The training centre of «IN VIVO» has prepared a training-seminar on «Organization and realization of clinical investigations in compliance with the GCP rules» for CRO employees (monitors, CR assistants), doctors-researchers, members of local committees on ethics and other specialists who participate (or are willing to) in clinical investigation. Regular trainings in this field are a necessary and indispensable condition of a successful realization of any stage of clinical investigations of medicines.
Training-seminar «Organization and realization of clinical investigations in compliance with the GCP rules» includes the following subjects:
1. History of clinical investigations.
2. Phases and kinds of clinical investigations.
3. Planning of clinical investigations.
4. Ethical aspects of clinical investigations. Ethical committees.
5. The informed consent.
6. Protocol of Clinical Investigation.
7. The primary medical documentation of patients.
8. AE and SAE.
9. Rules for working with the material under investigation.
10. Monitoring of Clinical Research.
11. organizations and the development of new medicines.
12. Quality control of clinical research. Audit and inspection.
13. Electronic technologies in clinical research.
14. The data management. The report of the results of the clinical research. Statistical analysis.
Duration of the seminar: 12 academic hours / 2 days. An application for participation in the seminar can be sent by email:firstname.lastname@example.org
After completing their studies at the seminar, the participants will be awarded a special certificate.