Compliant Clinical Research Conduct: What Every Clinical Research Professional Needs to Know 2016

Key Topics

• Research with human subjects
• The regulations that [[ apply ]] to FDA-regulated studies and those that apply to federally- funded studies
• Different types of human subjects research
• The typical activities and flow of a study
• The standard items addressed in a clinical trial agreement (CTA)
• Research misconduct
• Key components of good documentation practices
• Conflict of Interest (COI)
• The IRB scope of responsibilities and authority
• Various safeguards for ensuring data integrity
• The key regulatory requirements and good clinical practices that apply in the protection of human subjects during the informed consent process
• The principles of confidentiality and privacy in all clinical research operations
• And take appropriate action when noncompliance is suspected or observed
• The applicable regulations in the clinical research professional`s role of identification, documentation, and reporting of Adverse Events and Unanticipated Problems
• The compliant process for evaluating study billing

Who should Attend

• New Clinical Research Coordinators (1-2 years)
• Healthcare providers interested in exploring the field of Clinical Research
• Administrative managers in charge of Clinical Research
• New Principal Investigators
• Regulatory Compliance Associates and Managers