Key Topic 2: Non Interventional Studies - Key Considerations
Other key considerations with non interventional studies are:
Investigators
The selection of investigators for Non-Interventional Studies must be based on their relevant expertise.
Selection of investigators must never be based on prescribing practices. Non-Interventional Studies must never be to used to train HCPs on the use of a particular therapy.

Treatment
Treatment with the product must be lawful, on label and in accordance with established local medical practice. Patients must not be given the product for the purpose of taking part in the study. Patients must not be switched to the product for the purpose of taking part in the study.

Agreement
A formal written agreement must be in place and signed by an authorised representative from the Company and the investigator before any Non-Interventional Studies activities are assigned or take place. The agreement must describe
- The scope
- The duration
- The payment for all applicable procedures
