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What is Human Subject Research?

1. Tutorial and Examination on Good Clinical Practice (GCP) Guidelines
2. Communication with Department Chair/Division Chief
3. Protocol Design
4. Consent Forms
5. Investigator's Responsibility List
6. Investigator's Financial Disclosure and Conflict of Interest Statement
7. Advertisements and Recruitment Forms
8. Adverse Events (AE) Reporting to the IRB
9. Confidentiality Agreements, Contracts, Material Transfer Awards
10. Budget Preparation
11. IRB and Research Proposal Oversight Committee
12. Submission of Research Documents
13. Ongoing IRB Issues