When can I start my research project?
- WMO
- Non-WMO
Research subject to the WMO
A study can only legally start (i.e. enrollment of the first participant) once the following requirements have been met:
- the study has received approval from the relevant review authority (MREC, CCMO, CTIS or CBT) in writing;
- the authorisation letter from the Executive Board of Amsterdam UMC has been received.
In Amsterdam UMC, the following is also obligatory:
- Setting up a data management plan;
- Monitoring by the Clinical Monitoring Center (CMC).
Note: after a study is approved by the MREC Amsterdam UMC a study record will be created in EPIC. This record includes basic information, such as the MREC number, study acronym and title, status, study type and specialism. In addition, the principal investigator, research coordinator and other authorized employees will be listed in the study record.
Additional requirement for research involving medical devices without a CE mark or used outside intended purpose:
The manufacturer of the device can submit the clinical investigation to the CCMO for validation and obtained a positive validation decision (applicable for MDR article 62/74.2). As a researcher, you are responsible for requesting a copy of this positive validation decision for your study documentation.
Additional reguirements for multicentre research:
A participating centre can get started only after:
- The accredited MREC has approved that specific center for participation;
- The board/management of the participating center has given authorisation for the conduct of the study at their institution; and
- The sponsor recieved a signed Clinical Trial Agreement and study protocol.
Research not subject to the WMO (non-WMO)
A study can only legally start (i.e. enrollment of the first participant) once the non-WMO Review Committee of the MREC Amsterdam UMC declared that the proposed study is not subject to the WMO and issued a non-WMO statement.
The department were the study will be conducted is responsible for ensuring the study complies with all applicable laws and regulations.