GCP General Trainning
CCT organizes clinical trial educational program by contract from time to time. The objectives of the workshops are to understand the basic principles of GCP, clinical trial management and clinical trial designs. The workshops further enhance the clinical research knowledge of the front line research staff including the investigators, study coordinators, research nurses and open to the pharmaceutical industry.
- GCP Workshop (2-hours program)
- Introduction to GCP
- The Responsibility of Investigators
- Delegation of Responsibilities
- Interaction with Ethics Committee
- Clinical Trials Operation
- Standard Operating Procedures
- Protocol Compliances
- Informed Consent Process
- Adverse Event Reporting
- Study Drug Handling
- Study Documentation and Record Keeping
- GCP Fundamental Course (One-day program)
- Overview of GCP
- Ethics Committee
- Informed Consent
- Serious Adverse Event
- Clinical Trial Design and Protocol Development
- Regulatory Requirements
- Study Documentation
- Data Handling and Record Keeping
- Drug Accountability
- Study Closure
- Clinical Trial Monitoring
- Clinical Trial Audit
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