Clinical Research Coordination

This pathway map will help you gain the expertise needed to:

1. Design a clinical trial (identify the components of a clinical trial protocol).
2. Differentiate among the five major regulatory bodies governing human subject research.
3. Describe the role and process for monitoring of the study.
4. Identify ethical issues of using vulnerable populations in research.
5. Explain the Institutional Review Board (IRB) review criteria for expedited, minimal risk, and exempt studies.
6. Differentiate the types and identification process of adverse events (AEs) which occur during clinical trials and the reporting requirements to IRBs, Ethics Committees, other regulatory authorities, and sponsors.
7. Apply management concepts and effective training methods to manage risk and improve quality in the conduct of a clinical research study.
8. Identify required research protocol components.
9. Explain the evolution of the requirement for informed consent from research participants and the principles and content of the key document which ensure the protection of human participants in clinical research.
10. Describe the ethical issues involved when dealing with vulnerable populations and the need for additional safeguards.
11. Prepare a sample study budget for a clinical trial.
12. Practice moral reasoning in scientific research.
13. Summarize at least three confidentiality issues with genetic research.
14. Summarize the legislative and regulatory framework which supports the development and registration of medicines, devices and biological and ensures their safety, efficacy and quality.
15. Prepare basic quality assurance procedures for a research site.
16. Differentiate responsibilities of the IRB, the principal investigator, and the sponsor in the conduct of an investigational device study.
17. Define significant risk (SR) and non-significant risk (NSR) and explain the role of the IRB, the FDA and the sponsor in determining this status.
18. Compare and contrast the routes to market for device manufacturers, including premarket approval (PMA), substantial equivalence, exemption from 510k, extension of a product line, reclassification and humanitarian use.
19. Differentiate at least four legal issues facing IRBs.