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Topics

Here you find a short description on how in the UMCG certain things are organised and formalised regarding medical research. It is assumed you already know the general (and legal) framework. A short overview with links is available.
Specific topics are described and includes the elaboration of the position of the METc.

Subject Information

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?

Clincal trials with medical devices.

More information on medical devices and clinical trials.

Medical research in the UMCG

Here you find information regarding medical research in the UMCG and appropriate guidelines and help.

  • Clinical Research Toolbox & UMCG Research Register (more info)
  • ” UMCG Research Code (more info)
Legal framework medical research

Here is just a small list of the rules and regulations where the METc and the investigators are dealing with. A more extensive list can be found on the website of the CCMO (Centrale Commissie Mensgebonden Onderzoek).