Compliant Clinical Research Conduct: What Every Clinical Research Professional Needs to Know 2016 is a seminar that covers topics such as:
- 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
Compliant Clinical Research Conduct: What Every Clinical Research Professional Needs to Know 2016 brings together:
- 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