On this page you find information on i.e.:
- Approaching and informing of subjects (selection, criteria, reflection time, reminder letter yes/no, access to medical file)
- Access and registration personal details subject / medical file (monitoring by whom: monitor/auditor, Ministery of Health Inspectorate, METc), when yes/no)
- Burden for the subject: deviation of standard treatment protocol (is research), reduction of health risks and additional subject insurance applicable or exemption possible
Research with minors and incapacitated persons
A description on circumstances and examples regarding this population which the investigator has to take into account.
The role of the physician and investigator
When the investigator is also the treating physician, special care must be applied when the patient is asked to participate in the clinical trial.
Research with radiation
What are the rules and regulations when radiation is used in the clinical trial.
Collection and storing tissue samples
Which guidelines does the METc have regarding the collection of (additional) tissue samples?
NFU risk classification and monitoring.
How is the risk of a clinical trial determined and why must this be monitored?