ETHICS AS THE FOUNDATION TO CLINICAL RESEARCH
A
COURSE
Investigational drugs and biologics are tested and characterized during and after administration to humans in clinical trials. Therefore the human
subjects that volunteer for these trials should be treated appropriately and their safety should be the primary consideration of all involved in the design
and conduct of these trials. Personal ethics are at the very foundation of our decision-making. The historical ethical principles that have been put in
place to protect human subject rights should be the moral compass to guide all involved. This course describes that role that ethics plays in protecting
human subjects and the design of ethically sound trials. The course will also enhance awareness around emerging trends to he considered in the
future.
L FEATURED TOPICS
• Ethical documents
• Equipoise
• Making ethical decisions
• Emerging trends in clinical research
EUROPEAN UNION CLINICAL TRIALS DIRECTIVE
A
COURSE
This course introduces the basic structure and contents of the European Union Clinical Trials Directive. The course also introduces the Member States’
responsibilities concerning the implementation of the Directive, as well as their current status. Finally, the course discusses the possible effects that the
Directive may have on future clinical research.
L FEATURED TOPICS
• The European Union Clinical Trials Directive
• Member States
• Initiation
• IMPs
• Future Prospects
GOOD CLINICAL PRACTICES (GCPs) FOR NEW PRODUCT INVESTIGATIONS
A
COURSE
This course helps the learner to understand the general requirements of Good Clinical Practices (GCPs) and the protection of human subjects, as well
as provides information regarding the concepts, individuals, and groups involved with them.
L FEATURED TOPICS
• What are Good Clinical Practices
• Regulatory Authority approval for clinical trials
• Clinical Trial Teams
• What GCP requirements/international regulations apply
• Five key GCP documents
