Lokale Prozesse - Hub-spezifisch

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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