This is the module two of our Good Clinical Practice Course.
This module covers the following chapters.
Chapter 4 – Investigator
- Who is an Investigator?
- Investigator Responsibilities
- Investigator Non-Compliance
- Investigator Scenario
Chapter 5 – Sponsor
- Who is a Sponsor?
- Sponsor Responsibilities
- Quality Management, Risk, QA, QC
- Delegation
- Trial Management, Data Handling and Record Keeping
- Investigator and Monitor Selection
- Sponsor Scenario
Chapter 6 – Monitor
- What is monitoring and why is it necessary?
- Monitoring Approaches
- Monitoring Visits and Reporting
- Monitoring Scenario
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