Quality check

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  • New protocol amendment
  • Tracker IMPACT Monitoring plan Quality checks
  • Please complete tracker and IMPACT
  • All things in Place?
  • advice site what need to be filed
  • Follow up with CRAs
  • all documents completed and filed in CF ?
  • TMF quality check
  • Guidelines, SOP
  • updated documents
  • Training
  • approval
  • New Amendment was approved and implmented. Study Manager and Study Lead Monitor think about how to ensure the quality of implementation
  • Request information from local team and to complete trackers. Check and up date Systems (e.g. IMPACT, RAVE) and documents. Inform study team what is missing.
  • Check if the whole process is comprehensible documented
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