- Evaluation of a clinical trial protocol
- Initial documentation in a clinical trial
- Informed Consent Process
- Destruction of the investigational medicinal product
- Storage of investigational medicinal products
- Confidentiality in clinical research
- Adverse Event Management
- Distribution, issuance and accounting of investigational medicinal products
- Collection, handling and transportation of biological samples
- Monitor visits and monitoring log
- Suspension or termination of a clinical trial
- Preparation for inspection