Reporting start of a study
The starting date of a study is the date on which the first subject in the Netherlands, at any participating centre, granted written informed consent (i.e. the date on which the first consent statement was signed). The starting date must be reported to the assessment committee (MREC or CCMO). The competent authority (for device studies, CCMO) need not be notified of this date.
Important: For medicinal trials which must meet the requirements of the ECTR, the date of study start is defined as the first act of recruitment of a potential subject for a specific clinical trial, unless defined differently in the protocol.
Also inform the following involved parties about your study start:
- The independent expert who can adequately inform and advise the subjects about the study, as described in the protocol
- The party who will be performing the monitoring
- The pharmacy (if applicable)
- Any other facilitating departments (e.g. lab, radiology), if applicable
Validation approval reviewing committee
The letter of consent from the MREC states the period during which the positive decision is valid. If the inclusion within your study has not started before this date, the decision will lose its validity, and you will not be able to start including subjects according to the protocol in question.
Before the deadline expires, the reviewing committee and, if applicable, the competent authority can be requested to extend the period of validity of the decision. In order to continue the research, this must be reported to the assessment committee and, if applicable, to the competent authority along with a statement of reasons.