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During and after the research
During and after the research
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”.
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Participating institutions: UMC Utrecht and Prinses Máxima Center for pediatric oncology