Clinical Data Coordination

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

1. Demonstrate general understanding of the `Common Rule` and requirements for sites and sponsors participating in clinical trials.
2. Describe the roles and responsibilities of the clinical investigation team as defined by Good Clinical Practice Guidelines.
3. Describe how global regulations and guidelines assure human subject protection and privacy during the conduct of clinical trials.
4. Discuss the historical events and ethical issues impacting vulnerable populations which precipitated the development of governmental regulatory processes for drugs, devices and biologicals.
5. Complete sample, "Statement of Investigator Federal Form 1572" and addendums for conflict of interest for a clinical research site.
6. Explain the operational and data preparations required for a regulatory site audit and its purpose.
7. Identify physical and non-physical risks associated with research subjects.
8. Explain the Institutional Review Board (IRB) review criteria for expedited, minimal risk, and exempt studies.
9. Analyze the ethical and moral conflicts between local communities and research initiatives.
10. List the documents required for a clinical research site regulatory binder.
11. Compare and contrast a clinical study case report form designs and production formats.
12. Describe the required protocol components documents needed for an IRB new protocol review application.
13. Summarize the legislative and regulatory framework which supports the development and registration of medicines, devices and biological and ensures their safety, efficacy and quality.