Research Roadmap

Start date

The study start date for research subject to the WMO, MDR or IVDR is defined as the date when the first participant in the Netherlands, at any participating centre, signs the informed consent form. The start date must be reported to the review committee (MREC or CCMO) via the Research Portal. Consult the CCMO website for guidance on using the Research Portal.

For clinical trials involving medicinal products, the CTR defines the study start date as the first act of recruiting a potential participant for the specific clinical trial, unless otherwise defined in the research protocol. The start date must be reported via CTIS.

Other parties to notify upon study start:

• The MREC office of Amsterdam UMC in relation to local approval of the Executive Board (Lokale Uitvoerbaarheid). The start date must be reported via Research Manager.
• The independent expert described in the research protocol, responsible for informing and advising participants about the study;
• The monitoring entity;
• The pharmacy;
• All other facilitating departments, such as the laboratory and radiology.

Validity approval review committee

The approval letter from the review committee states the period during which the positive decision remains valid. If inclusion of participants does not start within this timeframe, the decision will expire, and no further inclusion of participants is permitted under the current research protocol.

Before the expiration of the positive decision, an extension can be requested from the review committee via the Research Portal. This request must include a justification for the extension.