During and after the research
During the study, in the completion phase of the study and thereafter, the sponsor is also required to submit information regularly to the review committee.
The sponsor is required to report the following to the review committee (MREC or CCMO) both during and after research with a medicinal product subject to the Dutch WMO Act:
Additional or different regulations for certain types of research
Additional or different regulations apply to reports during and after the study for certain types of research. More information can be found at:
- Clinical trials with medicinal products (CTR)
- Research with medical devices
- Performance studies using in vitro diagnostics (IVDR)
- Research on gene therapy/medicinal product with GMO
- Research with ATMPs: Out of specification (OOS)
How to submit research with a medicinal product subject to the Dutch WMO Act or the Embryo Act
The correct coding and titles of your documents are important for efficient processing of your submission. The review committee checks whether the research file is complete in accordance with the standard research file, therefore it is important you adhere to this classification.
You are required to submit all documents in PDF format via the Research Portal. Secured PDF files are not permitted, not even if the password is given separately.
The submission of substantial amendments must always be accompanied by the submission of a cover letter.