The sponsor is required to report the following to the MREC both during and after the research:

• Start date
• Changes to the research file (amendments)
• SAEs, SUSARs and SADEs
• Progress report
• Development Safety Update Report
• Periodic SAE line listings
• Periodic SUSAR line listings
• Suspension
• (Early) termination
• Result and publications

If you have any questions about the review and submission procedures, you can consult the page “How to submit”.

Link

• CCMO: During and after the research
• How to submit

^{Participating institutions: UMC Utrecht, Prinses Máxima Centrum for pediatric oncology and Antoni van Leeuwenhoek}