Research Roadmap

For studies subject to the WMO

A trial can only legally get underway (i.e. start with the inclusion of first human subjects) when the following items have been taken care of:

• the study has been approved by the reviewing authority (MREC, CCMO, CTIS or CBT); a favourable opinion has been received in writing;
• the approval letter has been received from the EB.

Note: after a study has been approved by the MREC AMC of VUmc a study record will be created in EPIC. The study record contains basic information about the study such as the MREC number, acronym and title of the study, status, study type and specialism. In addition, the principal investigator, research coordinator and other authorized employees will be listed in the study record.

Additional condition for clinical trials involving medicinal products

In addition to a favourable opinion from the authorised MREC, for clinical trials of medicines a statement of no objection must also be obtained from the authorised agency (CCMO/Ministry of Health).

note: the marginal review by the competent authority (CCMO/Ministry of Health) shall be repealed for clinical trials that falls under the scope of the ECTR and submitted via CTIS.

Additional condition for trials of medical devices without CE mark or application outside intended use:

The manufacturer of the device has submitted the trial to the CCMO and obtained a favourable opinion of the validation (applicable for article 62 and 74.2). You as investigator are responsible for requesting this approval from the manufacturer (ask for a copy of the CCMO approval).

For all types of trials subject to the WMO, the following items are obligatory at Amsterdam UMC:

• setting up a data management plan
• having your trial monitored

Additional conditions for multicentre research studies

A participating centre can get started if:

• the MREC authorised for conducting the review has approved that particular centre;
• the board/management of the participating centre has given its consent for the study to be conducted at their institution, and;
• the sponsor recieved a signed Clinical Trial Agreement and protocol.

For studies not subject to the WMO (non-WMO)

A trial can only legally get underway (i.e. start with the inclusion of first human subjects) If the Executive Board of the MREC has declared your proposed investigation not to be subject to the WMO and you have received a non-WMO statement.

The department were the research will be carried out is responsible for the proper conduct of the investigation in accordance with applicable laws and regulations.