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 subject to the CTR, the study start date is defined as the first act of recruiting a potential participant for the specific clinical trial, unless otherwise defined in the study protocol. The start date must be reported via CTIS.

Other parties to notify upon study start:

• The independent expert described in the study protocol, responsible for informing and advising participants about the study;
• The party performing the monitoring of the study;
• The pharmacy, if applicable;
• Any other facilitating departments (e.g. lab, radiology), if applicable.

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 study 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.