Each clinical pediatric hub has SOPs implemented to achieve uniformity of the performance of specific functions.
A working group consisting of staff from the pediatric hubs elaborated minimal requirements for local SOPs for the topics:
- Sponsor and investigator responsibilities in clinical trials performed under Clinical Trials Ordinance (KlinV/OClin)
- Informed consent process
- Qualification and training of research team members
- Safety reporting in clinical studies with medical devices
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