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During and after the research
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
Participating institutions: UMC Utrecht, Prinses Máxima Centrum for pediatric oncology and Antoni van Leeuwenhoek