Management and Coordination of Clinical Trial

1. Feasibility study
1.1. Vision of the Study Center
1.2. Promoter’s view
2. Recruitment
3. Conduct of the study
3.1. Coordination
3.2. Monitoring
4. Experimental drug
4.1. Preparation and labelling
4.2. Circuit in the Study Center
4.3. Responsibilities
5. Quality Management
5.1. Quality Management Systems
5.2. Audits and inspections
5.3. Certification and accreditation processes
6. Human Resource Management and organizational requirements
6.1. Leadership and motivation
6.2. International teams
7. Financial management
8. Clinical research indicators

NAO