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Clinical Training for CRAs, Medical Staff and Study Site Coordinators

1. Overview of Clinical Research
2. Overview of Conducting a Clinical Trial
3. Identifying and Screening Potential Investigators and Study Sites
4. Patient/Subject Rights
5. Compliance With Government Regulations
6. Interacting With Outside Experts (e.g. central labs, drug destruction facilities, contractor personnel)
7. Performing the Pre-initiation Visit
8. Coordinating and Conducting an Investigator Meeting and/or Individual Investigational Site Training
9. Performing the Initiation Visit
10. Performing Routine Monitoring Visits
11. Source Document Auditing, Verification, and Comparison to CRF Data
12. Adverse Event Documentation and Reporting, Including Serious Adverse Events
13. Performing Safety and Efficacy Assessments
14. Performing Drug Accountability
15. Performing the Close-out Visit
16. Study Termination
17. Regulatory Study Site and Sponsor Audits