in regulation and guidelines of clinical research
- Review federal regulations for clinical research and drug development
- Describe the role of International Council for Harmonisation and how it applies to clinical research
- Discuss responsibilities for individuals working in clinical research
- Discuss best practices in clinical research
- Listing of significant definitions as applied to clinical research
Who Will Benefit:
- Principal Investigators
- Clinical Research Coordinators
- Nurses
- Study Managers
- Screening Coordinators
- Recruitment Staff
- Regulatory Administration
- Quality Staff
- Clinical Research Associates
- Clinical Data Manager
- Clinical Data Specialist
Course Provider
Shana Dressel,
